Yasser El-Sayed, Professor

All Publications

• Antihypertensive therapy and unplanned maternal postpartum health care utilization in patients with mild chronic hypertension. American journal of obstetrics & gynecology MFM Palatnik, A., Leach, J., Harper, L., Sibai, B., Longo, S., Dugoff, L., Lawrence, K., Hughes, B. L., Bell, J., Edwards, R. K., Gibson, K. S., Rouse, C., Plante, L., Hoppe, K. K., Foroutan, J., Tuuli, M., Simhan, H. N., Frey, H., Rosen, T., Metz, T. D., Baker, S., Kinzler, W., Su, E. J., Krishna, I., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Pereira, L., Magann, E. F., Habli, M., Geller, N. L., Williams, S., McKenna, D. S., Chang, E., Quiñones, J., Szychowski, J. M., Tita, A. T. 2024: 101525

  Abstract

  To test whether treatment of mild chronic hypertension (CHTN) in pregnancy is associated with lower rates of unplanned maternal healthcare utilization postpartum.This was a secondary analysis of the CHTN and pregnancy (CHAP) study, a prospective, open-label, pragmatic, multicenter, randomized treatment trial of pregnant people with mild chronic hypertension. All patients with a postpartum follow-up assessment were included. The primary outcome was unplanned healthcare utilization, defined as unplanned postpartum clinic visits, Emergency Department or triage visits, or unplanned hospital admissions within six weeks postpartum. Differences in outcomes were compared between study groups (Active Group: blood pressure goal of<140/90 mm Hg, and Control Group: blood pressure goal of <160/105 mm Hg) and factors associated with outcomes were examined using logistic regression.A total of 2,293 patients were included with 1,157 (50.5%) in the active group and 1,136 (49.5%) in the control group. Rates of unplanned maternal postpartum health care utilization did not differ between treatment and control groups, (20.2% vs 23.3%, p=0.07, aOR 0.84, 95% CI 0.69-1.03. However, Emergency Department or triage/maternity evaluation unit visits were significantly lower in the Active group (10.2% vs 13.2%, p=0.03, aOR 0.76, 95% 0.58-0.99). Higher BMI at enrollment and cesarean delivery were associated with higher odds of unplanned postpartum healthcare utilization.While treatment of mild CHTN during pregnancy and postpartum was not significantly associated with overall unplanned healthcare resource utilization, it was associated with lower rates of postpartum Emergency Department and triage visits.

  View details for DOI 10.1016/j.ajogmf.2024.101525

  View details for PubMedID 39426624

• Oxytocin regimen used for induction of labor and pregnancy outcomes. American journal of obstetrics & gynecology MFM Reddy, U. M., Sandoval, G. J., Tita, A. T., Silver, R. M., Mallett, G., Hill, K., El-Sayed, Y. Y., Rice, M. M., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Costantine, M. M., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A., Grobman, W. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network 2024: 101508

  Abstract

  BACKGROUND: Following the results of the ARRIVE trial, which demonstrated a reduction in cesarean delivery with no increase in adverse perinatal outcomes after elective induction of labor (IOL) in low-risk nulliparous patients at 39 weeks' gestation compared with expectant management, the use of induction has increased. Current evidence is insufficient to recommend mid-high-dose over low-dose regimens for routine IOL.OBJECTIVE(S): We sought to evaluate the association of oxytocin regimen with cesarean delivery and an adverse perinatal composite outcome in low-risk nulliparous patients undergoing IOL at 39 weeks of gestation or greater.STUDY DESIGN: This is a secondary analysis of the NICHD Maternal-Fetal Medicine Units Network ARRIVE randomized trial. Patients induced with a mid-to high-dose oxytocin regimen (MHD; starting or incremental increase >2 mU/min) were compared with those receiving a low-dose oxytocin regimen (LD; starting and incremental increase ≤2 mU/min). The co-primary outcomes for this secondary analysis were 1) cesarean delivery and 2) composite of perinatal death or severe neonatal complications. Multivariable Poisson regression was used to estimate adjusted relative risks (aRR) and 97.5% confidence intervals (CI) for the co-primary endpoints, 95% CI for binomial outcomes and multinomial logistic regression was used to estimate adjusted odds ratios (aOR) and 95% CIs for multinomial outcomes.RESULTS: Of 6,106 participants enrolled in the primary trial, 2,933 underwent induction with oxytocin: 861 in the MHD group and 2,072 in the LD group. The lower frequency of cesarean delivery in the MHD group compared with the LD group (20.3% vs. 25.2%, RR 0.81, 95%CI (0.69-0.94)) was not significant after adjustment (aRR 0.90, 97.5%CI (0.76-1.07)). The composite of perinatal death or severe neonatal complications was more frequent in the MHD group compared with the LD group (6.7% vs. 4.3%, RR 1.55, 95%CI (1.13-2.14)) and remained significant after adjustment (aRR 1.61, 97.5%CI (1.11-2.35)). The majority of the cases in the composite were from the respiratory support (5.2% vs. 3.1%) component with an increase in transient tachypnea of the newborn (3.8% vs. 2.5%, aRR 1.63, 95% CI (1.04-2.54)). The duration of neonatal respiratory support for one day was significantly higher in the MHD group compared with the LD group (3.5% vs. 1.4%, aRR 2.59, 95%CI (1.52-4.39)); however, support beyond one day was not different between the two groups. The MHD group, when compared with the LD group had a higher operative vaginal delivery rate (10.0% vs. 7.0%, aRR 1.54, 95%CI (1.18-2.00)) and shorter duration of time from start of oxytocin to delivery [crude median (interquartile range) 12 (8-17) vs. 13 (9-19) hours, adjusted median difference -2 (-2 to -1), p<0.001], respectively.CONCLUSION(S): Mid-high-dose oxytocin regimen use for IOL in nulliparas at ≥ 39 weeks' gestation was not associated with improved maternal or neonatal outcomes compared with low-dose regimens. Although mid-high-dose oxytocin regimen use was associated with a shorter duration of labor, there was an increase in self-limited neonatal respiratory support and no difference in cesarean rates. More evidence is needed to define the magnitude of potential maternal and neonatal benefits and risks associated with oxytocin regimens.

  View details for DOI 10.1016/j.ajogmf.2024.101508

  View details for PubMedID 39357802

• Blood Pressure Control in Pregnant Patients with Chronic Hypertension and Diabetes: Should <130/80 be the Target? American journal of obstetrics and gynecology Harper, L. M., Kuo, H. C., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K. S., Haas, D. M., Plante, L., Metz, T. D., Casey, B. M., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Hoppe, K., Foroutan, J., Tuuli, M. G., Owens, M. Y., Simhan, H. N., Frey, H. A., Rosen, T., Palatnik, A., August, P., Reddy, U. M., Kinzler, W., Su, E. J., Krishna, I., Nguyen, N. A., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Galis, Z. S., Ambalavanan, N., Oparil, S., Szychowski, J. M., Tita, A. T. 2024

  Abstract

  The Chronic Hypertension and Pregnancy Study (CHAP) demonstrated that a target blood pressure of <140/90 mm Hg during pregnancy is associated with improved perinatal outcomes. Outside of pregnancy, pharmacologic therapy for patients with diabetes and hypertension is adjusted to a target blood pressure of <130/80 mm Hg. During pregnancy, patients with both diabetes and chronic hypertension may also benefit from tighter control with a target blood pressure (BP) <130/80 mm Hg.We compared perinatal outcomes in patients with hypertension and diabetes who achieved BP <130/80 versus 130-139/80-89 mm Hg.This was a secondary analysis of a multi-center randomized controlled trial. Participants were included in this secondary analysis if they had diabetes diagnosed prior to pregnancy or at <20 weeks' gestation and at least two recorded BP measurements prior to delivery. Average systolic and diastolic BP were calculated using ambulatory antenatal BPs. The primary composite outcome was preeclampsia with severe features, indicated preterm birth <35 weeks, or placental abruption. Secondary outcomes were components of the primary outcome, cesarean delivery, fetal or neonatal death, neonatal intensive care unit (NICU) admission, and small for gestational age (SGA). Comparisons were made between those with an average systolic BP <130 mm Hg and average diastolic BP <80 mm Hg and those with an average systolic blood pressure 130-139 mm Hg or diastolic blood pressure 80-89 mm Hg using Student's t-test and chi-squared tests. Multivariable log-binomial regression models were used to evaluate risk ratios between blood pressure groups for dichotomous outcomes while accounting for baseline covariates.Of 434 participants included, 150 (34.6%) had an average blood pressure less than 130/80 mm Hg. Participants with an average blood pressure less than 130/80 were more likely to be on antihypertensive medications at the start of pregnancy and more likely to have newly diagnosed DM prior to 20 weeks. Participants with an average blood pressure less than 130/80 mm Hg were less likely to have the primary adverse perinatal outcome (19.3% vs 46.5%, adjusted relative risk (aRR) 0.43, 95% CI 0.30-0.61, p<0.01), with decreased risks specifically of preeclampsia with severe features (aRR 0.35, 95% CI 0.23-0.54) and indicated preterm birth prior to 35 weeks (aRR 0.44, 95% CI 0.24-0.79). The risk of NICU admission was lower in the lower blood pressure group (aRR 0.74, 95% CI 0.59-0.94). No differences were noted in cesarean delivery (aRR 1.04, 95% CI 0.90-1.20), fetal or neonatal death (aRR 0.59, 95% CI 0.12-2.92). SGA less than the 10th percentile was lower in the lower blood pressure group (aRR 0.37, 95% CI 0.14-0.96).In those with chronic hypertension and diabetes prior to 20 weeks, achieving an average goal blood pressure of <130/80 mm Hg may be associated with improved perinatal outcomes.

  View details for DOI 10.1016/j.ajog.2024.09.006

  View details for PubMedID 39288828

• Effects of Antihypertensive Therapy During Pregnancy on Postpartum Blood Pressure Control. Obstetrics and gynecology Martin, S. L., Kuo, H. C., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Gibson, K. S., Haas, D. M., Plante, L., Metz, T. D., Casey, B. M., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Foroutan, J., Tuuli, M. G., Owens, M. Y., Simhan, H. N., Frey, H. A., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E. J., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Ambalavanan, N., Oparil, S., Librizzi, R., Pereira, L., Magann, E. F., Habli, M., Williams, S., Mari, G., Pridjian, G., McKenna, D. S., Parrish, M., Chang, E., Osmundson, S., Quinones, J., Werner, E., Szychowski, J. M., Tita, A. T. 2024

  Abstract

  To compare differences in postpartum blood pressure (BP) control (BP below 140/90 mm Hg) for participants with hypertension randomized to receive antihypertensive treatment compared with no treatment during pregnancy.This study was a planned secondary analysis of a multicenter, open-label, randomized controlled trial (The CHAP [Chronic Hypertension and Pregnancy] trial). Pregnant participants with mild chronic hypertension (BP below 160/105 mm Hg) were randomized into two groups: active (antihypertensive treatment) or control (no treatment unless severe hypertension, BP 160/105 mm Hg or higher). Study outcomes were BP control below 140/90 mm Hg (primary) and medication nonadherence based on a composite score threshold (secondary) at the 6-week postpartum follow-up visit. Participants without follow-up BP measurements were excluded from analysis of the BP control outcome. Participants without health care professional-prescribed antihypertensives at delivery were excluded from the analysis of the adherence outcome. Multivariable logistic regression was used to adjust for potential confounders.Of 2,408 participants, 1,684 (864 active, 820 control) were included in the analysis. A greater percentage of participants in the active group achieved BP control (56.7% vs 51.5%; adjusted odds ratio [aOR] 1.22, 95% CI, 1.00-1.48) than in the control group. Postpartum antihypertensive prescription was higher in the active group (81.7% vs 58.4%, P<.001), and nonadherence did not differ significantly between groups (aOR 0.81, 95% CI, 0.64-1.03).Antihypertensive treatment of mild chronic hypertension during pregnancy was associated with better BP control below 140/90 mm Hg in the immediate postpartum period.

  View details for DOI 10.1097/AOG.0000000000005715

  View details for PubMedID 39265175

• Pregnancy Outcomes in Patients With Hepatitis C Virus Infection. Obstetrics and gynecology Hughes, B. L., Sandoval, G. J., Saade, G. R., Clifton, R. G., Reddy, U. M., Bartholomew, A., Salazar, A., Chien, E. K., Tita, A. T., Thorp, J. M., Metz, T. D., Wapner, R. J., Sabharwal, V., Simhan, H. N., Swamy, G. K., Heyborne, K. D., Sibai, B. M., Grobman, W. A., El-Sayed, Y. Y., Casey, B. M., Parry, S., Macones, G. A., Prasad, M., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 2024

  Abstract

  OBJECTIVE: To evaluate the risks of adverse maternal and neonatal outcomes associated with pregnancies complicated by hepatitis C virus (HCV) infection.METHODS: This is a secondary analysis of a multicenter prospective cohort study of HCV infection in pregnancy. Participants were screened for HCV infection with serum antibody tests, and each participant with a positive HCV result (case group) was matched with up to two individuals with negative HCV results (control group) prospectively by gestational age (±2 weeks) at enrollment. Maternal outcomes included gestational diabetes, abruption, preeclampsia or gestational hypertension, cholestasis, and preterm delivery. Neonatal outcomes included hyperbilirubinemia, admission to neonatal intensive care (NICU); small-for-gestational-age (SGA) birth weight; and neonatal infection, defined as sepsis or pneumonia. Models were adjusted for maternal age, body mass index, injection drug use, and maternal medical comorbidities.RESULTS: The 249 individuals in the case group were prospectively matched to 486 individuals in the control group who met eligibility criteria. There were significant differences in demographic characteristics between the groups, including race, socioeconomic markers, education, insurance status, and drug and tobacco use. The frequencies of maternal outcomes of gestational diabetes, preeclampsia, and abruption were similar between the case and control groups. Preterm birth was similar between groups, but neonates born to individuals in the case group were more likely to be admitted to the NICU (45.1% vs 19.0%, adjusted odds ratio [aOR] 2.6, 95% CI, 1.8-3.8) and to have SGA birth weights below the 5th percentile (10.6% vs 3.1%, aOR 2.9, 95% CI, 1.4-6.0). There were no increased odds of hyperbilirubinemia or neonatal infection.CONCLUSION: Despite no increased odds of preterm birth or other adverse maternal outcomes in adjusted analyses, maternal HCV infection was associated with twofold increased odds of NICU admission and nearly threefold increased odds of SGA birth weight below the 5th percentile.

  View details for DOI 10.1097/AOG.0000000000005703

  View details for PubMedID 39173174

• Optimal Timing of Delivery for Pregnant Individuals With Mild Chronic Hypertension. Obstetrics and gynecology Metz, T. D., Kuo, H. C., Harper, L., Sibai, B., Longo, S., Saade, G. R., Dugoff, L., Aagaard, K., Boggess, K., Lawrence, K., Hughes, B. L., Bell, J., Edwards, R. K., Gibson, K. S., Haas, D. M., Plante, L., Casey, B., Esplin, S., Hoffman, M. K., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E. J., Krishna, I., Nguyen, N. A., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Librizzi, R., Pereira, L., Magann, E. F., Habli, M., Williams, S., Mari, G., Pridjian, G., McKenna, D. S., Parrish, M., Chang, E., Quiñones, J., Galis, Z. S., Ambalavanan, N., Sinkey, R. G., Szychowski, J. M., Tita, A. T. 2024

  Abstract

  To investigate the optimal gestational age to deliver pregnant people with chronic hypertension to improve perinatal outcomes.We conducted a planned secondary analysis of a randomized controlled trial of chronic hypertension treatment to different blood pressure goals. Participants with term, singleton gestations were included. Those with fetal anomalies and those with a diagnosis of preeclampsia before 37 weeks of gestation were excluded. The primary maternal composite outcome included death, serious morbidity (heart failure, stroke, encephalopathy, myocardial infarction, pulmonary edema, intensive care unit admission, intubation, renal failure), preeclampsia with severe features, hemorrhage requiring blood transfusion, or abruption. The primary neonatal outcome included fetal or neonatal death, respiratory support beyond oxygen mask, Apgar score less than 3 at 5 minutes, neonatal seizures, or suspected sepsis. Secondary outcomes included intrapartum cesarean birth, length of stay, neonatal intensive care unit admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn, and hypoglycemia. Those with a planned delivery were compared with those expectantly managed at each gestational week. Adjusted odds ratios (aORs) with 95% CIs are reported.We included 1,417 participants with mild chronic hypertension; 305 (21.5%) with a new diagnosis in pregnancy and 1,112 (78.5%) with known preexisting hypertension. Groups differed by body mass index (BMI) and preexisting diabetes. In adjusted models, there was no association between planned delivery and the primary maternal or neonatal composite outcome in any gestational age week compared with expectant management. Planned delivery at 37 weeks of gestation was associated with RDS (7.9% vs 3.0%, aOR 2.70, 95% CI, 1.40-5.22), and planned delivery at 37 and 38 weeks was associated with neonatal hypoglycemia (19.4% vs 10.7%, aOR 1.97, 95% CI, 1.27-3.08 in week 37; 14.4% vs 7.7%, aOR 1.82, 95% CI, 1.06-3.10 in week 38).Planned delivery in the early-term period compared with expectant management was not associated with a reduction in adverse maternal outcomes. However, it was associated with increased odds of some neonatal complications. Delivery timing for individuals with mild chronic hypertension should weigh maternal and neonatal outcomes in each gestational week but may be optimized by delivery at 39 weeks.

  View details for DOI 10.1097/AOG.0000000000005676

  View details for PubMedID 39013178

• In Utero Hematopoietic Stem Cell Transplantation for Fanconi Anemia. Blood advances Swartzrock, L., Dib, C., Denis, M., Willner, H., Ho, K., Haslett, E., Han, J., Pan, W., Byrne-Steele, M., Brown, B., Krampf, M. R., Girsen, A., Blumenfeld, Y. J., El-Sayed, Y. Y., Roncarolo, M. G., MacKenzie, T. C., Czechowicz, A. D. 2024

  View details for DOI 10.1182/bloodadvances.2023011894

  View details for PubMedID 38991119

• Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension. Obstetrics and gynecology Sanusi, A. A., Leach, J., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K. S., Haas, D. M., Plante, L., Metz, T. D., Casey, B., Esplin, S., Longo, S., Hoffman, M. K., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Su, E. J., Krishna, I., Nguyen, N. A., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Harper, L., Ambalavanan, N., Geller, N. L., Kuo, H. C., Sinkey, R. G., Librizzi, R., Pereira, L., Magann, E. F., Habli, M., Williams, S., Mari, G., Pridjian, G., McKenna, D. S., Parrish, M., Chang, E., Osmundson, S., Quinones, J., Szychowski, J. M., Tita, A. T. 2024; 144 (1): 126-134

  Abstract

  To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial.We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding.Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine.No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy.ClinicalTrials.gov, NCT02299414.

  View details for DOI 10.1097/AOG.0000000000005613

  View details for PubMedID 38949541

• Chronic Hypertension During Pregnancy: Prevalence and Treatment in the United States, 2008-2021. Hypertension (Dallas, Tex. : 1979) Leonard, S. A., Siadat, S., Main, E. K., Huybrechts, K. F., El-Sayed, Y. Y., Hlatky, M. A., Atkinson, J., Sujan, A., Bateman, B. T. 2024

  Abstract

  Treatment of chronic hypertension during pregnancy has been shown to reduce the risk of adverse perinatal outcomes. In this study, we examined the prevalence and treatment of chronic hypertension during pregnancy and assessed changes in these outcomes following the release of the updated 2017 hypertension guidelines of the American College of Cardiology and American Heart Association.We analyzed the MerativeTM Marketscan® Research Database of United States commercial insurance claims from 2007 to 2021. We assessed the prevalence of chronic hypertension during pregnancy and oral antihypertensive medication use over time. We then performed interrupted time series analyses to evaluate changes in these outcomes.The prevalence of chronic hypertension steadily increased from 1.8% to 3.7% among 1 900 196 pregnancies between 2008 and 2021. Antihypertensive medication use among pregnant individuals with chronic hypertension was relatively stable (57%-60%) over the study period. The proportion of pregnant individuals with chronic hypertension treated with methyldopa or hydrochlorothiazide decreased (from 29% to 2% and from 11% to 5%, respectively), while the proportion treated with labetalol or nifedipine increased (from 19% to 42% and from 9% to 17%, respectively). The prevalence or treatment of chronic hypertension during pregnancy did not change following the 2017 American College of Cardiology and American Heart Association hypertension guidelines.The prevalence of chronic hypertension during pregnancy doubled between 2008 and 2021 in a nationwide cohort of individuals with commercial insurance. Labetalol replaced methyldopa as the most commonly used antihypertensive during pregnancy. However, only about 60% of individuals with chronic hypertension in pregnancy were treated with antihypertensive medications.

  View details for DOI 10.1161/HYPERTENSIONAHA.124.22731

  View details for PubMedID 38881466

• A Novel Fetal Magnetic Resonance Imaging Lung Volume Nomogram Stratified by Estimated Fetal Weight. Fetal diagnosis and therapy Farladansky-Gershnabel, S., Jayapal, P., Zalcman, M., Barth, R. A., Rubesova, E., Hintz, S. R., Zhang, J., Leonard, S. A., El-Sayed, Y. Y., Blumenfeld, Y. J. 2024: 1-8

  Abstract

  Fetal magnetic resonance imaging (MRI) lung volume nomograms are increasingly used to prognosticate neonatal outcomes in fetuses with suspected pulmonary hypoplasia. However, pregnancies complicated by fetal anomalies associated with pulmonary hypoplasia may also be complicated by fetal growth restriction (FGR). If a small lung volume is suspected in such cases, it is often unclear whether the lungs are "small" because of underlying lung pathology, or small fetal size. Existing MRI lung volume nomograms have mostly been stratified by gestational age (GA), rather than estimated fetal weight (EFW). Therefore, we aimed to develop a novel fetal lung volume nomogram stratified by EFW.Consecutive fetal MRIs performed at a quaternary medical center from 2019 to 2021 were analyzed. MRIs performed due to fetal lung anomalies and cases with FGR were excluded. All MRIs were performed without IV contrast on GE 3 or 1.5 Tesla scanners (GE Healthcare). Images were reviewed by three experienced fetal radiologists. Freehand ROI in square centimeter was drawn around the contours of the lungs on consecutive slices from the apex to the base. The volume of the right, left and total lungs were calculated in mL. Lung volumes were plotted by both EFW and GA.Among 301 MRI studies performed during the study period, 170 cases met inclusion criteria and were analyzed. MRIs were performed between 19- and 38-week gestation, and a sonographic EFW was obtained within a mean of 2.9 days (SD ± 5.5 days, range 0-14 days) of each MRI. Nomograms stratified by both EFW and GA were created using 200 g. and weekly intervals respectively. A formula using EFW to predict total lung volume was calculated: LV = 0.07497804 EFW0.88276 (R2 = 0.87).We developed a novel fetal lung volume nomogram stratified by EFW. If validated, this nomogram may assist clinicians predict outcomes in cases of fetal pulmonary hypoplasia with concomitant FGR.

  View details for DOI 10.1159/000539709

  View details for PubMedID 38843783

• Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension. Obstetrics and gynecology Moore, M. D., Kuo, H. C., Sinkey, R. G., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K. S., Haas, D. M., Plante, L., Metz, T. D., Casey, B., Esplin, S., Longo, S., Hoffman, M. K., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H. A., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E. J., Krishna, I., Nguyen, N. A., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Librizzi, R., Pereira, L., Magann, E. F., Habli, M., Williams, S., Mari, G., Pridjian, G., McKenna, D. S., Parrish, M., Chang, E., Osmundson, S., Quiñones, J. N., Leach, J., Sanusi, A., Galis, Z. S., Harper, L., Ambalavanan, N., Szychowski, J. M., Tita, A. T. 2024

  Abstract

  To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial.A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated.A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations.Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits.ClinicalTrials.gov, NCT02299414.

  View details for DOI 10.1097/AOG.0000000000005611

  View details for PubMedID 38781591

• Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids: The ALPS Follow-Up Study. JAMA Gyamfi-Bannerman, C., Clifton, R. G., Tita, A. T., Blackwell, S. C., Longo, M., de Voest, J. A., O'Shea, T. M., Bousleiman, S. Z., Ortiz, F., Rouse, D. J., Metz, T. D., Saade, G. R., Rood, K. M., Heyborne, K. D., Thorp, J. M., Swamy, G. K., Grobman, W. A., Gibson, K. S., El-Sayed, Y. Y., Macones, G. A. 2024

  Abstract

  The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids.To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes.Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022.Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart.The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up.Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups.In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.

  View details for DOI 10.1001/jama.2024.4303

  View details for PubMedID 38656759

• Magnesium sulfate and risk of hypoxic ischemic encephalopathy in a high-risk cohort. American journal of obstetrics and gynecology Minor, K. C., Liu, J., Druzin, M. L., El-Sayed, Y. Y., Hintz, S. R., Bonifacio, S. L., Leonard, S. A., Lee, H. C., Profit, J., Karakash, S. D. 2024

  Abstract

  Hypoxic ischemic encephalopathy contributes to morbidity and mortality among neonates ≥ 360 weeks' gestation. Evidence of preventative antenatal treatment is limited. Magnesium sulfate has neuroprotective properties among preterm fetuses. Hypertensive disorders of pregnancy are a risk factor for hypoxic ischemic encephalopathy and magnesium sulfate is recommended for maternal seizure prophylaxis among patients with pre-eclampsia with severe features.1) Determine trends in incidence of hypertensive disorders of pregnancy, antenatal magnesium sulfate and hypoxic ischemic encephalopathy, 2) evaluate the association between hypertensive disorders of pregnancy and hypoxic ischemic encephalopathy and 3) evaluate if, among patients with hypertensive disorders of pregnancy, the odds of hypoxic ischemic encephalopathy is mitigated by receipt of antenatal magnesium sulfate. STUDY DESIGN: We conducted an analysis of a prospective cohort of live births ≥360 weeks' gestation between 2012-2018 within the California Perinatal Quality Care Collaborative registry, linked with the California Department of Health Care Access and Information files. We used Cochran-Armitage tests to assess trends in hypertensive disorders, encephalopathy diagnoses, and magnesium sulfate utilization, and compared demographic factors between patients with or without hypertensive disorders of pregnancy or treatment with magnesium sulfate. Hierarchical logistic regression models were built to explore if hypertensive disorders of pregnancy were associated with any severity and moderate/severe hypoxic ischemic encephalopathy. Separate hierarchical logistic regression models were built among those with hypertensive disorders of pregnancy to evaluate the association of magnesium sulfate with hypoxic ischemic encephalopathy.Among 44,314 unique infants, the diagnosis of hypoxic ischemic encephalopathy, maternal hypertensive disorders of pregnancy and the use of magnesium sulfate increased over time. Compared to patients with hypertensive disorders of pregnancy alone, patients with hypertensive disorders treated with magnesium sulfate represented a higher risk population. They were more likely to be publicly insured, born 36-38 weeks' gestation, be small for gestational age, have lower Apgar scores, require a higher level of resuscitation at delivery, have prolonged rupture of membranes, preterm labor, fetal distress, and undergo operative delivery (all p-values <0.002). Hypertensive disorders of pregnancy were associated with hypoxic ischemic encephalopathy (aOR 1.26, 95% CI 1.13-1.40, p-value <.001) and specifically moderate/severe hypoxic ischemic encephalopathy (aOR 1.26, 95% CI 1.11-1.42, p-value <.001). Among patients with hypertensive disorders of pregnancy, treatment with magnesium sulfate was associated with 29% reduction in the odds of neonatal hypoxic ischemic encephalopathy (aOR 0.71, 95% CI 0.52-0.97, p-value= 0.03) and a 37% reduction in the odds of moderate/severe neonatal hypoxic ischemic encephalopathy (aOR 0.63, 95% CI 0.42-0.94, p-value=0.03).Hypertensive disorders of pregnancy are associated with hypoxic ischemic encephalopathy and specifically, moderate/severe disease. Among people with hypertensive disorders, receipt of antenatal magnesium sulfate is associated with significant reduction in the odds of hypoxic ischemic encephalopathy and moderate/severe disease in a neonatal cohort admitted to the NICU ≥360 weeks' gestation. The findings of this observational study cannot prove causality and are intended to be hypothesis generating for future clinical trials on MgSO4 in term infants.

  View details for DOI 10.1016/j.ajog.2024.04.001

  View details for PubMedID 38580044

• Breastfeeding Initiation, Duration, and Associated Factors Among People With Hepatitis C Virus Infection. Obstetrics and gynecology Grasch, J. L., de Voest, J. A., Saade, G. R., Hughes, B. L., Reddy, U. M., Costantine, M. M., Chien, E. K., Tita, A. T., Thorp, J. M., Metz, T. D., Wapner, R. J., Sabharwal, V., Simhan, H. N., Swamy, G. K., Heyborne, K. D., Sibai, B. M., Grobman, W. A., El-Sayed, Y. Y., Casey, B. M., Parry, S. 2024

  Abstract

  To characterize breastfeeding behaviors and identify factors associated with breastfeeding initiation among people with hepatitis C virus (HCV) infection.We conducted a secondary analysis of a multicenter observational cohort of pregnant people with singleton gestations and HCV seropositivity. This analysis includes individuals with data on breastfeeding initiation and excludes those with human immunodeficiency virus (HIV) co-infection. The primary outcome was self-reported initiation of breastfeeding or provision of expressed breast milk. Secondary outcomes included duration of breastfeeding. Demographic and obstetric characteristics were compared between those who initiated breastfeeding and those who did not to identify associated factors. Univariable and multivariable analyses were performed.Overall, 579 individuals (75.0% of participants in the parent study) were included. Of those, 362 (62.5%) initiated breastfeeding or provided breast milk to their infants, with a median duration of breastfeeding of 1.4 months (interquartile range 0.5-6.0). People with HCV viremia, defined as a detectable viral load at any point during pregnancy, were less likely to initiate breastfeeding than those who had an undetectable viral load (59.4 vs 71.9%, adjusted odds ratio [aOR] 0.61, 95% CI, 0.41-0.92). People with private insurance were more likely to initiate breastfeeding compared with those with public insurance or no insurance (80.0 vs 60.1%; aOR 2.43, 95% CI, 1.31-4.50).Although HCV seropositivity is not a contraindication to breastfeeding regardless of viral load, rates of breastfeeding initiation were lower among people with HCV viremia than among those with an undetectable viral load.ClinicalTrials.gov, NCT01959321.

  View details for DOI 10.1097/AOG.0000000000005499

  View details for PubMedID 38176013

• Mifepristone as an adjunct to transcervical balloon for labor induction (MiLI): a randomized controlled trial Miller, H. E., Jennings, M. T., Leonard, S. A., Mayo, J. A., Lyell, D. J., El Sayed, Y. Y., Blumenthal, P., Shaw, K. MOSBY-ELSEVIER. 2024: S140-S141

  View details for Web of Science ID 001282913901061

• Intrahepatic Cholestasis of Pregnancy and Transaminitis in Women with COVID-19: A Case Series. AJP reports Waldrop, A. R., Henkel, A., Lee, K. B., Druzin, M. L., Aziz, N., El-Sayed, Y., Lyell, D. J. 2024; 14 (1): e16-e18

  Abstract

  Objective  The four initial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected pregnant women presenting at term gestation to our institution presented with transaminitis. Three of the four were diagnosed with intrahepatic cholestasis of pregnancy (IHCP). Growing evidence exists of an associated transaminitis in nonpregnant SARS-CoV-2 patients. However, there are limited data of hepatic involvement of SARS-CoV-2 in pregnancy, and no previous studies have assessed the association with IHCP in patients with coronavirus disease 2019 (COVID-19). Study Design  This was a retrospective, single-center case series of four consecutive pregnant women with a positive result for SARS-CoV-2 presenting with transaminitis in third trimester. Results  The clinical courses of four pregnant women with COVID-19 and transaminitis, three of four of whom were diagnosed with IHCP, are described. Testing for SARS-CoV-2 was done through a reverse transcription polymerase chain reaction test of a nasopharyngeal swab. Conclusion  As we await larger studies ascertaining the incidence of IHCP in SARS-CoV-2, this prevalence highlights the importance of diagnosing IHCP among women with COVID-19 as a potential etiology of transaminitis, as IHCP risks may be ameliorated with earlier delivery. Moreover, delineating a hepatobiliary association in pregnancy may provide further information about the mechanism of liver impairment in SARS-CoV-2 in all patients.

  View details for DOI 10.1055/s-0043-1777999

  View details for PubMedID 38269122

  View details for PubMedCentralID PMC10805562

• Randomized Trial of Hyperimmune Globulin for Congenital CMV Infection - 2-Year Outcomes. The New England journal of medicine Hughes, B. L., Clifton, R. G., Rouse, D. J., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., Pass, R., Allard, D., Mallett, G., MacPherson, C., Wapner, R., Metz, T., Goodnight, W. H., Tita, A. T., Costantine, M. M., Swamy, G. K., Heyborne, K. D., Chien, E. K., Chauhan, S. P., El-Sayed, Y. Y., Casey, B. M., Parry, S., Simhan, H. N., Napolitano, P. G., Macones, G. A. 2023; 389 (19): 1822-1824

  View details for DOI 10.1056/NEJMc2308286

  View details for PubMedID 37937785

• Assessing Effectiveness of Intrauterine Postpartum Hemorrhage-Control Devices. Obstetrics and gynecology El-Sayed, Y. Y. 2023; 142 (5): 998-999

  View details for DOI 10.1097/AOG.0000000000005396

  View details for PubMedID 37856851

• Perinatal Outcomes Associated With Management of Stage 1 Hypertension. Obstetrics and gynecology Bailey, E. J., Tita, A. T., Leach, J., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K., Haas, D. M., Plante, L., Metz, T. D., Casey, B. M., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Foroutan, J., Tuuli, M. G., Owens, M. Y., Simhan, H. N., Frey, H. A., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E. J., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Harper, L., Ambalavanan, N., Oparil, S., Kuo, H. C., Szychowski, J. M., Hoppe, K. 2023

  Abstract

  To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130-139/80-89 mm Hg and pregnancy outcomes.We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130-139/80-89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA).Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130-139/80-89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38-0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA.In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA.ClinicalTrials.gov, NCT02299414.

  View details for DOI 10.1097/AOG.0000000000005410

  View details for PubMedID 37769314

• Risk Factors for Perinatal Transmission of Hepatitis C Virus. Obstetrics and gynecology Prasad, M., Saade, G. R., Clifton, R. G., Sandoval, G. J., Hughes, B. L., Reddy, U. M., Bartholomew, A., Salazar, A., Chien, E. K., Tita, A. T., Thorp, J. M., Metz, T. D., Wapner, R. J., Sabharwal, V., Simhan, H. N., Swamy, G. K., Heyborne, K. D., Sibai, B. M., Grobman, W. A., El-Sayed, Y. Y., Casey, B. M., Parry, S., Rathore, M., Diaz-Velasco, R., Puga, A. M., Wiznia, A., Kovacs, A., Garry, D. J., Macones, G. A. 2023; 142 (3): 449-456

  Abstract

  To estimate the rate of perinatal transmission of hepatitis C virus (HCV) infection, to identify risk factors for perinatal transmission of HCV infection, and to determine the viremic threshold for perinatal transmission.This was a prospective, multicenter, observational study of pregnant individuals at less than 24 weeks of gestation screened for HCV infection from 2012 to 2018 in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Individuals found to be HCV antibody-positive were followed throughout pregnancy. Children were followed for evidence of perinatal transmission at 2-6 months (HCV RNA testing) and at 18-24 months (HCV RNA and antibody testing) of life. The primary outcome was perinatal transmission, defined as positive test results at either follow-up time point.A total of 109,379 individuals were screened for HCV infection. Of the 1,224 participants who screened positive, 772 (63.1%) enrolled and 432 of those 772 (56.0%) had data available to assess primary outcome. The overall rate of perinatal transmission was 6.0% (26/432, 95% CI 4.0-8.7%). All children with HCV infection were born to individuals with demonstrable viremia. In viremic participants (n=314), the perinatal transmission rate was 8.0% (95% CI 5.2-11.5%). Risk factors for perinatal transmission included HCV RNA greater than 106 international units/mL (adjusted odds ratio [aOR] 8.22, 95% CI 3.16-21.4) and vaginal bleeding reported at any time before delivery (aOR 3.26, 95% CI 1.32-8.03). A viremic threshold for perinatal transmission could not be established.Perinatal transmission of HCV infection was limited to viremic individuals. High viral loads and antepartum bleeding were associated with perinatal transmission.

  View details for DOI 10.1097/AOG.0000000000005306

  View details for PubMedID 37590978

• Abortion Bans and Resource Utilization for Congenital Heart Disease: A Decision Analysis. Obstetrics and gynecology Miller, H. E., Fraz, F., Zhang, J., Henkel, A., Leonard, S. A., Maskatia, S. A., El-Sayed, Y. Y., Blumenfeld, Y. J. 2023

  Abstract

  To investigate the implications of potential national abortion ban scenarios on the incidence of neonatal single-ventricle cardiac defects.A decision tree model was developed to predict the incidence of neonatal single-ventricle cardiac defects and related outcomes in the United States under four theoretical national abortion bans: 1) abortion restrictions in existence immediately before the June 2022 Dobbs v Jackson Women's Health Organization Supreme Court decision, 2) 20 weeks of gestation, 3) 13 weeks of gestation, and 4) a complete abortion ban. The model included incidence of live births of neonates with single-ventricle cardiac defects, neonatal heart surgery (including heart transplant and extracorporeal membrane oxygenation [ECMO]), and neonatal death. Cohort size was based on national pregnancy incidence and different algorithm decision point probabilities were aggregated from the existing literature. Monte Carlo simulations were conducted with 10,000 iterations per model.In the scenario before the Dobbs decision, an estimated 6,369,000 annual pregnancies in the United States resulted in 1,006 annual cases of single-ventricle cardiac defects. Under a complete abortion ban, the model predicted a 53.7% increase in single-ventricle cardiac defects, or an additional 9 cases per 100,000 live births. This increase would result in an additional 531 neonatal heart surgeries, 16 heart transplants, 77 ECMO utilizations, and 102 neonatal deaths annually. More restrictive gestational age-based bans are predicted to confer increases in cases of neonatal single-ventricle cardiac defects and related adverse outcomes as well.Universal abortion bans are estimated to increase the incidence of neonatal single-ventricle cardiac defects, associated morbidity, and resource utilization. States considering limiting abortion should consider the implications on the resources required to care for increasing number of children that will be born with significant and complex medical needs, including those with congenital heart disease.

  View details for DOI 10.1097/AOG.0000000000005291

  View details for PubMedID 37535962

• Breastfeeding initiation and duration among people with mild chronic hypertension: A secondary analysis of the Chronic Hypertension and Pregnancy (CHAP) trial. American journal of obstetrics & gynecology MFM Goulding, A. N., Antoniewicz, L., Leach, J. M., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Edwards, R. K., Gibson, K., Haas, D. M., Plante, L., Metz, T. D., Casey, B., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., Reddy, U. M., Kinzler, W., Su, E., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Harper, L. M., Ambalavanan, N., Oparil, S., Szychowski, J. M., Tita, A. T. 2023: 101086

  Abstract

  Increased duration of breastfeeding improves maternal cardiovascular health and may be especially beneficial in high-risk populations, such as those with chronic hypertension. Others have shown that individuals with hypertension are less likely to breastfeed, and there has been limited research aimed at supporting breastfeeding goals in this population. The impact of perinatal blood pressure control on breastfeeding outcomes among people with chronic hypertension is unknown.The aim of this study was to evaluate whether breastfeeding initiation and short-term duration assessed at the postpartum clinic visit differed based on perinatal blood pressure treatment strategy (targeting blood pressure <140/90 mm Hg vs. reserving antihypertensive treatment for blood pressure ≥160/105 mm Hg).We performed a secondary analysis of the Chronic Hypertension and Pregnancy (CHAP) Trial. This was an open-label, multicenter, randomized trial where pregnant participants with mild chronic hypertension were randomized to receive antihypertensive medications with goal blood pressure <140/90 mm Hg (active treatment) or deferred treatment until blood pressure ≥160/105 mm Hg (control). Primary outcome was initiation and duration of breastfeeding, assessed at the postpartum clinic visit. We performed bivariate analyses and log-binomial and cumulative logit regression models, adjusting models for variables that were unbalanced in bivariate analyses. We performed additional analyses to explore the relationship between breastfeeding duration and blood pressure measurements at the postpartum visit.1444/2408 (60%) participants from the CHAP trial attended the postpartum study visit and provided breastfeeding information. Participants in the active treatment group had different body mass index class distribution and earlier gestational age at enrollment, and (by design) were more often discharged on antihypertensives. Breastfeeding outcomes did not differ significantly by treatment group. In the active and control treatment groups, 563 (77.5%) and 561 (78.1%) initiated breastfeeding, and mean duration of breastfeeding was 6.5 ± 2.3 and 6.3 ± 2.1 weeks, respectively. The probability of ever breastfeeding (aRR 0.99, 95% CI 0.93-1.05), current breastfeeding at postpartum visit (aRR 1.01, 95% CI 0.94-1.10), and weeks of breastfeeding (aOR 0.87, 95% CI 0.68-1.12) did not differ by treatment group. Increased duration (≥2 weeks vs. <2 weeks) of breastfeeding was associated with slightly lower blood pressure measurements at the postpartum visit, but these differences were not significant in adjusted models.In a secondary analysis of the cohort of CHAP participants who attended the postpartum study visit and provided breastfeeding information (60% of original trial participants), breastfeeding outcomes did not differ significantly by treatment group. This suggests that maintaining goal blood pressure <140/90 mm Hg throughout the perinatal period is associated with neither harm nor benefit for short-term breastfeeding goals. Further study is needed to understand long-term breastfeeding outcomes among individuals with chronic hypertension and how to support this population in achieving their breastfeeding goals.

  View details for DOI 10.1016/j.ajogmf.2023.101086

  View details for PubMedID 37437694

• Treatment of Fetal Cystic Fibrosis With Cystic Fibrosis Transmembrane Conductance Regulator Modulation Therapy. Annals of internal medicine Blumenfeld, Y. J., Hintz, S. R., Aziz, N., Barth, R. A., Spano, J. M., El-Sayed, Y. Y., Milla, C. 2023

  View details for DOI 10.7326/L23-0112

  View details for PubMedID 37307583

• Maternal and Delivery Characteristics and Self-Reported Perceived Control During Labor. Obstetrics and gynecology Mallett, G., Hill, K., Doherty, L., Grobman, W. A., Reddy, U. M., Tita, A. T., Silver, R. M., Rice, M. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Costantine, M. M., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A. 2023

  Abstract

  To evaluate the association between maternal and delivery characteristics and self-reported perceived control during childbirth.A secondary analysis of a multicenter randomized trial was conducted to compare labor induction at 39 weeks of gestation with expectant management in low-risk nulliparous people. Six to 96 hours after delivery, participants who experienced labor completed the Labor Agentry Scale, a validated self-administered questionnaire to ascertain perceived control during childbirth. Scores range from 29 to 203, with higher scores indicating a sense of greater control. Multivariable linear regression was used to determine which maternal and delivery characteristics were associated with the Labor Agentry Scale score. Eligible characteristics included age, self-reported race and ethnicity, marital status, employment status, type of insurance, previous pregnancy loss before 20 weeks of gestation, body mass index (BMI), smoking, alcohol use, mode of delivery, labor pain (0-10 points), and a composite of perinatal death or severe neonatal complications. Significant variables (P<.05) were retained in the final multivariable model, and adjusted mean differences (95% CIs) between groups were estimated.Of 6,106 people enrolled in the trial, 6,038 experienced labor, of whom 5,750 (95.2%) completed the Labor Agentry Scale and were included in this analysis. Mean [95% CI] adjusted Labor Agentry Scale scores were significantly lower among those who identified as Asian (-6.4 [-10.5 to -2.3]) or Hispanic (-3.7 [-5.7 to -1.7]) compared with White, smoked compared with did not smoke (-2.8 [-5.5 to -0.1]), had BMIs of 35 or higher compared with less than 30 (-2.0 [-3.8 to -0.2]), were unemployed (-3.15 [-4.76 to -1.55]), did not have private health insurance (-2.61 [-4.47 to -0.76]), underwent operative vaginal (-5.1 [-7.7 to -2.6]) or cesarean (-14.4 [-16.1 to -12.6]) delivery compared with spontaneous vaginal delivery, and reported greater labor pain score of 8 or higher compared with less than 8 (-11.9 [-13.4 to -10.4]). Mean [95% CI] adjusted Labor Agentry Scale scores were significantly higher among people who were employed compared with unemployed (3.2 [1.6-4.8]) and had private compared with nonprivate insurance (2.6 [0.76-4.5]).In nulliparous people at low risk, unemployment, lack of private health insurance, Asian race, Hispanic ethnicity, smoking, operative delivery, and more labor pain were associated with lower perceived control during labor.ClinicalTrials.gov, NCT01990612.

  View details for DOI 10.1097/AOG.0000000000005230

  View details for PubMedID 37290106

• Clinical and Physician Factors Associated With Failed Operative Vaginal Delivery. Obstetrics and gynecology Panelli, D. M., Leonard, S. A., Joudi, N., Judy, A. E., Bianco, K., Gilbert, W. M., Main, E. K., El-Sayed, Y. Y., Lyell, D. J. 2023

  Abstract

  To examine clinical and physician factors associated with failed operative vaginal delivery among individuals with nulliparous, term, singleton, vertex (NTSV) births.This was a retrospective cohort study of individuals with NTSV live births with an attempted operative vaginal delivery by a physician between 2016 and 2020 in California. The primary outcome was cesarean birth after failed operative vaginal delivery, identified using linked diagnosis codes, birth certificates, and physician licensing board data stratified by device type (vacuum or forceps). Clinical and physician-level exposures were selected a priori, defined using validated indices, and compared between successful and failed operative vaginal delivery attempts. Physician experience with operative vaginal delivery was estimated by calculating the number of operative vaginal delivery attempts made per physician during the study period. Multivariable mixed effects Poisson regression models with robust standard errors were used to estimate risk ratios of failed operative vaginal delivery for each exposure, adjusted for potential confounders.Of 47,973 eligible operative vaginal delivery attempts, 93.2% used vacuum and 6.8% used forceps. Of all operative vaginal delivery attempts, 1,820 (3.8%) failed; the success rate was 97.3% for vacuum attempts and 82.4% for forceps attempts. Failed operative vaginal deliveries were more likely with older patient age, higher body mass index, obstructed labor, and neonatal birth weight more than 4,000 g. Between 2016 and 2020, physicians who attempted more operative vaginal deliveries were less likely to fail. When vacuum attempts were successful, physicians who conducted them had a median of 45 vacuum attempts during the study period, compared with 27 attempts when vacuum attempts were unsuccessful (adjusted risk ratio [aRR] 0.95, 95% CI 0.93-0.96). When forceps attempts were successful, physicians who conducted them had a median of 19 forceps attempts, compared with 11 attempts when forceps attempts were unsuccessful (aRR 0.76, 95% CI 0.64-0.91).In this large, contemporary cohort with NTSV births, several clinical factors were associated with operative vaginal delivery failure. Physician experience was associated with operative vaginal delivery success, more notably for forceps attempts. These results may provide guidance for physician training in maintenance of operative vaginal delivery skills.

  View details for DOI 10.1097/AOG.0000000000005181

  View details for PubMedID 37141591

• Outcomes Following Extracorporeal Membrane Oxygenation for Severe COVID-19 in Pregnancy or Post Partum. JAMA network open Byrne, J. J., Shamshirsaz, A. A., Cahill, A. G., Turrentine, M. A., Seasely, A. R., Eid, J., Rouse, C. E., Richley, M., Raghuraman, N., Naqvi, M., El-Sayed, Y. Y., Badell, M. L., Cheng, C., Liu, J., Adhikari, E. H., Patel, S. S., O'Neil, E. R., Ramsey, P. S. 2023; 6 (5): e2314678

  Abstract

  Importance: Existing reports of pregnant patients with COVID-19 disease who require extracorporeal membrane oxygenation (ECMO) are limited, with variable outcomes noted for the maternal-fetal dyad.Objective: To examine maternal and perinatal outcomes associated with ECMO used for COVID-19 with respiratory failure during pregnancy.Design, Setting, and Participants: This retrospective multicenter cohort study examined pregnant and postpartum patients who required ECMO for COVID-19 respiratory failure at 25 hospitals across the US. Eligible patients included individuals who received care at one of the study sites, were diagnosed with SARS-CoV-2 infection during pregnancy or up to 6 weeks post partum by positive nucleic acid or antigen test, and for whom ECMO was initiated for respiratory failure from March 1, 2020, to October 1, 2022.Exposures: ECMO in the setting of COVID-19 respiratory failure.Main outcome and measures: The primary outcome was maternal mortality. Secondary outcomes included serious maternal morbidity, obstetrical outcomes, and neonatal outcomes. Outcomes were compared by timing of infection during pregnancy or post partum, timing of ECMO initiation during pregnancy or post partum, and periods of circulation of SARS-CoV-2 variants.Results: From March 1, 2020, to October 1, 2022, 100 pregnant or postpartum individuals were started on ECMO (29 [29.0%] Hispanic, 25 [25.0%] non-Hispanic Black, 34 [34.0%] non-Hispanic White; mean [SD] age: 31.1 [5.5] years), including 47 (47.0%) during pregnancy, 21 (21.0%) within 24 hours post partum, and 32 (32.0%) between 24 hours and 6 weeks post partum; 79 (79.0%) had obesity, 61 (61.0%) had public or no insurance, and 67 (67.0%) did not have an immunocompromising condition. The median (IQR) ECMO run was 20 (9-49) days. There were 16 maternal deaths (16.0%; 95% CI, 8.2%-23.8%) in the study cohort, and 76 patients (76.0%; 95% CI, 58.9%-93.1%) had 1 or more serious maternal morbidity events. The largest serious maternal morbidity was venous thromboembolism and occurred in 39 patients (39.0%), which was similar across ECMO timing (40.4% pregnant [19 of 47] vs 38.1% [8 of 21] immediately postpartum vs 37.5% postpartum [12 of 32]; P>.99).Conclusions and Relevance: In this multicenter US cohort study of pregnant and postpartum patients who required ECMO for COVID-19-associated respiratory failure, most survived but experienced a high frequency of serious maternal morbidity.

  View details for DOI 10.1001/jamanetworkopen.2023.14678

  View details for PubMedID 37213099

• Vaginal Progesterone is Associated with Intrahepatic Cholestasis of Pregnancy. American journal of perinatology Tsur, A., Leonard, S. A., Kan, P., Datoc, I., Girsen, A., Shaw, G. M., Stevenson, D. K., El-Sayed, Y. Y., Druzin, M. L., Blumenfeld, Y. J. 2023

  Abstract

  Background The frequency of intrahepatic cholestasis of pregnancy peaks during the third trimester of pregnancy when plasma progesterone levels are highest. Furthermore, twin pregnancies are characterized by higher progesterone levels than singletons, and have a higher frequency of cholestasis. Therefore, we hypothesized that exogenous progestogens administered for reducing the risk of spontaneous preterm birth may increase the risk of cholestasis. Objectives Utilizing the large IBM MarketScan Commercial Claims and Encounters Database, we investigated the frequency of cholestasis in patients treated with vaginal progesterone or intramuscular 17alpha-hydroxyprogesterone caproate for the prevention of preterm birth. Study design We identified 1,776,092 live-born singleton pregnancies between 2010-2014. We confirmed 2nd and 3rd trimester administration of progestogens by cross-referencing the dates of progesterone prescriptions with the dates of scheduled pregnancy events such as nuchal translucency scan, fetal anatomy scan, glucose challenge test, and Tdap vaccination. We excluded pregnancies with missing data regarding timing of scheduled pregnancy events, or progesterone treatment prescribed only during the 1st trimester. Cholestasis of pregnancy was identified based on prescriptions for ursodeoxycholic acid. We used multivariable logistic regression to estimate adjusted (for maternal age) odds ratios for cholestasis in patients treated with vaginal progesterone, and in patients treated with 17alpha-hydroxyprogesterone caproate compared to those not treated with any type of progestogen (the reference group). Results The final cohort consisted of 870,599 pregnancies. Among patients treated with vaginal progesterone during the 2nd and 3rd trimester, the frequency of cholestasis was significantly higher than the reference group (0.75% vs 0.23%, aOR 3.16, 95% CI 2.23-4.49). In contrast, there was no significant association between 17alpha-hydroxyprogesterone caproate and cholestasis (0.27%, aOR 1.12, 95% CI 0.58-2.16) Conclusions Using a robust dataset, we observed that vaginal progesterone but not intramuscular 17alpha-hydroxyprogesterone caproate was associated with an increased risk for intrahepatic cholestasis of pregnancy.

  View details for DOI 10.1055/a-2081-2573

  View details for PubMedID 37100422

• Increased rates of postpartum emergency department visits and inpatient readmissions in people with epilepsy Darmawan, K. F., Leonard, S. A., Meador, K., McElrath, T. F., Carmichael, S. L., Lyell, D. J., El-Sayed, Y. Y., Herrero, T., Druzin, M. L., Panelli, D. M. MOSBY-ELSEVIER. 2023: S163

  View details for Web of Science ID 000909337400235

• Fasting Compared With Fed and Oral Intake Before the 1-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial. Obstetrics and gynecology Sperling, M. M., Leonard, S. A., Miller, S. E., Hurtado, J., El-Sayed, Y. Y., Herrero, T., Faig, J., Carter, S., Blumenfeld, Y. J. 2023; 141 (1): 126-133

  Abstract

  OBJECTIVE: To evaluate the effect of fasting compared with eating before the 1-hour oral glucose tolerance test (OGTT) on gestational diabetes mellitus (GDM) screening results.METHODS: In a single-center, prospective randomized trial, participants were randomized to: 1) fasting for 6 or more hours or 2) oral intake ("fed") within 2 hours of the 50-g, 1-hour OGTT. The 1-hour OGTT was administered after 24 weeks of gestation. A positive screen result was defined as a serum glucose level of 140 mg/dL or higher. Protocol adherence was assessed by a survey administered immediately after the OGTT. We planned to enroll 100 participants in each group to detect an absolute difference of 20 percentage points or more on the 1-hour OGTT screen-positive rate using Fisher exact test, assuming an estimated screen-positive rate of 45% in the fasting and 25% in the fed group and 10% attrition, with a two-sided alpha=0.05, power=0.8. The primary outcome was the 1-hour OGTT screen-positive rate. Secondary outcomes included mean 1-hour OGTT glucose values, GDM diagnosis, maternal and neonatal outcomes, and patient perceptions regarding the 1-hour OGTT.RESULTS: From November 2020 through April 2021, 200 participants were randomized. One hundred ninety-five completed the 1-hour OGTT (97 fasting, 98 fed). Participant surveys confirmed 97.9% (n=95) adherence to the fasting and 91.8% (n=90) adherence to the fed groups. The screen-positive rate was significantly higher in the fasting than the fed group (32.0% vs 13.3%, respectively, P=.002), as was the mean glucose value (127.7 mg/dL vs 113.3 mg/dL, P=.002). The incidence of GDM in the fasting group was 12.4% (n=12) and in the fed group was 5.1% (n=5) (P=.08). There were no significant differences in maternal or neonatal outcomes.CONCLUSION: Fasting for 6 or more hours doubled the incidence of a positive 1-hour OGTT result when compared with eating within 2 hours of the test.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04547023.

  View details for DOI 10.1097/AOG.0000000000005013

  View details for PubMedID 36701613

• Abortion restriction impact on burden of neonatal single ventricle congenital heart disease: a decision-analytic model Miller, H. E., Henkel, A., Zhang, J., Leonard, S. A., Quirin, A. P., Maskatia, S. A., El Sayed, Y. Y., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2023: S483

  View details for Web of Science ID 000909337401304

• Severe maternal morbidity among people with cardiac disease: getting to the heart of the problem Darmawan, K. F., Panelli, D. M., Mayo, J. A., Leonard, S. A., Girsen, A., Carmichael, S. L., Bianco, K. MOSBY-ELSEVIER. 2023: S163-S164

  View details for Web of Science ID 000909337400236

• Increased primary cesarean delivery rate among people with epilepsy: Risks, drivers and future directions Darmawan, K. F., Leonard, S. A., Meador, K., McElrath, T. F., Carmichael, S. L., Lyell, D. J., El-Sayed, Y. Y., Herrero, T., Druzin, M. L., Panelli, D. M. MOSBY-ELSEVIER. 2023: S162-S163

  View details for Web of Science ID 000909337400234

• A novel fetal MRI lung volume nomogram stratified by estimated fetal weight Gershnabel, S., Jayapal, P., Zalcman, M., Barth, R. A., Rubesova, E., Hintz, S., Zhang, J., Leonard, S. A., El-Sayed, Y. Y., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2023: S577

  View details for Web of Science ID 000909337401449

• Treatment for Mild Chronic Hypertension During Pregnancy OBSTETRICAL & GYNECOLOGICAL SURVEY Tita, A. T., Szychowski, J. M., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K., Haas, D. M., Plante, L., Metz, T., Casey, B., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Harper, L., Ambalavanan, N., Geller, N. L., Oparil, S., Cutter, G. R., Andrews, W. W., Chronic Hypertension Pregnancy 2022; 77 (11): 634-636

  View details for DOI 10.1097/01.ogx.0000899456.24100.71

  View details for Web of Science ID 000874079000004

• Postpartum Readmission for Hypertension After Discharge on Labetalol or Nifedipine. Obstetrics and gynecology Do, S. C., Leonard, S. A., Kan, P., Panelli, D. M., Girsen, A. I., Lyell, D. J., El-Sayed, Y. Y., Druzin, M. L., Herrero, T. 2022

  Abstract

  To assess whether readmission for hypertension by 6 weeks postpartum differed between patients discharged on nifedipine or labetalol.This cohort study included patients with delivery admissions from 2006 to 2017 who were discharged from the hospital on nifedipine or labetalol and were included in a large, national adjudicated claims database. We identified patients' discharge medication based on filled outpatient prescriptions. We compared rates of hospital readmission for hypertension between patients discharged postpartum on labetalol alone, nifedipine alone, or combined nifedipine and labetalol. Patients with chronic hypertension without superimposed preeclampsia were excluded. Comparisons based on medication were performed using logistic regression models with adjustment for prespecified confounders. Comparisons were also stratified by hypertensive disorder of pregnancy severity.Among 1,582,335 patients overall, 14,112 (0.89%) were discharged postpartum on labetalol, 9,001 (0.57%) on nifedipine, and 1,364 (0.09%) on both medications. Postpartum readmissions for hypertension were more frequent for patients discharged on labetalol compared with nifedipine (641 patients vs 185 patients, 4.5% vs 2.1%, adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85). Readmissions for hypertension were more frequent for patients discharged on labetalol compared with nifedipine for both mild (4.5% vs 2.7%, aOR 1.57, 95% CI 1.29-1.93) and severe hypertensive disorders of pregnancy (261 patients vs 72 patients, 5.7% vs 3.2%, aOR 1.63, 95% CI 1.43-1.85). Readmissions for hypertension were more frequent on combined nifedipine and labetalol compared with nifedipine (3.1% vs 2.1%), but the odds were lower after confounder adjustment (aOR 0.80, 95% CI 0.64-0.99).Postpartum discharge on labetalol was associated with increased risk of readmission for hypertension compared with discharge on nifedipine.

  View details for DOI 10.1097/AOG.0000000000004918

  View details for PubMedID 36075068

• The Association between Prenatal Nicotine Exposure and Offspring's Hearing Impairment. American journal of perinatology Cleary, E. M., Kniss, D. A., Fette, L. M., Hughes, B. L., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., Gyamfi-Bannerman, C., Varner, M. W., Goodnight, W. H., Tita, A. T., Swamy, G. K., Heyborne, K. D., Chien, E. K., Chauhan, S. P., El-Sayed, Y. Y., Casey, B. M., Parry, S., Simhan, H. N., Napolitano, P. G., Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units (MFMU) Network 2022

  Abstract

  OBJECTIVE: The objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction.PATIENTS AND METHODS: Secondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine >5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure (p<0.05) in univariate analysis.RESULTS: Of 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55-4.20), but the difference was not significantly different (adjusted odds ratio [aOR]=1.0, 95% CI 0.30-3.31). This association was similar when exposure was stratified as heavy (>100 ng/mL, aOR 0.72, 95% CI 0.15-3.51) or mild (5-100 ng/mL, aOR 1.28, 95% CI 0.33-4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude.CONCLUSION: In a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs.KEY POINTS: · Nicotine exposure was quantified from maternal urine.. · Nicotine exposure was identified in 30% of the cohort.. · Exposure was not associated with offspring hearing dysfunction..

  View details for DOI 10.1055/s-0042-1750407

  View details for PubMedID 36007918

• Treatment for Mild Chronic Hypertension During Pregnancy OBSTETRICAL & GYNECOLOGICAL SURVEY Tita, A. T., Szychowski, J. M., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K., Haas, D. M., Plante, L., Metz, T., Casey, B., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Harper, L., Ambalavanan, N., Geller, N. L., Oparil, S., Cutter, G. R., Andrews, W. W., Chronic Hypertension Pregnancy CHA 2022; 77 (8): 460-462

  View details for DOI 10.1097/01.ogx.0000852888.79526.c3

  View details for Web of Science ID 000832442600006

• Amniocentesis to diagnose congenital cytomegalovirus infection following maternal primary infection. American journal of obstetrics & gynecology MFM Dinsmoor, M. J., Fette, L. M., Hughes, B. L., Rouse, D. J., Saade, G. R., Reddy, U. M., Allard, D., Mallett, G., Thom, E. A., Gyamfi-Bannerman, C., Varner, M. W., Goodnight, W. H., Tita, A. T., Costantine, M. M., Swamy, G. K., Heyborne, K. D., Chien, E. K., Chauhan, S. P., El-Sayed, Y. Y., Casey, B. M., Parry, S., Simhan, H. N., Napolitano, P. G., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network 2022: 100641

  Abstract

  Background Congenital cytomegalovirus infection following maternal primary cytomegalovirus infection affects approximately 0.4% of newborns in the United States but may be hard to diagnose prenatally. Objective To evaluate the current sensitivity and specificity of amniocentesis in detecting congenital CMV infection. Study Design Secondary analysis of a multicenter randomized placebo-controlled trial designed to evaluate whether CMV hyperimmune globulin (HIG) reduces congenital CMV in the neonates of individuals diagnosed with primary CMV infection prior to 24 weeks of gestation. At randomization, subjects had no clinical evidence of fetal infection. Eligible subjects were randomized to monthly infusions of CMV HIG or placebo until delivery. Although not required by the trial protocol, amniocentesis following randomization was permitted. The fetuses and neonates were tested for the presence of CMV at delivery. Comparisons were made between those with or without amniocentesis and between those with a CMV-positive or negative result, using chi-square test or Fisher's exact test for categorical variables and the Wilcoxon rank sum test or t-test for continuous variables. A P-value of < 0.05 was considered significant. Results From 2012-2018, 397 subjects were included, of whom 55 (14%) underwent amniocentesis. CMV results were available for 53 fetuses and neonates. Fourteen amniocenteses were positive (25%). The gestational age at amniocentesis was similar between those with and without CMV present, as was the interval between maternal diagnosis and amniocentesis. The prevalence of fetal or neonatal infection was 26% (14/53). The neonates of all 12 subjects with a positive amniocentesis and available results had CMV infection confirmed at delivery, as did 2 of the 41 subjects with a negative amniocentesis, for a sensitivity of 86% (95%CI 57-98%), specificity of 100% (95%CI 91-100%), positive predictive value of 100% (95%CI 74-100%) and negative predictive value of 95% (95%CI 83-99%). Amniocentesis-positive pregnancies delivered at an earlier gestational age (37.4 vs 39.6 weeks, P <0.001) and had a lower birthweight (2583 ± 749 vs 3428 ± 608 grams, P=0.004) than amniocentesis-negative pregnancies. Conclusion Amniocentesis results are an accurate predictor of congenital CMV infection.

  View details for DOI 10.1016/j.ajogmf.2022.100641

  View details for PubMedID 35526782

• Association of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation. Obstetrics and gynecology Costantine, M. M., Sandoval, G. J., Grobman, W. A., Reddy, U. M., Tita, A. T., Silver, R. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N. 2022; 139 (5): 866-876

  Abstract

  To compare health care medical resource utilization in low-risk nulliparous pregnancies according to body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) categories.This is a secondary analysis of a multicenter randomized controlled trial of induction of labor between 39 0/7 39 and 4/7 weeks of gestation compared with expectant management in low-risk nulliparous pregnant people, defined as those without standard obstetric indications for delivery at 39 weeks. Body mass index at randomization was categorized into four groups (lower than 25, 25-29, 30-39, and 40 or higher). The primary outcome of this analysis was time spent in the labor and delivery department from admission to delivery. Secondary outcomes included length of stay (LOS) postdelivery, total hospital LOS, and antepartum, intrapartum, and postpartum resource utilization, which were defined a priori. Multivariable generalized linear modeling and logistic regressions were performed, and 99% CIs were calculated.A total of 6,058 pregnant people were included in the analysis; 640 (10.6%) had BMIs of lower than 25, 2,222 (36.7%) had BMIs between 25 and 29, 2,577 (42.5%) had BMIs of 30-39, and 619 (10.2%) had BMIs of 40 or higher. Time spent in the labor and delivery department increased from 15.1±9.2 hours for people with BMIs of lower than 25 to 23.5±13.6 hours for people with BMIs of 40 or higher, and every 5-unit increase in BMI was associated with an average 9.8% increase in time spent in the labor and delivery department (adjusted estimate per 5-unit increase in BMI 1.10, 99% CI 1.08-1.11). Increasing BMI was not associated with an increase in antepartum resource utilization, except for blood tests and urinalysis. However, increasing BMI was associated with higher odds of intrapartum resource utilization, longer total hospital LOS, and postpartum resource utilization. For example, every 5-unit increase in BMI was associated with an increase of 26.1% in the odds of antibiotic administration, 57.6% in placement of intrauterine pressure catheter, 5.1% in total inpatient LOS, 31.0 in postpartum emergency department visit, and 23.9% in postpartum hospital admission.Among low-risk nulliparous people, higher BMI was associated with longer time from admission to delivery, total hospital LOS, and more frequent utilization of intrapartum and postpartum resources.ClinicalTrials.gov, NCT01990612.

  View details for DOI 10.1097/AOG.0000000000004753

  View details for PubMedID 35576345

• Maternal diabetes and intrapartum fetal electrocardiogram. American journal of perinatology Plunkett, B. A., Weiner, S., Saade, G., Belfort, M., Blackwell, S. C., Thorp, J. M., Tita, A., Miller, R. S., McKenna, D. S., Chien, E., Rouse, D. J., El-Sayed, Y., Sorokin, Y., Caritis, S. N. 2022

  Abstract

  OBJECTIVE: Fetal electrocardiogram (ECG) ST-changes are associated with fetal cardiac hypoxia. Our objective was to evaluate ST-changes by maternal diabetic status and stage of labor.METHODS: Secondary analysis of a multi-centered randomized-controlled trial in which laboring patients with singleton gestations underwent fetal ECG scalp electrode placement and were randomly assigned to masked or unmasked ST-segment readings. Our primary outcome was the frequency of fetal ECG tracings with ST-changes by stage of labor. ECG tracings were categorized into mutually exclusive groups (ST-depression, ST-elevation without ST-depression or no ST-changes). We compared participants with pre-gestational diabetes mellitus (DM), gestational DM (GDM), and no DM.RESULTS: Of the 5,436 eligible individuals in the first stage of labor (95 with pre-gestational DM and 370 with GDM) 4,427 progressed to the second stage. ST-depression occurred more frequently in the first stage of labor in participants with pre-gestational DM (15%, aOR 2.20, 95% CI 1.14-4.24) and with GDM (9.5%, aOR 1.51, 95% CI 1.02-2.25) as compared with participants without DM (5.7%). The frequency of ST-elevation was similar in participants with pregestational DM (33%, aOR 0.79, 95% CI 0.48-1.30) and GDM (33.2%, aOR 0.91, 95% CI 0.71-1.17) as compared with those without DM (34.2%). In the second stage, ST-depression did not occur in participants with pre-gestational DM (0%) and occurred more frequently in participants with GDM (3.5%, aOR 2.01, 95% CI 1.02-3.98) as compared with those without DM (2.0%). ST-elevation occurred more frequently in participants with pregestational DM (30%, aOR 1.81, 95% CI 1.02-3.22) but not with GDM (19.0%, aOR 1.06, 95% CI 0.77-1.47) as compared with those without DM (17.8%).CONCLUSION: ST-changes in fetal ECG occur more frequently in fetuses of diabetic mothers during labor.

  View details for DOI 10.1055/a-1817-5788

  View details for PubMedID 35381609

• Treatment for Mild Chronic Hypertension during Pregnancy. The New England journal of medicine Tita, A. T., Szychowski, J. M., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K., Haas, D. M., Plante, L., Metz, T., Casey, B., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Harper, L., Ambalavanan, N., Geller, N. L., Oparil, S., Cutter, G. R., Andrews, W. W., Chronic Hypertension and Pregnancy (CHAP) Trial Consortium 2022

  Abstract

  BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth.RESULTS: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 0.82 to 1.31; P=0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99).CONCLUSIONS: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).

  View details for DOI 10.1056/NEJMoa2201295

  View details for PubMedID 35363951

• Virtual reality experience for in utero fetal surgery: a new era of patient counselling and medical education BMJ INNOVATIONS Blumenfeld, Y. J., Axelrod, D. M., Sarno, D., Hintz, S. R., Sylvester, K. G., Grant, G. A., Belfort, M. A., Shamshirsaz, A. A., El-Sayed, Y. Y. 2022; 8 (2): 95-97

  View details for DOI 10.1136/bmjinnov-2021-000799

  View details for Web of Science ID 000823101300005

• Clinical and Hospital Factors Associated with Increased Cesarean Birth Rate Among People with Epilepsy Darmawan, K., Cruz, G., Leonard, S., Meador, K., McElrath, T., Carmichael, S., Lyell, D., El Sayed, Y., Herrero, T., Druzin, M., Panelli, D. SPRINGER HEIDELBERG. 2022: 216

  View details for Web of Science ID 000762765300443

• Noninvasive Prediction of Congenital Cytomegalovirus Infection After Maternal Primary Infection. Obstetrics and gynecology Rouse, D. J., Fette, L. M., Hughes, B. L., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., Pass, R., Allard, D., Mallett, G., Clifton, R. G., Saccoccio, F. M., Permar, S. R., Gyamfi-Bannerman, C., Varner, M. W., Goodnight, W. H., Tita, A. T., Costantine, M. M., Swamy, G. K., Heyborne, K. D., Chien, E. K., Chauhan, S. P., El-Sayed, Y. Y., Casey, B. M., Parry, S., Simhan, H. N., Napolitano, P. G., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 1800

  Abstract

  OBJECTIVE: To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.METHODS: We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation).RESULTS: Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53-0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02-0.07).CONCLUSION: We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making.

  View details for DOI 10.1097/AOG.0000000000004691

  View details for PubMedID 35115450

• Fasting vs fed: A randomized trial assessing oral intake prior to the glucose tolerance test Sperling, M., Leonard, S. A., Miller, S. E., El Sayed, Y. Y., Herrero, T., Faig, J., Carter, S., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2022: S189

  View details for Web of Science ID 000737459400263

• A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection OBSTETRICAL & GYNECOLOGICAL SURVEY Hughes, B. L., Clifton, R. G., Rouse, D. J., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., Pass, R., Allard, D., Mallett, G., Fette, L. M., Gyamfi-Bannerman, C., Varner, M. W., Goodnight, W. H., Tita, A. N., Costantine, M. M., Swamy, G. K., Gibbs, R. S., Chien, E. K., Chauhan, S. P., El-Sayed, Y. Y., Casey, B. M., Parry, S., Simhan, H. N., Napolitano, P. G., Macones, G. A., Eunice Kennedy Shriver Natl Inst C 2022; 77 (1): 16-18

  View details for Web of Science ID 000739995400008

• MFMU TOLAC Calculator: Does knowledge of a predicted success score increase VBAC rates? Gunaseelan, A., Cruz, G., El-Sayed, Y. Y., Johnson, C., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2022: S775

  View details for Web of Science ID 000737459401577

• Comparison between the old and new MFMU TOLAC Calculator - Which is more accurate? Gunaseelan, A., Cruz, G., El-Sayed, Y. Y., Johnson, C., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2022: S394

  View details for Web of Science ID 000737459400591

• Does magnesium sulfate for hypertensive disease reduce the risk of neonatal hypoxic ischemic encephalopathy? Minor, K. C., Liu, J., El-Sayed, Y. Y., Druzin, M. L., Profit, J., Hintz, S., Bonifacio, S., Leonard, S. A., Karakash, S. MOSBY-ELSEVIER. 2022: S526

  View details for Web of Science ID 000737459401175

• Hypoxic ischemic encephalopathy: Do peripartum risk factors account for observed changes in incidence? Minor, K. C., Liu, J., El-Sayed, Y. Y., Druzin, M. L., Profit, J., Hintz, S., Bonifacio, S., Karakash, S. MOSBY-ELSEVIER. 2022: S210

  View details for Web of Science ID 000737459400295

• Patient preferences, beliefs, and experiences regarding oral intake and the 1-hour oral glucose tolerance test Sperling, M., Leonard, S. A., Miller, S. E., El-Sayed, Y. Y., Herrero, T., Faig, J., Carter, S., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2022: S325-S326

  View details for Web of Science ID 000737459400479

• Ketonuria is associated with a positive 1-hour oral glucose tolerance test Sperling, M., Leonard, S. A., Miller, S. E., El-Sayed, Y. Y., Herrero, T., Faig, J., Carter, S., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2022: S574-S575

  View details for Web of Science ID 000737459401259

• Hypertension in pregnancy and adverse outcomes among low-risk nulliparous people expectantly managed at or after 39 weeks: a secondary analysis of a randomized controlled trial. BJOG : an international journal of obstetrics and gynaecology Fishel Bartal, M., Premkumar, A., Rice, M. M., Reddy, U. M., Tita, A. T., Silver, R. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Costantine, M. M., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Eunice Kennedy Shriver National Institute of Child Health, H. D. 1800

  Abstract

  OBJECTIVE: To evaluate whether hypertensive disorders of pregnancy (HDP) among low-risk nulliparous people expectantly managed (EM) at or after 39 weeks of gestation are associated with adverse outcomes.DESIGN: Secondary analysis of a randomized trial.SETTING: Multicenter United States.POPULATION: Individuals in the EM group who delivered on or after 39 weeks.METHODS: Multivariable analysis to estimate adjusted relative risks (aRR) for binomial outcomes, adjusted odds ratios (aOR) for multinomial outcomes, and 95% confidence intervals (CI).MAIN OUTCOME MEASURES: Composite adverse maternal outcome including placental abruption, pulmonary edema, postpartum hemorrhage, postpartum infection, venous thromboembolism, or intensive care unit admission. Secondary outcomes included a composite of perinatal death or severe neonatal complications, mode of delivery, small and large for gestational age, and neonatal intermediate or intensive unit length of stay.RESULTS: Of the 3,044 randomized to EM in the original trial, 2,718 (89.3%) were eligible for this analysis, of whom 373 (13.7%) developed HDP. Compared with participants who remained normotensive, those who developed HDP were more likely to experience the maternal composite (12% vs. 6%, aRR 1.84, 95% CI 1.33-2.54) and cesarean delivery (29% vs. 23%, aOR 1.32, 95% CI 1.01-1.71). Differences between the two groups were not significantly different for the adverse perinatal composite (7% vs. 5%, aRR 1.38, 95% CI 0.92-2.07), or other secondary outcomes.CONCLUSION: Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed HDP, and were more likely to experience adverse maternal outcomes compared with those who did not develop HDP.

  View details for DOI 10.1111/1471-0528.17059

  View details for PubMedID 34927787

• Racial and Ethnic Inequities in Cesarean Birth and Maternal Morbidity in a Low-Risk, Nulliparous Cohort. Obstetrics and gynecology Debbink, M. P., Ugwu, L. G., Grobman, W. A., Reddy, U. M., Tita, A. T., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Costantine, M. M., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 2021

  Abstract

  OBJECTIVE: To evaluate race and ethnicity differences in cesarean birth and maternal morbidity in low-risk nulliparous people at term.METHODS: We conducted a secondary analysis of a randomized trial of expectant management compared with induction of labor in low-risk nulliparous people at term. The primary outcome was cesarean birth. Secondary outcome was maternal morbidity, defined as: transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death. Multivariable modified Poisson regression was used to evaluate associations between race and ethnicity, cesarean birth, and maternal morbidity. Indication for cesarean birth was assessed using multivariable multinomial logistic regression. A mediation model was used to estimate the portion of maternal morbidity attributable to cesarean birth by race and ethnicity.RESULTS: Of 5,759 included participants, 1,158 (20.1%) underwent cesarean birth; 1,404 (24.3%) identified as non-Hispanic Black, 1,670 (29.0%) as Hispanic, and 2,685 (46.6%) as non-Hispanic White. Adjusted models showed increased relative risk of cesarean birth among non-Hispanic Black (adjusted relative risk [aRR] 1.21, 95% CI 1.03-1.42) and Hispanic (aRR 1.26, 95% CI 1.08-1.46) people compared with non-Hispanic White people. Maternal morbidity affected 132 (2.3%) individuals, and was increased among non-Hispanic Black (aRR 2.05, 95% CI 1.21-3.47) and Hispanic (aRR 1.92, 95% CI 1.17-3.14) people compared with non-Hispanic White people. Cesarean birth accounted for an estimated 15.8% (95% CI 2.1-48.7%) and 16.5% (95% CI 4.0-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.CONCLUSION: Non-Hispanic Black and Hispanic nulliparous people who are low-risk at term undergo cesarean birth more frequently than low-risk non-Hispanic White nulliparous people. This difference accounts for a modest portion of excess maternal morbidity.

  View details for DOI 10.1097/AOG.0000000000004620

  View details for PubMedID 34856577

• Association of Epilepsy and Severe Maternal Morbidity. Obstetrics and gynecology Panelli, D. M., Leonard, S. A., Kan, P., Meador, K. J., McElrath, T. F., Darmawan, K. F., Carmichael, S. L., Lyell, D. J., El-Sayed, Y. Y., Druzin, M. L., Herrero, T. C. 2021

  Abstract

  OBJECTIVE: To evaluate severe maternal morbidity (SMM) among patients with epilepsy and patients without epilepsy.METHODS: We retrospectively examined SMM using linked birth certificate and maternal hospital discharge records in California between 2007 and 2012. Epilepsy present at delivery admission was the exposure and was subtyped into generalized, focal and other less specified, or unspecified. The outcomes were SMM and nontransfusion SMM from delivery up to 42 days' postpartum, identified using Centers for Disease Control and Prevention indicators. Multivariable logistic regression models were used to adjust for confounders, which were selected a priori. We also estimated the association between epilepsy and SMM independent of comorbidities by using a validated obstetric comorbidity score. Severe maternal morbidity indicators were then compared using the same multivariable logistic regression models.RESULTS: Of 2,668,442 births, 8,145 (0.3%) were to patients with epilepsy; 637 (7.8%) had generalized, 6,250 (76.7%) had focal or other less specified, and 1,258 (15.4%) had unspecified subtypes. Compared with patients without epilepsy, patients with epilepsy had greater odds of SMM (4.3% vs 1.4%, adjusted odds ratio [aOR] 2.91, 95% CI 2.61-3.24) and nontransfusion SMM (2.9% vs 0.7%, aOR 4.16, 95% CI 3.65-4.75). Epilepsy remained significantly associated with increased SMM and nontransfusion SMM after additional adjustment for the obstetric comorbidity score, though the effects were attenuated. When grouped by organ system, all SMM indicators were significantly more common among patients with epilepsy-most notably those related to hemorrhage and transfusion.CONCLUSION: Severe maternal morbidity was significantly increased in patients with epilepsy, and SMM indicators across all organ systems contributed to this.

  View details for DOI 10.1097/AOG.0000000000004562

  View details for PubMedID 34619720

• Homelessness in pregnancy: perinatal outcomes. Journal of perinatology : official journal of the California Perinatal Association St Martin, B. S., Spiegel, A. M., Sie, L., Leonard, S. A., Seidman, D., Girsen, A. I., Shaw, G. M., El-Sayed, Y. Y. 2021

  Abstract

  OBJECTIVE: Investigate the association between maternal homelessness at the time of delivery and perinatal outcomes, with a focus on neonatal health outcomes.STUDY DESIGN: Population-based cohort using California's statewide database included 1,520,253 women with linked birth and maternal discharge data, 2008-2012. Multivariable analysis assessed homelessness at time of delivery on perinatal outcomes, preterm delivery, and neonatal intensive care unit admission.RESULT: A total of 672 women (0.05%) were homeless at the time of delivery. Homelessness was associated with premature delivery at multiple gestational age cutoffs (34w0d-36w6d; 32w0d-33w6d; 28w0d-31w6d; <28w0d) (range of aORs:1.62-2.19), and neonatal intensive care unit admission (aOR=1.66, 95% CI:1.31-2.09). Among term infants, homelessness remained associated with increased odds of neonatal intensive care unit admission (aOR=1.84, 95% CI:1.34-2.53), low birthweight (aOR=1.99, 95% CI:1.36-2.90), neonatal abstinence syndrome (aOR=2.13, 95% CI:1.35-2.53), hypoxic-ischemic encephalopathy (aOR=14.38, 95% CI:3.90-53.01), and necrotizing enterocolitis (aOR=14.94, 95% CI:2.68-83.20).CONCLUSION: Homelessness in pregnancy was associated with adverse perinatal outcomes including increased odds of preterm delivery across all gestational ages, and increased risk of neonatal intensive care unit admission and low birth weight independent of preterm delivery.

  View details for DOI 10.1038/s41372-021-01187-3

  View details for PubMedID 34404925

• Intrapartum Resuscitation Interventions for Category II Fetal Heart Rate Tracings and Improvement to Category I. Obstetrics and gynecology Reddy, U. M., Weiner, S. J., Saade, G. R., Varner, M. W., Blackwell, S. C., Thorp, J. M., Tita, A. T., Miller, R. S., Peaceman, A. M., McKenna, D. S., Chien, E. K., Rouse, D. J., El-Sayed, Y. Y., Sorokin, Y., Caritis, S. N., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 2021

  Abstract

  OBJECTIVE: To evaluate intrapartum resuscitation interventions and improvement in category II fetal heart rate (FHR) tracings.METHODS: This secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis included all participants with category II FHR tracings undergoing intrauterine resuscitation: maternal oxygen, intravenous fluid bolus, amnioinfusion, or tocolytic administration. Fetal heart rate pattern-recognition software was used to confirm category II FHR tracings 30 minutes before intervention and to analyze the subsequent 60 minutes. The primary outcome was improvement to category I within 60 minutes. Secondary outcomes included FHR tracing improvement to category I 30-60 minutes after the intervention and composite neonatal outcome.RESULTS: Of 11,108 randomized participants, 2,251 (20.3%) had at least one qualifying intervention for category II FHR tracings: 63.7% improved to category I within 60 minutes and 50.5% improved at 30-60 minutes. Only 3.4% underwent cesarean delivery and 4.1% an operative vaginal delivery for nonreassuring fetal status within 60 minutes after the intervention. Oxygen administration was the most common intervention (75.4%). Among American College of Obstetricians and Gynecologists-defined subgroups that received oxygen, the absent FHR accelerations and absent-minimal FHR variability subgroup (n=332) was more likely to convert to category I within 60 minutes than the FHR accelerations or "moderate FHR variability" subgroup (n=1,919) (77.0% vs 63.0%, odds ratio [OR] 2.0, 95% CI 1.4-2.7). The incidence of composite neonatal adverse outcome for category II tracings was 2.9% (95% CI 2.2-3.7%) overall; 2.8% (95% CI 2.0-3.8%) for improvement to category I within 60 minutes (n=1,433); and 3.2% (95% CI 2.1-4.6%) for no improvement within 60 minutes (n=818). However, the group with improvement had 29% lower odds for higher level neonatal care (11.8% vs 15.9%, OR 0.71, 95% CI 0.55-0.91).CONCLUSION: Nearly two thirds of category II FHR tracings improved to category I within 60 minutes of intervention with a relatively low overall rate of the composite neonatal adverse outcome.FUNDING SOURCE: Funded in part by Neoventa Medical.

  View details for DOI 10.1097/AOG.0000000000004508

  View details for PubMedID 34352857

• Maternal and Neonatal Outcomes in Nulliparous Participants Undergoing Labor Induction by Cervical Ripening Method. American journal of perinatology Andrikopoulou, M., Bushman, E. T., Rice, M. M., Grobman, W. A., Reddy, U. M., Silver, R. M., El-Sayed, Y. Y., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Costantine, M. M., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Eunice Kennedy Shriver National Institute of Child Health Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 2021

  Abstract

  OBJECTIVE: This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.STUDY DESIGN: This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics.RESULTS: Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR]=1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR=1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR=1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR=0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR=0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR=0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference=-1.97hours, 95% CI: -3.45 to -0.49 and -5.92hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE.CONCLUSION: In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin.KEY POINTS: · Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial..

  View details for DOI 10.1055/s-0041-1732379

  View details for PubMedID 34352922

• Trends in Spontaneous and Medically Indicated Preterm Birth in Twins versus Singletons: A California Cohort 2007 to 2011. American journal of perinatology Ness, A., Mayo, J. A., El-Sayed, Y. Y., Druzin, M. L., Stevenson, D. K., Shaw, G. M. 2021

  Abstract

  OBJECTIVE: The study aimed to describe preterm birth (PTB) rates, subtypes, and risk factors in twins compared with singletons to better understand reasons for the decline in PTB rate between 2007 and 2011.STUDY DESIGN: This was a retrospective population-based analysis using the California linked birth certificates and maternal-infant hospital discharge records from 2007 to 2011. The main outcomes were overall, spontaneous (following spontaneous labor or preterm premature rupture of membranes), and medically indicated PTB at various gestational age categories: <37, <32, and 34 to 36 weeks in twins and singletons.RESULTS: Among the 2,290,973 singletons and 28,937 twin live births pairs included, overall PTB <37 weeks decreased by 8.46% (6.77-6.20%) in singletons and 7.17% (55.31-51.35%) in twins during the study period. In singletons, this was primarily due to a 24.91% decrease in medically indicated PTB with almost no change in spontaneous PTB, whereas in twins indicated PTB declined 7.02% and spontaneous PTB by 7.39%.CONCLUSION: Recent declines in PTB in singletons appear to be largely due to declines in indicated PTB, whereas both spontaneous and indicated PTB declined in twins.KEY POINTS: · The declines in PTB noted between 2006 and 2014 occurred in both singleton and twins.. · Declines were mostly in medically indicated PTB.. · Interventions proposed as causing the declines in singletons would not apply to twins..

  View details for DOI 10.1055/s-0041-1729161

  View details for PubMedID 33934321

• Risk Factors for Postpartum Readmission Among Women After Having a Stillbirth. American journal of obstetrics & gynecology MFM DiTosto, J. D., Liu, C., Wall-Wieler, E., Gibbs, R. S., Girsen, A. I., El-Sayed, Y. Y., Butwick, A. J., Carmichael, S. L. 2021: 100345

  Abstract

  BACKGROUND: Compared to women with a livebirth, women with a stillbirth are more likely to have maternal complications during pregnancy and at birth, but risk factors related to their postpartum health are uncertain.OBJECTIVE: This study aimed to identify patient-level risk factors for postpartum hospital readmission among women after having a stillbirth.STUDY DESIGN: This is a population-based cohort study of 29,654 women with a stillbirth in California from 1997-2011. Using logistic regression models, we examined the association of maternal patient-level factors with postpartum readmission among women after a stillbirth within six weeks of hospital discharge and between six weeks and nine months after birth.RESULTS: Within six weeks after a stillbirth, 642 (2.2%) women had a postpartum readmission. Risk factors for postpartum readmission after a stillbirth were: severe maternal morbidity excluding transfusion (aOR= 3.02, 95% CI 2.28-4.00), transfusion at delivery but no other indication of severe maternal morbidity (aOR= 1.95, 95% CI 1.35-2.81), gestational hypertension or preeclampsia (aOR=1.93, 95% CI 1.54-2.42), pre-pregnancy hypertension (aOR= 1.80, 95% CI 1.36-2.37), diabetes (aOR= 1.78, 95% CI = 1.33-2.37), an antenatal hospitalization (aOR= 1.78, 95% CI 1.43-2.21), cesarean birth (aOR= 1.73, 95% CI 1.43-2.21), long (> 2 days for vaginal birth, > 4 days for cesarean birth) birth hospitalization length of stay (aOR= 1.59, 95% CI 1.33-1.89), non- Hispanic black race/ ethnicity (aOR= 1.38, 95% CI 1.08-1.76), and having less than a high school education (aOR= 1.35, 95% CI 1.02-1.80). From 6 weeks to 9 months, 1,169 (3.90%) women had a postpartum readmission; significantly associated risk factors were largely similar to those for earlier readmission.CONCLUSION: Women with comorbidities, birth-related complications, of non-Hispanic black race/ ethnicity, or with less education had increased odds of postpartum readmission after having a stillbirth, highlighting the importance of continued care for these women after birth hospitalization.TRIAL REGISTRATION: Not applicable.

  View details for DOI 10.1016/j.ajogmf.2021.100345

  View details for PubMedID 33705999

• To pull or not to pull: clinical factors associated with failed operative vaginal delivery Panelli, D. M., Leonard, S. A., Joudi, N., Girsen, A., Judy, A., Bianco, K., El-Sayed, Y. Y., Gilbert, W., Lyell, D. J. MOSBY-ELSEVIER. 2021: S101

  View details for Web of Science ID 000621547400148

• Intrapartum Fetal Electrocardiogram in Small- and Large-for-Gestational Age Fetuses. American journal of perinatology Braginsky, L., Weiner, S. J., Saade, G. R., Varner, M. W., Blackwell, S. C., Reddy, U. M., Thorp, J. M., Tita, A. T., Miller, R. S., McKenna, D. S., Chien, E. K., Rouse, D. J., El-Sayed, Y. Y., Sorokin, Y., Caritis, S. N. 2021

  Abstract

   This study aimed to evaluate whether intrapartum fetal electrocardiogram (ECG) tracings with ST-elevation or depression occur more frequently in each stage of labor in small-for-gestational age (SGA) or large-for-gestational age (LGA), as compared with appropriate-for-gestational age (AGA) fetuses. We conducted a secondary analysis of a large, multicenter trial in which laboring patients underwent fetal ECG waveform-analysis. We excluded participants with diabetes mellitus and major fetal anomalies. Birth weight was categorized as SGA (<10th percentile), LGA (>90th percentile), or AGA (10-90th percentile) by using a gender and race/ethnicity specific nomogram. In adjusted analyses, the frequency of ECG tracings with ST-depression or ST-elevation without depression was compared according to birthweight categories and labor stage. Our study included 4,971 laboring patients in the first stage and 4,074 in the second stage. During the first stage of labor, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (6.7 vs. 5.5%; adjusted odds ratio [aOR]: 1.41, 95% confidence interval [CI]: 0.93-2.13), or in ST-elevation without depression (35.8 vs. 34.1%; aOR: 1.17, 95% CI: 0.94-1.46). During the second stage, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (1.6 vs. 2.0%; aOR: 0.69, 95% CI: 0.27-1.73), or in ST-elevation without depression (16.2 vs. 18.1%; aOR: 0.90, 95% CI: 0.67-1.22). During the first stage of labor, there were no differences in the frequency of ST-depression in LGA fetuses compared with AGA fetuses (6.3 vs. 5.5%; aOR: 0.97, 95% CI: 0.60-1.57), or in ST-elevation without depression (33.1 vs. 34.1%; aOR: 0.80, 95% CI: 0.62-1.03); during the second stage of labor, the frequency of ST-depression in LGA compared with AGA fetuses (2.5 vs. 2.0%, aOR: 1.36, 95% CI: 0.61-3.03), and in ST-elevation without depression (15.5 vs. 18.1%; aOR: 0.83, 95% CI: 0.58-1.18) were similar as well. The frequency of intrapartum fetal ECG tracings with ST-events is similar among SGA, AGA, and LGA fetuses.· SGA and LGA neonates are at increased risk of cardiac dysfunction.. · Fetal ECG has been used to evaluate fetal response to hypoxia.. · Fetal ST-elevation and ST-depression occur during hypoxia.. · Frequency of intrapartum ST-events is similar among SGA, AGA and LGA fetuses..

  View details for DOI 10.1055/s-0041-1735285

  View details for PubMedID 34464982

• Individualized growth assessment in pregnancies complicated by fetal gastroschisis. The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians Sherwin, E., Deter, R., Joudi, N., Trepman, P., Lee, W., El-Sayed, Y. Y., Girsen, A. I., Datoc, I., Hintz, S. R., Blumenfeld, Y. J. 2021: 1-11

  Abstract

  Prenatal ultrasound (US) has been shown to overestimate the incidence of suspected fetal growth restriction (FGR) in gastroschisis cases. This is largely because of altered sonographic abdominal circumference (AC) measurements when comparing gastroschisis cases with population nomograms. Individualized Growth Assessment (IGA) evaluates fetal growth using serial US measurements that allow consideration of the growth potential for a given case. Our goal was to assess the utility of IGA for distinguishing normal and pathological fetal growth in gastroschisis cases.Pregnancies with prenatally diagnosed fetal gastroschisis were managed and delivered at a single academic medical center. US fetal biometry including head circumference (HC), abdominal circumference (AC), and femur diaphysis length (FDL), and neonatal measurements including birthweight and HC were collected and analyzed for 32 consecutive fetal gastroschisis cases with at least two 2nd and two 3rd trimester measurements. Second trimester growth velocities were compared to a group of 118 non-anomalous fetuses with normal neonatal growth outcomes. Gastroschisis cases were classified into groups based on fetal growth pathology score (FGPS9) patterns. Agreement between IGA (FGPS9) and serial conventional estimated fetal weight (EFW) measurements for determining growth pathology was evaluated. Neonatal size outcomes were compared between conventional birthweight classifications for determining small for gestational age (SGA) and IGA Growth Potential Realization Index (GPRI) for weight and head circumference measurements.Fetal growth pathology score (FGPS9) measurements identified three in-utero growth patterns: no growth pathology, growth restriction and recovery, and progressive growth restriction. In the no growth pathology group (n = 19), there was 84% agreement between IGA and conventional methods in determining pathological growth in both the 3rd trimester and at birth. In the growth restriction and recovery group (n = 7), there was 71% agreement both in the 3rd trimester and at birth between IGA and conventional methods. In the progressive growth restriction group (n = 5), there was 100% agreement in the 3rd trimester and 60% agreement at birth between IGA and conventional methods.We present the first study using IGA to evaluate normal and pathological fetal growth in prenatally diagnosed gastroschisis cases. IGA was able to delineate two 3rd trimester growth pathology patterns - one with persistent growth restriction and another with in-utero growth recovery. Further validation of these initial findings with larger cohorts is warranted.

  View details for DOI 10.1080/14767058.2021.1926976

  View details for PubMedID 34098833

• A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection. The New England journal of medicine Hughes, B. L., Clifton, R. G., Rouse, D. J., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., Pass, R., Allard, D., Mallett, G., Fette, L. M., Gyamfi-Bannerman, C., Varner, M. W., Goodnight, W. H., Tita, A. T., Costantine, M. M., Swamy, G. K., Gibbs, R. S., Chien, E. K., Chauhan, S. P., El-Sayed, Y. Y., Casey, B. M., Parry, S., Simhan, H. N., Napolitano, P. G., Macones, G. A. 2021; 385 (5): 436-444

  Abstract

  Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae. There is no established intervention for preventing congenital CMV infection.In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks' gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin (at a dose of 100 mg per kilogram of body weight) or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed.From 2012 to 2018, a total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization. The trial was stopped early for futility. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women (22.7%) in the group that received hyperimmune globulin and of 37 of 191 women (19.4%) in the placebo group (relative risk, 1.17; 95% confidence interval [CI] 0.80 to 1.72; P = 0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth occurred in 12.2% and 8.3%, respectively (relative risk, 1.47; 95% CI, 0.81 to 2.67), and birth weight below the 5th percentile occurred in 10.3% and 5.4% (relative risk, 1.92; 95% CI, 0.92 to 3.99). One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion. Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo.Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks' gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences; ClinicalTrials.gov number, NCT01376778.).

  View details for DOI 10.1056/NEJMoa1913569

  View details for PubMedID 34320288

• Maternal and Perinatal Outcomes of Expectant Management of Full-Term, Low-Risk, Nulliparous Patients. Obstetrics and gynecology Tita, A. T., Doherty, L. n., Grobman, W. A., Reddy, U. M., Silver, R. M., Mallett, G. n., Rice, M. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Costantine, M. M., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A. 2021; Publish Ahead of Print

  Abstract

  To compare risks of maternal and perinatal outcomes by completed week of gestation from 39 weeks in low-risk nulliparous patients undergoing expectant management.We conducted a secondary analysis of a multicenter randomized trial of elective induction of labor at 39 weeks of gestation compared with expectant management in low-risk nulliparous patients. Participants with nonanomalous neonates, who were randomized to and underwent expectant management and attained 39 0/7 weeks of gestation, were included. Delivery gestation was categorized by completed week: 39 0/7-39 6/7 (39 weeks), 40 0/7-40 6/7 (40 weeks), and 41 0/7-42 2/7 (41-42 weeks) (none delivered after 42 2/7). The coprimary outcomes were cesarean delivery and a perinatal composite (death, respiratory support, 5-minute Apgar score 3 or less, hypoxic ischemic encephalopathy, seizure, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support). Other outcomes included a maternal composite (blood transfusion, surgical intervention for postpartum hemorrhage, or intensive care unit admission), hypertensive disorders of pregnancy, peripartum infection, and neonatal intermediate or intensive care unit admission. For multivariable analysis, P<.0125 was considered to indicate statistical significance for the coprimary outcomes.Of 2,502 participants who underwent expectant management, 964 (38.5%) delivered at 39 weeks of gestation, 1,111 (44.4%) at 40 weeks, and 427 (17.1%) at 41-42 weeks. The prevalence of medically indicated delivery was 37.9% overall and increased from 23.8% at 39 weeks of gestation to 80.3% at 41-42 weeks. The frequency of cesarean delivery (17.3%, 22.0%, 37.5%; P<.001) and the perinatal composite (5.1%, 5.9%, 8.2%; P=.03) increased with 39, 40, and 41-42 weeks of gestation, respectively, and hypertensive disorders of pregnancy decreased (16.4%, 12.1%, 10.8%, P=.001). The adjusted relative risk, 95% CI (39 weeks as referent) was significant for cesarean delivery at 41-42 weeks of gestation (1.93, 1.61-2.32) and for hypertensive disorders of pregnancy at 40 weeks (0.71, 0.58-0.88) and 41-42 weeks (0.61, 0.45-0.82). None of the other outcomes were significant.In expectantly managed low-risk nulliparous participants, the frequency of medically indicated induction of labor, and the risks of cesarean delivery but not the perinatal composite outcome, increased significantly from 39 to 42 weeks of gestation.

  View details for DOI 10.1097/AOG.0000000000004230

  View details for PubMedID 33416294

• Severe maternal and neonatal morbidity after attempted operative vaginal delivery. American journal of obstetrics & gynecology MFM Panelli, D. M., Leonard, S. A., Joudi, N. n., Girsen, A. I., Judy, A. E., El-Sayed, Y. Y., Gilbert, W. M., Lyell, D. J. 2021: 100339

  Abstract

  Operative vaginal delivery (OVD) is a critical tool in reducing primary cesarean birth, but declining OVD rates and concerns about provider skill necessitate a clear understanding of risks. These risks are ambiguous because most studies compare outcomes with OVD to spontaneous vaginal delivery, rather than to second stage cesarean which is usually the realistic alternative.Our objective was to compare severe maternal and neonatal morbidity by mode of delivery among patients with a prolonged second stage of labor who had a successful OVD, a cesarean birth after failed OVD, or a cesarean birth without an OVD attempt.We used a population-based database to evaluate nulliparous, term, singleton, vertex livebirths in California between 2007 and 2012 among patients with a prolonged second stage of labor. Birth certificate and ICD-9-CM coded diagnoses and procedures were used for ascertainment of exposure, outcome, and demographics. Exposure was mode of delivery among patients who had any OVD attempt versus cesarean without OVD attempt. The outcomes were severe maternal morbidity (SMM) and severe unexpected newborn morbidity (UNM), defined using established indices. Anticipating that the code for prolonged second stage of labor would represent only a fraction of true OVD candidates, a secondary analysis was conducted removing this restriction in order to explore granular outcomes in a larger cohort with unsuccessful labor. Multivariable logistic regression was used to compare outcomes by mode of delivery adjusted for measured confounders. Sensitivity analyses were done excluding patients with combined vacuum-forceps and birthweight >4000g.9,239 prolonged second stage births were included; 6,851 (74.1%) were successful OVDs, 301 (3.3%) were failed OVDs, and 2,087 (22.6%) were cesareans without OVD attempts. Of successful OVDs, 6,195 (90.4%) were vacuums and 656 (10.6%) were forceps. Of failed OVDs where OVD type was specified, 83 (47.4%) were vacuums, 38 (21.7%) were forceps, and 54 (30.9%) were combined vacuum-forceps. Of note, all 54 combined vacuum-forceps OVD attempts that we identified failed. Patients with failed OVD differed from those with successful OVD, with higher rates of comorbidities, use of combined OVD, and birthweight >4000 g. Successful OVD was associated with reduced SMM (aOR 0.55, 95% CI 0.39-0.78) without a difference in severe UNM (aOR 0.99, 95% CI 0.78-1.26). In contrast, failed OVD was associated with increased SMM (aOR 2.14, 95% CI 1.20-3.82) and severe UNM (aOR 1.78, 95% CI 1.09-2.86). Findings were similar in secondary analysis of 260,585 patients with unsuccessful labor.In this large cohort of nulliparous, term, singleton, vertex births, successful OVD was associated with a 45% reduction in SMM without differences in severe UNM when compared to cesarean birth after prolonged second stage of labor. OVD failed infrequently, but when it did it was associated with a 214% increase in SMM and a 78% increase in severe UNM; combined OVDs were major contributors to this, since all combined OVDs failed. Optimization of OVD success rates through means such as improved patient selection, enhanced provider skill, and dissuasion against combined OVD could reduce maternal and neonatal complications.

  View details for DOI 10.1016/j.ajogmf.2021.100339

  View details for PubMedID 33631384

• Proteomic signatures predict preeclampsia in individual cohorts but not across cohorts - implications for clinical biomarker studies. The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians Ghaemi, M. S., Tarca, A. L., Romero, R. n., Stanley, N. n., Fallahzadeh, R. n., Tanada, A. n., Culos, A. n., Ando, K. n., Han, X. n., Blumenfeld, Y. J., Druzin, M. L., El-Sayed, Y. Y., Gibbs, R. S., Winn, V. D., Contrepois, K. n., Ling, X. B., Wong, R. J., Shaw, G. M., Stevenson, D. K., Gaudilliere, B. n., Aghaeepour, N. n., Angst, M. S. 2021: 1–8

  Abstract

  Early identification of pregnant women at risk for preeclampsia (PE) is important, as it will enable targeted interventions ahead of clinical manifestations. The quantitative analyses of plasma proteins feature prominently among molecular approaches used for risk prediction. However, derivation of protein signatures of sufficient predictive power has been challenging. The recent availability of platforms simultaneously assessing over 1000 plasma proteins offers broad examinations of the plasma proteome, which may enable the extraction of proteomic signatures with improved prognostic performance in prenatal care.The primary aim of this study was to examine the generalizability of proteomic signatures predictive of PE in two cohorts of pregnant women whose plasma proteome was interrogated with the same highly multiplexed platform. Establishing generalizability, or lack thereof, is critical to devise strategies facilitating the development of clinically useful predictive tests. A second aim was to examine the generalizability of protein signatures predictive of gestational age (GA) in uncomplicated pregnancies in the same cohorts to contrast physiological and pathological pregnancy outcomes.Serial blood samples were collected during the first, second, and third trimesters in 18 women who developed PE and 18 women with uncomplicated pregnancies (Stanford cohort). The second cohort (Detroit), used for comparative analysis, consisted of 76 women with PE and 90 women with uncomplicated pregnancies. Multivariate analyses were applied to infer predictive and cohort-specific proteomic models, which were then tested in the alternate cohort. Gene ontology (GO) analysis was performed to identify biological processes that were over-represented among top-ranked proteins associated with PE.The model derived in the Stanford cohort was highly significant (p = 3.9E-15) and predictive (AUC = 0.96), but failed validation in the Detroit cohort (p = 9.7E-01, AUC = 0.50). Similarly, the model derived in the Detroit cohort was highly significant (p = 1.0E-21, AUC = 0.73), but failed validation in the Stanford cohort (p = 7.3E-02, AUC = 0.60). By contrast, proteomic models predicting GA were readily validated across the Stanford (p = 1.1E-454, R = 0.92) and Detroit cohorts (p = 1.1.E-92, R = 0.92) indicating that the proteomic assay performed well enough to infer a generalizable model across studied cohorts, which makes it less likely that technical aspects of the assay, including batch effects, accounted for observed differences.Results point to a broader issue relevant for proteomic and other omic discovery studies in patient cohorts suffering from a clinical syndrome, such as PE, driven by heterogeneous pathophysiologies. While novel technologies including highly multiplex proteomic arrays and adapted computational algorithms allow for novel discoveries for a particular study cohort, they may not readily generalize across cohorts. A likely reason is that the prevalence of pathophysiologic processes leading up to the "same" clinical syndrome can be distributed differently in different and smaller-sized cohorts. Signatures derived in individual cohorts may simply capture different facets of the spectrum of pathophysiologic processes driving a syndrome. Our findings have important implications for the design of omic studies of a syndrome like PE. They highlight the need for performing such studies in diverse and well-phenotyped patient populations that are large enough to characterize subsets of patients with shared pathophysiologies to then derive subset-specific signatures of sufficient predictive power.

  View details for DOI 10.1080/14767058.2021.1888915

  View details for PubMedID 33653202

• Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women. Obstetrics and gynecology El-Sayed, Y. Y., Rice, M. M., Grobman, W. A., Reddy, U. M., Tita, A. T., Silver, R. M., Mallett, G., Hill, K., Thom, E. A., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Chien, E. K., Casey, B. M., Gibbs, R. S., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network* 2020

  Abstract

  OBJECTIVE: To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.METHODS: We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.RESULTS: Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).CONCLUSION: Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.

  View details for DOI 10.1097/AOG.0000000000004055

  View details for PubMedID 32925628

• Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation. Obstetrics and gynecology Silver, R. M., Rice, M. M., Grobman, W. A., Reddy, U. M., Tita, A. T., Mallett, G., Hill, K., Thom, E. A., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Chien, E. K., Casey, B. M., Gibbs, R. S., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network* 2020

  Abstract

  OBJECTIVE: To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.METHODS: We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.RESULTS: Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.CONCLUSION: Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their "customized" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.

  View details for DOI 10.1097/AOG.0000000000004046

  View details for PubMedID 32925634

• Use of Remdesivir for Pregnant Patients with Severe Novel 2019 Coronavirus Disease. American journal of obstetrics and gynecology Igbinosa, I., Miller, S., Bianco, K., Nelson, J., Kappagoda, S., Blackburn, B. G., Grant, P., Subramanian, A., Lyell, D., El-Sayed, Y., Aziz, N. 2020

  View details for DOI 10.1016/j.ajog.2020.08.001

  View details for PubMedID 32771381

• Hepatitis C Virus Antibody Screening in a Cohort of Pregnant Women: Identifying Seroprevalence and Risk Factors. Obstetrics and gynecology Prasad, M., Saade, G. R., Sandoval, G., Hughes, B. L., Reddy, U. M., Mele, L., Salazar, A., Varner, M. W., Gyamfi-Bannerman, C., Thorp, J. M., Tita, A. T., Swamy, G. K., Chien, E. K., Casey, B. M., Peaceman, A. M., El-Sayed, Y. Y., Iams, J. D., Gibbs, R. S., Sibai, B., Wiese, N., Kamili, S., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 2020

  Abstract

  OBJECTIVE: To describe the prevalence of hepatitis C virus (HCV) antibody, evaluate current risk factors associated with HCV antibody positivity, and identify novel composite risk factors for identification of groups most likely to demonstrate HCV antibody seropositivity in an obstetric population from 2012 to 2015.METHODS: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network initiated an observational study of mother-to-child transmission of HCV in 2012 that included offering HCV antibody screening to their entire obstetric population. Women presenting for prenatal care before 23 weeks of gestation without a known multifetal gestation were eligible. For each woman who was HCV antibody-positive, two women at similar gestational age who were HCV antibody-negative were identified and included for comparison. Risk factors were evaluated by patient interview and chart review. Women in the case group were identified to have a signal-to-cutoff value of at least 5 on the Abbott ARCHITECT platform. RNA status was evaluated for women in the case group.RESULTS: Of 106,842 women screened for the HCV antibody, 254 had positive results. The HCV antibody seroprevalence rate was 2.4 cases per 1,000 women (95% CI 2.1-2.7). One hundred thirty-one women in the case group and 251 women in the control group were included in the case-control analysis. Factors associated with HCV antibody positivity included injection drug use (adjusted odds ratio [aOR] 22.9, 95% CI 8.2-64.0), blood transfusion (aOR 3.7, 95% CI 1.3-10.4), having a partner with HCV (aOR 6.3, 95% CI 1.8-22.6), more than three lifetime sexual partners (aOR 5.3, 95% CI 1.4-19.8), and smoking (aOR 2.4, 95% CI 1.2-4.6). A composite of any of these potential risk factors provided the highest sensitivity for detecting HCV antibody (75/82 cases, 91%).CONCLUSION: In this cohort, the seroprevalence of HCV antibody was low, and the current risk factors for HCV screening were not identified. These findings may be useful in defining new strategies for identifying mothers with the HCV antibody and the neonates susceptible to maternal transmission of HCV.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959321.

  View details for DOI 10.1097/AOG.0000000000003754

  View details for PubMedID 32168224

• Health resource utilization of labor induction versus expectant management: Resource utilization at induction of labor. American journal of obstetrics and gynecology Grobman, W. A., Sandoval, G., Reddy, U. M., Tita, A. T., Silver, R. M., Mallett, G., Hill, K., Rice, M. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Iams, J. D., Chien, E. K., Casey, B. M., Gibbs, R. S., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network 2020

  Abstract

  BACKGROUND: Although induction of labor (IOL) of low-risk nulliparous women at 39 weeks reduces the risk of cesarean delivery compared with expectant management, concern regarding more frequent use of labor induction remains given that this intervention historically has been thought to incur greater resource utilization.OBJECTIVE: To determine whether planned elective labor induction at 39 weeks among low-risk nulliparous women, compared with expectant management, was associated with differences in health care resource utilization from the time of randomization through 8 weeks postpartum.STUDY DESIGN: This is a planned secondary analysis of a multi-center randomized trial in which low-risk nulliparous women were assigned to IOL at 39 weeks or expectant management. We assessed resource utilization post-randomization in three time periods: antepartum (AP), delivery admission, and discharge through 8 weeks postpartum (PP).RESULTS: Of 6096 women with data available, those in the IOL group (n = 3059) were significantly less likely in the AP period after randomization to have at least one ambulatory visit for routine prenatal care (32.4% vs. 68.4%), unanticipated care (0.5% vs. 2.6%), or urgent care (16.2% vs. 44.3%), or at least one antepartum hospitalization (0.8% vs. 2.2%, p<0.001 for all). They also had fewer tests (e.g., sonograms, blood tests) and treatments (e.g., antibiotics, intravenous hydration) prior to delivery. During the delivery admission, women in the IOL group spent a longer time in labor and delivery (median: 0.83 vs. 0.57 days), but both women (p=0.002) and their neonates (p<0.001) had shorter postpartum stays. Women and neonates in both groups had similar frequencies of PP urgent care and hospital readmissions (p>0.05 for all).CONCLUSIONS: Women randomized to IOL had longer durations in labor and delivery, but significantly fewer AP visits, tests, and treatments, and shorter maternal and neonatal hospital durations post-delivery. These results demonstrate that the health outcome advantages associated with IOL are gained without incurring uniformly greater health care resource use.

  View details for DOI 10.1016/j.ajog.2020.01.002

  View details for PubMedID 31930993

• Maternal Sense of Control During Childbirth and Infant Feeding Method. Obstetrics and gynecology Dude, A. n., Fette, L. M., Reddy, U. M., Tita, A. T., Silver, R. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Thorp, J. M., Chauhan, S. P., Iams, J. D., Chien, E. K., Casey, B. M., Srinivas, S. K., Swamy, G. K., Simhan, H. N. 2020

  Abstract

  To estimate whether maternal sense of control in labor is associated with breastfeeding at 4-8 weeks postpartum.This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6-96 hours after delivery. The Labor Agentry Scale score, which is higher with more perceived control during childbirth, was analyzed both as a continuous and a categorical variable (quintiles). Self-reported breastfeeding at 4-8 weeks postpartum was categorized as exclusive breastfeeding, breastfeeding and formula feeding, or exclusive formula feeding. Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding. Multinomial logistic regression was used to adjust for confounders.Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860) were exclusively formula feeding 4-8 weeks after delivery. Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145-182). The median Labor Agentry Scale score was 169 (interquartile range 151-183) for women exclusively breastfeeding, 166 (interquartile range 142-182) for women who were breastfeeding and formula feeding, and 164 (interquartile range 142-181) for women who were only formula feeding (P<.001). In the unadjusted multinomial model, women with Labor Agentry Scale scores in the lowest two quintiles (ie, those with lower perceived control during childbirth) were less likely to be exclusively breastfeeding (as compared with those exclusively formula feeding) than women in the highest Labor Agentry Scale quintile. When controlling for confounders, however, this association was no longer significant.After adjustment for confounders, perceived control during childbirth was not associated with breastfeeding at 4-8 weeks postpartum among nulliparous women.ClinicalTrials.gov, NCT01990612.

  View details for DOI 10.1097/AOG.0000000000003697

  View details for PubMedID 32028504

• The obstetric clinical trial landscape: a characterization of clinicaltrials.gov investigations from 2007-2018 Steinberg, J. R., Weeks, B., Turner, B., Reyes, G., Conway, A. A., Zhang, W. Y., Lindsay, S., Anderson, J. N., Chan, K., Igbinosa, I., Girsen, A., El-Sayed, Y. Y., Lyell, D. J. MOSBY-ELSEVIER. 2020: S459–S460

  View details for DOI 10.1016/j.ajog.2019.11.739

  View details for Web of Science ID 000504997301052

• Early discontinuation and results reporting in obstetric clinical trials: An analysis of 3317 clinicaltrials.gov investigations Weeks, B., Steinberg, J. R., Turner, B., Reyes, G., Conway, A. A., Zhang, W. Y., Lindsay, S., Anderson, J. N., Chan, K., Igbinosa, I., Girsen, A., El-Sayed, Y. Y., Lyell, D. J. MOSBY-ELSEVIER. 2020: S55–S56

  View details for DOI 10.1016/j.ajog.2019.11.082

  View details for Web of Science ID 000504997300067

• Comparing insulin, metformin, and glyburide in treating diabetes in pregnancy and analyzing obstetric outcomes Sperling, M., Bentley, J., Girsen, A., Leonard, S. A., Sherwin, E. B., Panelli, D. M., Suharwardy, S., El Sayed, Y., Herrero, T. MOSBY-ELSEVIER. 2020: S481

  View details for DOI 10.1016/j.ajog.2019.11.773

  View details for Web of Science ID 000504997301086

• Sustaining the practice of operative vaginal delivery: Maternal and neonatal outcomes among a contemporary cohort Panelli, D. M., Leonard, S. A., Judy, A., El-Sayed, Y. Y., Gilbert, W., Lyell, D. J. MOSBY-ELSEVIER. 2020: S568

  View details for DOI 10.1016/j.ajog.2019.11.929

  View details for Web of Science ID 000504997301240

• Relationships of uterine fibroids to racial/ethnic disparities in severe maternal morbidity Igbinosa, I., Leonard, S. A., El-Sayed, Y. Y., Lyell, D. J. MOSBY-ELSEVIER. 2020: S170–S171

  View details for DOI 10.1016/j.ajog.2019.11.263

  View details for Web of Science ID 000504997300247

• Outcome of cerclage in pregnancies without a prior preterm birth Chueh, J., Ness, A., Mayo, J. A., El-Sayed, Y. Y., Shaw, G. M., Stevenson, D. K. MOSBY-ELSEVIER. 2020: S672–S673

  View details for DOI 10.1016/j.ajog.2019.11.1103

  View details for Web of Science ID 000504997301409

• Vaginal progesterone treatment is associated with intrahepatic cholestasis of pregnancy Tsur, A., Kan, P., Datoc, I., Leonard, S. A., Girsen, A., Shaw, G. M., Stevenson, D. K., El-Sayed, Y. Y., Druzin, M. L., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2020: S58–S59

  View details for DOI 10.1016/j.ajog.2019.11.084

  View details for Web of Science ID 000504997300069

• Do women who delivered at 34-36 weeks need serial transvaginal ultrasound cervical lengths? Ness, A., Chueh, J., Mayo, J. A., Shaw, G. M., El Sayed, Y., Stevenson, D. K. MOSBY-ELSEVIER. 2020: S401

  View details for DOI 10.1016/j.ajog.2019.11.644

  View details for Web of Science ID 000504997300627

• Maternal Health after Stillbirth: Postpartum Hospital Readmission in California. American journal of perinatology Wall-Wieler, E. n., Butwick, A. J., Gibbs, R. S., Lyell, D. J., Girsen, A. I., El-Sayed, Y. Y., Carmichael, S. L. 2020

  Abstract

   The aim of this study is to assess whether the risk of postpartum readmission within 6 weeks of giving birth differs for women who had stillbirths compared with live births. Using data from the Office of Statewide Health Planning and Development in California, we performed a population-based cohort study of 7,398,640 births between 1999 and 2011. We identified diagnoses and procedures associated with the first postpartum hospital readmission that occurred within 6 weeks after giving birth. We used log-binomial models to estimate relative risk (RR) of postpartum readmission for women who had stillbirth compared with live birth deliveries, adjusting for maternal demographic, prepregnancy, pregnancy, and delivery characteristics. The rate of postpartum readmission was higher among women who had stillbirths compared with women who had live births (206 and 96 per 10,000 births, respectively). After adjusting for maternal demographic and medical characteristics, the risk of postpartum readmission for women who had stillbirths was nearly 1.5 times greater (adjusted RR = 1.47, 95% confidence interval: 1.35-1.60) compared with live births. Among women with stillbirths, the most common indications at readmission were uterine infection or pelvic inflammatory disease, psychiatric conditions, hypertensive disorder, and urinary tract infection. Based on our findings, women who have stillbirths are at higher risk of postpartum readmissions within 6 weeks of giving birth than women who have live births. Women who have stillbirths may benefit from additional monitoring and counseling after hospital discharge for potential postpartum medical and psychiatric complications.· Women who have stillbirths are at nearly 1.5 times greater risk of postpartum readmission than women who have live births.. · Uterine infections and pelvic inflammatory disease, and psychiatric conditions are the most common reasons for readmission among women who had a stillbirth.. · Women who have stillbirths may benefit from additional monitoring and counseling after hospital discharge for potential postpartum medical and psychiatric complications..

  View details for DOI 10.1055/s-0040-1708803

  View details for PubMedID 32365389

• Maternal and Neonatal Outcomes Associated with Amniotomy among Nulliparous Women Undergoing Labor Induction at Term. American journal of perinatology Battarbee, A. N., Sandoval, G. n., Grobman, W. A., Reddy, U. M., Tita, A. T., Silver, R. M., El-Sayed, Y. Y., Wapner, R. J., Rouse, D. J., Saade, G. R., Chauhan, S. P., Iams, J. D., Chien, E. K., Casey, B. M., Gibbs, R. S., Srinivas, S. K., Swamy, G. K., Simhan, H. N. 2020

  Abstract

   The aim of the study is to evaluate the association between amniotomy at various time points during labor induction and maternal and neonatal outcomes among term, nulliparous women. Secondary analysis of a randomized trial of term labor induction versus expectant management in low-risk, nulliparous women (2014-2017) was conducted. Women met inclusion criteria if they underwent induction ≥38 weeks' gestation using oxytocin with documented time and type of membrane rupture. Women with antepartum stillbirth or fetal anomaly were excluded. The primary outcome was cesarean delivery. Secondary outcomes included maternal and neonatal complications. Maternal and neonatal outcomes were compared among women with amniotomy versus women with intact membranes and no amniotomy at six 2-hour time intervals: before oxytocin initiation, 0 to <2 hours after oxytocin, 2 to <4 hours after, 4 to <6 hours after, 6 to <8 hours after, and 8 to <10 hours after. Multivariable logistic regression adjusted for maternal age, body mass index, race/ethnicity, modified Bishop score on admission, treatment group, and hospital (as a random effect). Of 6,106 women in the parent trial, 2,854 (46.7%) women met inclusion criteria. Of these 2,340 (82.0%) underwent amniotomy, and majority of the women had amniotomy performed between 2 and <6 hours after oxytocin. Cesarean delivery was less frequent among women with amniotomy 6 to <8 hours after oxytocin compared with women without amniotomy (21.9 vs. 29.7%; adjusted odds ratio 0.61, 95% confidence interval 0.42-0.89). Amniotomy at time intervals ≥4 hours after oxytocin was associated with lower odds of labor duration >24 hours. Amniotomy at time intervals ≥2 hours and <8 hours after oxytocin was associated with lower odds of maternal hospitalization >3 days. Amniotomy was not associated with postpartum or neonatal complications. Among a contemporary cohort of nulliparous women undergoing term labor induction, amniotomy was associated with either lower or similar odds of cesarean delivery and other adverse outcomes, compared with no amniotomy.

  View details for DOI 10.1055/s-0040-1709464

  View details for PubMedID 32299106

• Preterm birth outcomes among Asian women by maternal place of birth. Journal of perinatology : official journal of the California Perinatal Association Girsen, A. I., Mayo, J. A., Datoc, I. A., Karakash, S. n., Gould, J. B., Stevenson, D. K., El-Sayed, Y. Y., Shaw, G. M. 2020

  Abstract

  To investigate overall, spontaneous, and medically indicated preterm birth (PTB) rates between US-born and non-US-born Asian women living in California.Nulliparous women with a singleton livebirth and Asian race in California between 2007 and 2011 were investigated. The prevalence of overall (<37 weeks), spontaneous, and medically indicated PTB was examined by self-reported race and place of birth among ten Asian subgroups.There were marked differences in PTB rates between the individual Asian subgroups. After adjustments, non-US-born Chinese, Japanese, Vietnamese, and Indian women had lower odds of overall PTB and Chinese, Vietnamese, Cambodian, and Indian women had lower odds of spontaneous PTB compared with their US-born counterparts.Further investigation of biological and social factors contributing to these lower odds of spontaneous PTB among the non-US-born Asian population could potentially offer clues for reducing the burden of PTB among the US born.

  View details for DOI 10.1038/s41372-020-0633-1

  View details for PubMedID 32094480

• Evaluation of Domains of Patient-Reported Outcome Measures for Recovery After Childbirth: A Scoping and Systematic Review. JAMA network open Sultan, P. n., Sadana, N. n., Sharawi, N. n., Blake, L. n., El-Boghdadly, K. n., Falvo, A. n., Ciechanowicz, S. n., Athar, W. n., Shah, R. n., Guo, N. n., Jensen, S. n., El-Sayed, Y. n., Cella, D. n., Carvalho, B. n. 2020; 3 (5): e205540

  Abstract

  Despite the global delivery rate being approximately 259 deliveries per minute in 2018, postpartum recovery remains poorly defined.To identify validated patient-reported outcome measures (PROMs) used to assess outpatient and inpatient postpartum recovery, evaluate frequency of PROM use, report the proportion of identified PROMs used within each recovery domain, report the number of published studies within each recovery domain, summarize descriptive data (country of origin, year of study, and journal specialty) for published studies using PROMs to evaluate postpartum recovery, and report PROMs used to evaluate global postpartum recovery.This study followed PRISMA-ScR guidelines. A literature search of 4 databases (MEDLINE through PubMed, Embase, Web of Science, and CINAHL) was performed on July 1, 2019, to identify PROMs used to evaluate 12 author-defined domains of postpartum recovery. All psychometrically evaluated PROMs used to evaluate inpatient or outpatient postpartum recovery after all delivery modes were included.From 8008 screened titles and abstracts, 573 studies (515 outpatient and 58 inpatient) were identified in this review. A total of 201 PROMs were used to assess recovery for outpatient studies and 73 PROMs were used to assess recovery for inpatient studies. The top 5 domains (with highest to lowest numbers of PROMs) used to assess outpatient recovery were psychosocial distress (77 PROMs), surgical complications (26 PROMs), psychosocial support (27 PROMs), motherhood experience (16 PROMs), and sexual function (13 PROMs). Among inpatient studies, the top 5 domains were psychosocial distress (32 PROMs), motherhood experience (7 PROMs), psychosocial support (5 PROMs), fatigue (5 PROMs), and cognition (3 PROMs). The 3 most frequently used PROMs were the Edinburgh Postnatal Depression Scale (267 studies), Short-Form 36 Health Questionnaire (global recovery assessment; 40 studies), and Female Sexual Function Index (35 studies). A total of 24 global recovery PROMs were identified among all included studies. Most studies were undertaken in the United States within the last decade and were published in psychiatry and obstetrics and gynecology journals.Most PROMs identified in this review evaluated a single domain of recovery. Future research should focus on determining the psychometric properties of individual and global recovery PROMs identified in this review to provide recommendations regarding optimum measures of postpartum recovery.

  View details for DOI 10.1001/jamanetworkopen.2020.5540

  View details for PubMedID 32442292

• Pregnancy outcomes of american indian and alaskan native women residing in rural versus urban areas Estes, J., Girsen, A., Sie, L., Leonard, S. A., Carmichael, S. L., El-Sayed, Y. Y. MOSBY-ELSEVIER. 2020: S97

  View details for DOI 10.1016/j.ajog.2019.11.143

  View details for Web of Science ID 000504997300127

• Operative vaginal delivery in the modern obstetric era: How does it compare to the alternative? Panelli, D. M., Leonard, S. A., Judy, A., El-Sayed, Y. Y., Gilbert, W., Lyell, D. J. MOSBY-ELSEVIER. 2020: S327–S328

  View details for DOI 10.1016/j.ajog.2019.11.519

  View details for Web of Science ID 000504997300502

• The obstetric research landscape: a cross-sectional analysis of clinical trials from 2007-2020. American journal of obstetrics & gynecology MFM Steinberg, J. R., Weeks, B. T., Reyes, G. A., Conway Fitzgerald, A. n., Zhang, W. Y., Lindsay, S. E., Anderson, J. N., Chan, K. n., Richardson, M. T., Magnani, C. J., Igbinosa, I. n., Girsen, A. n., El-Sayed, Y. Y., Turner, B. E., Lyell, D. J. 2020: 100253

  Abstract

  Obstetric complications impact over a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetric clinical trial landscape, how it compares to other fields, or factors associated with the successful completion of obstetric trials.To characterize obstetric clinical trials registered on ClinicalTrials.gov with the primary objective of identifying features associated with early discontinuation and results reporting.This is a cross-sectional study with descriptive, logistic regression and cox regression analyses of clinical trials registered on ClinicalTrials.gov. Our primary exposure variables were trial focus (obstetric or non-obstetric) and trial funding (industry, United States government or academic). We conducted additional exploratory analyses of other trial features including design, enrollment, and therapeutic focus. We examined the associations of exposure variables and other trial features with two primary outcomes: early discontinuation and results reporting.We downloaded data for all studies (n=332,417) registered on ClinicalTrials.gov from October 1, 2007 to March 9, 2020 from the Aggregate Analysis of the ClinicalTrials.gov database. We excluded studies with a non-interventional design (n=63,697) and those registered before October 1, 2007 (n=45,209). 4,276 (1.9%) obstetric trials (i.e. interventional studies), and 219,235 (98.1%) non-obstetric trials were compared. Among all trials, 2.8% of academic-funded trials, 1.9% of United States government-funded trials, and 0.4% of industry-funded trials focused on obstetrics. The quantity of obstetric trials increased over time (10.8% annual growth rate). Compared to non-obstetric trials, obstetric trials had a greater risk of early discontinuation (adjusted hazard ratio 1.40, 95% confidence interval: 1.21 to 1.62, p<0.0001) and similar odds of results reporting (adjusted odds ratio 0.89, 95% confidence interval: 0.72 to 1.10, p=0.19). Among obstetric trials funders after controlling for confounding variables, United States government-funded trials were at lowest risk of early discontinuation (US government adjusted hazard ratio 0.23, 95% confidence interval 0.07 to 0.69, p=0.009, industry reference; academic adjusted hazard ratio 1.04, 95% confidence interval 0.62 to 1.74, p=0.88). Academic-funded trials had the lowest odds of results reporting after controlling for confounding variables (academic institutions adjusted odds ratio 0.39, 95% confidence interval 0.22 to 0.68, p=0.0009; industry reference; US government adjusted odds ratio 1.06 95% confidence interval 0.53 to 2.09, p=0.87).Obstetric trials represent only 1.9% of all clinical trials in ClinicalTrials.gov and have comparatively poor completion. All stakeholders should commit to increasing the number of obstetric trials and improving their completion and dissemination to ensure clinical research reflects the obstetric burden of disease and advances maternal health.

  View details for DOI 10.1016/j.ajogmf.2020.100253

  View details for PubMedID 33043288

  View details for PubMedCentralID PMC7537600

• Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. American journal of obstetrics & gynecology MFM Sultan, P. n., Kamath, N. n., Carvalho, B. n., Bansal, P. n., Elkhateb, R. n., Dougan, S. n., Whittington, J. n., Guo, N. n., El-Sayed, Y. n., Mhyre, J. n., Sharawi, N. n. 2020; 2 (4): 100202

  Abstract

  Few adequately validated patient-reported outcome measures are available, which can assess recovery profiles following childbirth.We aimed to determine whether quantitative recovery (using the Obstetric Quality of Recovery-10 patient-reported outcome measure) was superior following vaginal delivery compared with cesarean delivery and evaluate validity, reliability, and responsiveness of this patient-reported outcome measure in the obstetrical setting in the United States.Women recruited into this single-center observational cohort study completed the Obstetric Quality of Recovery-10 and EuroQol 5-dimension 3L patient-reported outcome measures within 72 hours of childbirth. We assessed the validity with hypothesis testing and structural validity. In hypothesis testing, the primary outcome was Obstetric Quality of Recovery-10 scores after vaginal vs cesarean delivery. Secondary outcomes were differences in Obstetric Quality of Recovery-10 scores for vaginal delivery following induction of labor vs spontaneous labor and scheduled vs unplanned cesarean delivery, correlation with clinical parameters (American Society of Anesthesiologists classification grade, body mass index, length of hospital stay, estimated blood loss, transfusion requirement, antiemetic use, and neonatal intensive care unit admission), and qualitative ranking of Obstetric Quality of Recovery-10 items for each delivery mode. Structural validity was assessed by determining the correlation of the Obstetric Quality of Recovery-10 scores with the EuroQol 5-dimension 3L and global health visual analog scale scores. Reliability was assessed using Cronbach alpha and inter-item correlation of Obstetric Quality of Recovery-10 items. Responsiveness was assessed by evaluating the change in Obstetric Quality of Recovery-10 scores over the 72-hour postpartum period.Data from 215 women were analyzed. In hypothesis testing, the median (interquartile range) Obstetric Quality of Recovery-10 scores were higher following vaginal delivery than cesarean delivery (86 [77-94] vs 77 [64-86], respectively; P<.001). Multivariate model demonstrated that Obstetric Quality of Recovery-10 scores were significantly lower after cesarean delivery when adjusting for American Society of Anesthesiologists classification grade, age, body mass index, and ethnicity (R=-8.97; P<.001). Obstetric Quality of Recovery-10 scores were similar between induction of labor and spontaneous labor, and scheduled cesarean delivery and unplanned cesarean delivery. Obstetric Quality of Recovery-10 was correlated with length of hospital stay (R=-0.248; P<.001), estimated blood loss (R=-0.3429; P<.001), transfusion requirement (R=-0.140; P=.041), and antiemetic use (R=-0.280; P<.001). The highest ranked Obstetric Quality of Recovery-10 items were ability to hold baby, feeling in control, and ability to look after personal hygiene. The lowest ranked items were pain and shivering. In structural validity, correlation of Obstetric Quality of Recovery-10 score was moderate with the global health visual analog scale (r=0.511) and EuroQol 5-dimension 3L scores (r=-0.509). In reliability, Cronbach alpha was 0.72 and more than 80% of individual items correlated. In responsiveness, Obstetric Quality of Recovery-10 scores did not change significantly over the study period.Quantitative inpatient recovery following vaginal delivery is superior to cesarean delivery. The Obstetric Quality of Recovery-10 appears to be a valid and reliable patient-reported outcome measure following these delivery modes. Further studies are needed to determine how to improve recovery domains identified in this study, to evaluate Obstetric Quality of Recovery-10 in different languages and determine whether these domains impact outcomes beyond hospitalization.

  View details for DOI 10.1016/j.ajogmf.2020.100202

  View details for PubMedID 33345919

• A Genome-Wide Analysis of Clinical Chorioamnionitis among Preterm Infants AMERICAN JOURNAL OF PERINATOLOGY Spiegel, A. M., Li, J., Oehlert, J. W., Mayo, J. A., Quaintance, C. C., Girsen, A. I., Druzin, M. L., El-Sayed, Y. Y., Shaw, G. M., Stevenson, D. K., Gibbs, R. S. 2019; 36 (14): 1453–58

  View details for DOI 10.1055/s-0038-1677503

  View details for Web of Science ID 000499481500005

• Single Cell Transcriptomes Derived from Human Cervical and Uterine Tissue during Pregnancy ADVANCED BIOSYSTEMS Koh, W., Wu, A., Penland, L., Treutlein, B., Neff, N. F., Mantalas, G. L., Blumenfeld, Y. J., El-Sayed, Y. Y., Stevenson, D. K., Shaw, G. M., Quake, S. R. 2019; 3 (11)

  View details for DOI 10.1002/adbi.201800336

  View details for Web of Science ID 000498192300005

• Single Cell Transcriptomes Derived from Human Cervical and Uterine Tissue during Pregnancy. Advanced biosystems Koh, W., Wu, A., Penland, L., Treutlein, B., Neff, N. F., Mantalas, G. L., Blumenfeld, Y. J., El-Sayed, Y. Y., Stevenson, D. K., Shaw, G. M., Quake, S. R. 2019; 3 (11): e1800336

  Abstract

  This work presents the workflow for generating single cell transcriptomes derived from primary human uterine and cervical tissue obtained during planned cesarean hysterectomies. In total, a catalogue of 310 single cell transcriptomes are obtained, cell types present in these biopsies are inferred, and specific genes defining each of the cellular types present in the tissue are identified. Further validation of the inferred cell identity is also demonstrated via meta-analysis of independent repositories in literature generated by bulk sequenced data of fluorescence-activated cell sorting sorted cells.

  View details for DOI 10.1002/adbi.201800336

  View details for PubMedID 32648692

• Severe Maternal Morbidity Among Stillbirth and Live Birth Deliveries in California. Obstetrics and gynecology Wall-Wieler, E., Carmichael, S. L., Gibbs, R. S., Lyell, D. J., Girsen, A. I., El-Sayed, Y. Y., Butwick, A. J. 2019

  Abstract

  OBJECTIVE: To assess the prevalence and risk of severe maternal morbidity among delivery hospitalization for stillbirth compared with live birth deliveries.METHODS: Using data from the Office of Statewide Health Planning and Development in California, we performed a population-based cross-sectional study of 6,459,842 deliveries between 1999 and 2011. We identified severe maternal morbidity using an algorithm comprising diagnoses and procedures developed by the Centers for Disease Control and Prevention and used log-binomial regression models to examine the relative risk (RR) of severe maternal morbidity for stillbirth compared with live birth deliveries, adjusting for maternal demographic, medical, and obstetric characteristics. We also examined severe maternal morbidity prevalence by cause of fetal death among stillbirth deliveries.RESULTS: The prevalence of severe maternal morbidity for stillbirth and live birth was 578 and 99 cases per 10,000 deliveries, respectively. After adjusting for maternal demographic, medical, and obstetric characteristics, the risk of severe maternal morbidity among stillbirth deliveries was more than fourfold higher (adjusted RR 4.77; 95% CI 4.53-5.02) compared with live birth deliveries. The severe maternal morbidity prevalence was highest among stillbirths caused by hypertensive disorders and placental conditions (24 and 19 cases/100 deliveries, respectively), and lowest among stillbirths caused by fetal malformations or genetic abnormalities (1 case per 100 deliveries).CONCLUSION: Women who have stillbirths are at substantially higher risk for severe maternal morbidity than women who have live births, regardless of cause of fetal death. The prevalence of severe maternal morbidity varies by cause of fetal death.

  View details for DOI 10.1097/AOG.0000000000003370

  View details for PubMedID 31306335

• Data-Driven Queries between Medications and Spontaneous Preterm Birth among 2.5 Million Pregnancies: Association with Genital Herpes and Antiviral Drugs. Maric, I., Borisenko, E., Winn, V. D., Weber, K. A., Wong, R. J., Aziz, N., Blumenfeld, Y. J., El-Sayed, Y. Y., Stevenson, D. K., Shaw, G. M. SAGE PUBLICATIONS INC. 2019: 389A

  View details for Web of Science ID 000459610400965

• A Multidisciplinary Approach to Care of Pregnant Patients with History of Open Heart Surgery. Do, S. C., Lee, C. J., Sie, L., Tolani, A. T., Sherwin, E., Girsen, A. I., El-Sayed, Y. Y., Khandelwal, A., Bianco, K., Blumenfeld, Y. J. SAGE PUBLICATIONS INC. 2019: 323A–324A

  View details for Web of Science ID 000459610400772

• Maternal Outcomes in Planned and Unplanned Pregnancies in Women with Cardiac Disease. Do, S. C., Tolani, A. T., Sie, L., Girsen, A. I., Lee, C. J., Sherwin, E., Panelli, D. M., El-Sayed, Y. Y., Khandelwal, A., Blumenfeld, Y. J., Bianco, K. SAGE PUBLICATIONS INC. 2019: 323A

  View details for Web of Science ID 000459610400771

• Vasa previa and extreme prematurity: a population-based study. Journal of perinatology : official journal of the California Perinatal Association Yeaton-Massey, A., Girsen, A. I., Mayo, J. A., Blumenfeld, Y. J., El-Sayed, Y. Y., Stevenson, D. K., Shaw, G. M. 2019

  Abstract

  OBJECTIVE: To determine population-based risks of preterm birth associated with vasa previa.STUDY DESIGN: Included were 945,950 singleton, live birth cesarean deliveries with and without vasa previa (gestational ages 24-41 weeks) in California between 2007 and 2012. Odds ratios (ORs) of preterm birth were estimated using logistic regression.RESULTS: In total, 586 were complicated by vasa previa (0.06%). In total, 369 (63%) of those with vasa previa were delivered <37 weeks, compared with 91,662 (10%) of those without. Odds of extreme and very preterm birth were substantially higher for pregnancies with vasa previaeven after controlling for comorbidities known to contribute to prematurity, with ORs of 4.6 (95% confidence interval, CI: 1.7-12.5) and 16.0 (95% CI: 10.3-24.8), respectively.CONCLUSION: Based on these population-based data, most patients with vasa previa are delivered between 32 and 36 weeks gestation; however, a clinically significant portion occur before 32 weeks. These data are helpful in counseling patients with vasa previa regarding prematurity risk.

  View details for PubMedID 30692614

• A Genome-Wide Analysis of Clinical Chorioamnionitis among Preterm Infants. American journal of perinatology Spiegel, A. M., Li, J., Oehlert, J. W., Mayo, J. A., Quaintance, C. C., Girsen, A. I., Druzin, M. L., El-Sayed, Y. Y., Shaw, G. M., Stevenson, D. K., Gibbs, R. S. 2019

  Abstract

  OBJECTIVE: To identify single nucleotide polymorphisms (SNPs) associated with clinical chorioamnionitis among preterm infants.STUDY DESIGN: We reanalyzed a genome-wide association study (GWAS) from preterm newborns at less than 30 weeks' gestation. Cases and control definitions were determined using administrative records. There were 213 clinical chorioamnionitis cases and 707 clinically uninfected controls. We compared demographic and clinical outcomes of cases and controls. We performed a GWAS and compared the distribution of SNPs from the background genes and from the immunome genes. We used a Wilcoxon's rank-sum test to compare the SNPs normalized odds ratio and used odds ratios and p-values to determine candidate genes.RESULTS: Infants affected by clinical chorioamnionitis were more likely to have periventricular leukomalacia, high-grade retinopathy, and high-grade intraventricular hemorrhage (IVH). Although a GWAS did not identify SNPs associated with clinical chorioamnionitis at the genome-wide significance level, a direct test on the exonic variants in the human immunome revealed their significant increase of risk in clinical chorioamnionitis.CONCLUSION: Among very preterm infants, clinical chorioamnionitis was associated with periventricular leukomalacia, high-grade retinopathy, and IVH. Our analysis of variants in the human immunome indicates an association with clinical chorioamnionitis in very preterm pregnancies.

  View details for PubMedID 30674050

• Care of the pregnant cardiac patient e the importance of a multidisciplinary approach Tolani, A. T., Do, S. C., Blumenfeld, Y. J., Sie, L., Girsen, A. I., Lee, C. J., Sherwin, E. B., Tsur, A., El-Sayed, Y. Y., Khandelwal, A., Bianco, K. MOSBY-ELSEVIER. 2019: S536

  View details for DOI 10.1016/j.ajog.2018.11.842

  View details for Web of Science ID 000454249402297

• Data-driven queries between medications and spontaneous preterm birth among 2.5 million pregnancies. Birth defects research Marić, I. n., Winn, V. D., Borisenko, E. n., Weber, K. A., Wong, R. J., Aziz, N. n., Blumenfeld, Y. J., El-Sayed, Y. Y., Stevenson, D. K., Shaw, G. M. 2019

  Abstract

  Our goal was to develop an approach that can systematically identify potential associations between medication prescribed in pregnancy and spontaneous preterm birth (sPTB) by mining large administrative "claims" databases containing hundreds of medications. One such association that we illustrate emerged with antiviral medications used for herpes treatment.IBM MarketScan® databases (2007-2016) were used. A pregnancy cohort was established using International Classification of Diseases (ICD-9/10) codes. Multiple hypothesis testing and the Benjamini-Hochberg procedure that limited false discovery rate at 5% revealed, among 863 medications, five that showed odds ratios (ORs) <1. The statistically strongest was an association between antivirals and sPTB that we illustrate as a real example of our approach, specifically for treatment of genital herpes (GH). Three groups of women were identified based on diagnosis of GH and treatment during the first 36 weeks of pregnancy: (a) GH without treatment; (b) GH treated with antivirals; (c) no GH or treatment.We identified 2,538,255 deliveries. 0.98% women had a diagnosis of GH. Among them, 60.0% received antiviral treatment. Women with treated GH had OR < 1, (OR [95% CI] = 0.91 [0.85, 0.98]). In contrast, women with untreated GH had a small increased risk of sPTB (OR [95% CI] =1.22 [1.14, 1.32]).Data-driven approaches can effectively generate new hypotheses on associations between medications and sPTB. This analysis led us to examine the association with GH treatment. While unknown confounders may impact these findings, our results indicate that women with untreated GH have a modest increased risk of sPTB.

  View details for DOI 10.1002/bdr2.1580

  View details for PubMedID 31433567

• Pregnancy after direct cerebral bypass for moyamoya disease. Journal of neurosurgery Church, E. W., Qaiser, R. n., Bell-Stephens, T. E., Bigder, M. G., Chow, E. K., Han, S. S., El-Sayed, Y. Y., Steinberg, G. K. 2019: 1–7

  Abstract

  Moyamoya disease (MMD) disproportionately affects young to middle-aged women. The main treatment for this challenging disease is cerebral bypass surgery. Vascular neurosurgeons often need to counsel women regarding pregnancy following bypass for MMD, but there is a paucity of data. The authors set out to examine neurological and obstetric outcomes in an extensive cohort of MMD patients who had pregnancies following cerebral revascularization at the Stanford Medical Center.The authors identified all patients at their institution who underwent cerebral bypass for MMD from 1990 through 2018 and who later became pregnant. Some of these patients also had pregnancies prior to undergoing bypass surgery, and the authors examined these pregnancies as well. They performed a chart review and brief telephone survey to identify obstetric complications, transient ischemic attacks (TIAs), and strokes. Neurological and obstetric outcomes were compared to published rates. They also compared pre- and post-bypass pregnancy complication rates using logistic regression techniques.There were 71 pregnancies among 56 women whose mean age was 30.5 years. Among 59 post-bypass pregnancies, there were 5 (8%) perinatal TIAs. There were no MRI-confirmed strokes or strokes with residual deficits. Among 12 pre-bypass pregnancies, there were 3 (25%) TIAs and 2 (17%) MRI-confirmed strokes. There were no hemorrhagic complications in either group. In the generalized estimating equations analysis, performing cerebral revascularization prior to pregnancy versus after pregnancy was associated with lower odds of perinatal stroke or TIA (OR 0.15, p = 0.0061). Nine pregnancies (13%) were complicated by preeclampsia, and there was one (1%) instance of eclampsia. The overall rate of cesarean delivery was 39%. There were 2 miscarriages, both occurring in the first trimester. There were no maternal deaths.The authors present neurological and obstetric outcomes data in a large cohort of MMD patients. These data indicate that post-bypass pregnancy is accompanied by low complication rates. There were no ischemic or hemorrhagic strokes among post-bypass pregnant MMD patients. The rate of obstetric complications was low overall. The authors recommend close collaboration between the vascular neurosurgeon and the obstetrician regarding medical management, including blood pressure goals and continuation of low-dose aspirin.

  View details for DOI 10.3171/2019.8.JNS191372

  View details for PubMedID 31731267

• Obstetric and neonatal outcomes in pregnancies complicated by fetal lung masses: does final histology matter? The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians Anderson, J. N., Girsen, A. I., Hintz, S. R., El-Sayed, Y. Y., Davis, A. S., Barth, R. A., Halabi, S. n., Hazard, F. K., Sylvester, K. G., Bruzoni, M. n., Blumenfeld, Y. J. 2019: 1–7

  Abstract

  Purpose: Fetal lung masses complicate approximately 1 in 2000 live births. Our aim was to determine whether obstetric and neonatal outcomes differ by final fetal lung mass histology.Materials and methods: A review of all pregnancies complicated by a prenatally diagnosed fetal lung mass between 2009 and 2017 at a single academic center was conducted. All cases included in the final analysis underwent surgical resection and histology diagnosis was determined by a trained pathologist. Clinical data were obtained from review of stored electronic medical records which contained linked maternal and neonatal records. Imaging records included both prenatal ultrasound and magnetic resonance imaging. Fisher's exact test was used for categorical variables and the Kruskal-Wallis test was used for continuous variables. The level of significance was p<.05.Results: Of 61 pregnancies complicated by fetal lung mass during the study period, 45 cases underwent both prenatal care and postnatal resection. Final histology revealed 10 cases of congenital pulmonary airway malformation (CPAM) type 1, nine cases of CPAM type 2, and 16 cases of bronchopulmonary sequestration. There was no difference in initial, maximal, or final CPAM volume ratio between groups, with median final CPAM volume ratio of 0.6 for CPAM type 1, 0.7 for CPAM type 2, and 0.3 for bronchopulmonary sequestration (p = .12). There were no differences in any of the maternal or obstetric outcomes including gestational age at delivery and mode of delivery between the groups. The primary outcome of neonatal respiratory distress was not statistically different between groups (p = .66). Median neonatal length of stay following delivery ranged from 3 to 4 days, and time to postnatal resection was similar as well, with a median of 126 days for CPAM type 1, 122 days for CPAM type 2, and 132 days for bronchopulmonary sequestration (p = .76).Conclusions: In our cohort, there was no significant association between histologic lung mass subtypes and any obstetric or neonatal morbidity including respiratory distress.

  View details for DOI 10.1080/14767058.2019.1689559

  View details for PubMedID 31722592

• Preterm birth occurrence among Asian women relative to their place of birth Girsen, A., Mayo, J. A., Datoc, I., Karakash, S., El-Sayed, Y. Y., Shaw, G. M. MOSBY-ELSEVIER. 2019: S352

  View details for DOI 10.1016/j.ajog.2018.11.546

  View details for Web of Science ID 000454249402006

• Outcomes of women with primary and secondary pulmonary hypertension during pregnancy Blumenfeld, Y. J., Girsen, A. I., Druzin, M. L., Lyell, D. J., Bianco, K. Y., Herrero, T., Bentley, J., Seckel, E., Zamanian, R. T., El-Sayed, Y. Y. MOSBY-ELSEVIER. 2019: S405

  View details for DOI 10.1016/j.ajog.2018.11.633

  View details for Web of Science ID 000454249402093

• Readmission following discharge on labetalol or nifedipine for management of hypertensive disorders of pregnancy Do, S. C., Panelli, D. M., Girsen, A. I., Suharwardy, S., Estes, J., Gibbs, R. S., El-Sayed, Y., Lyell, D. J., Druzin, M. L., Bentley, J. MOSBY-ELSEVIER. 2019: S341

  View details for DOI 10.1016/j.ajog.2018.11.530

  View details for Web of Science ID 000454249401294

• Obstetric outcomes for women receiving newer generation antiepileptic drugs: retrospective cohort study using claims database Herrero, T., Bentley, J. P., Girsen, A. I., Do, S., Suharwardy, S., Panelli, D. M., Lyell, D. J., El-Sayed, Y., Druzin, M. L. MOSBY-ELSEVIER. 2019: S344–S345

  View details for Web of Science ID 000454249401299

• Obstetric and neonatal outcomes in pregnancies complicated by fetal lung masses: does final histology matter? Anderson, J. N., Girsen, A. I., Hintz, S. R., El-Sayed, Y. Y., Davis, A. S., Barth, R. A., Halabi, S., Sylvester, K. G., Bruzoni, M., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2019: S151

  View details for DOI 10.1016/j.ajog.2018.11.230

  View details for Web of Science ID 000454249400210

• Individualized Growth Assessment in pregnancies complicated by fetal gastroschisis Sherwin, E. B., Deter, R. L., Lee, W., El-Sayed, Y. Y., Girsen, A. I., Datoc, I. A., Hintz, S. R., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2019: S140–S141

  View details for DOI 10.1016/j.ajog.2018.11.214

  View details for Web of Science ID 000454249400194

• Congenital diaphragmatic hernia-associated neonatal morbidity and mortality based on TOTAL trial severity designation Boissiere, J. C., Anderson, J. N., Girsen, A. I., Hintz, S. R., El-Sayed, Y. Y., Van Meurs, K. P., Sylvester, K. G., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2019: S667–S668

  View details for DOI 10.1016/j.ajog.2018.11.1064

  View details for Web of Science ID 000454249403200

• Prepregnancy maternal body mass index and venous thromboembolism: A population based cohort study. BJOG : an international journal of obstetrics and gynaecology Butwick, A. J., Bentley, J., Leonard, S. A., Carmichael, S. L., El-Sayed, Y. Y., Stephansson, O., Guo, N. 2018

  Abstract

  OBJECTIVE: To assess the relationship between maternal body mass index (BMI) and pregnancy-related venous thromboembolism (VTE).DESIGN: Cross-sectional study.SETTING & POPULATION: 2,449,133 women with singleton pregnancies who underwent delivery hospitalization in California between 2008 and 2012.METHODS: Association of prepregnancy BMI and the risk of an antepartum and postpartum VTE was examined using logistic regression, with normal BMI as reference.MAIN OUTCOME MEASURES: Antepartum and postpartum VTE related hospitalization.RESULTS: The prevalences of antepartum and postpartum VTE increased with increasing BMI (antepartum: 2.3, 3.0, 3.8, 4.2, 4.7, and 10.6 per 10 000 women for underweight, normal BMI, overweight, obesity class I, II, and III, P<0.001. postpartum: 2.0, 3.1, 3.9, 5.6, 9.0, and 13.2 per 10 000 women, P<0.01). The adjusted odds of antepartum and postpartum VTE increased progressively with increasing BMI, and obese class III women being at highest risk of pregnancy-related VTE compared with normal BMI women: adjusted odds ratio (OR) for antepartum VTE: 2.9; 95% CI 2.2-3.8 and adjusted OR for postpartum VTE: 3.6; 95% CI 2.9-4.6.CONCLUSIONS: Our findings clearly demonstrate an increasing risk of pregnancy-related VTE with increasing BMI. This article is protected by copyright. All rights reserved.

  View details for PubMedID 30500109

• Intrapartum Fetal Heart Rate Tracing Among Small-for-Gestational Age Compared With Appropriate-for-Gestational-Age Neonates. Obstetrics and gynecology Chauhan, S. P., Weiner, S. J., Saade, G. R., Belfort, M. A., Reddy, U. M., Thorp, J. M., Tita, A. T., Miller, R. S., Dinsmoor, M. J., McKenna, D. S., Stetzer, B., Rouse, D. J., Gibbs, R. S., El-Sayed, Y. Y., Sorokin, Y., Caritis, S. N., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network 2018

  Abstract

  OBJECTIVE: To compare fetal heart rate (FHR) patterns during the last hour of labor between small-for-gestational-age (SGA; birth weight less than the 10th percentile for gestational age) and appropriate-for-gestational-age (AGA; birth weight at the 10-90th percentile) neonates at 36 weeks of gestation or greater. We also compared the rate of cesarean delivery and composite neonatal morbidity among SGA and AGA newborns.METHODS: This is a secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis. We excluded women with chorioamnionitis, insufficient duration of FHR tracing in the hour before delivery, and anomalous newborns. Fetal heart rate patterns were categorized by computerized pattern recognition software (PeriCALM Patterns). Composite neonatal morbidity was defined as any of the following: intrapartum fetal death, Apgar score 3 or less at 5 minutes, cord artery pH 7.05 or less, base deficit 12 mmol/L or greater, neonatal seizure, intubation at delivery, neonatal encephalopathy, and neonatal death. Logistic regression was used to evaluate the association between FHR patterns and SGA adjusted for magnesium sulfate exposure and stage of labor.RESULTS: Of the 11,108 women randomized, 85% (n=9,402) met inclusion criteria, of whom 9% were SGA. In the last hour, the likelihood of accelerations was significantly lower among SGA than AGA neonates (72.4% vs 66.8%; P=.001). Variable decelerations lasting greater than 60 seconds, with depth greater than 60 beats per minute (bpm) or nadir less than 60 bpm, were significantly more common with SGA than AGA (all P<.001). The rate of late decelerations, prolonged decelerations, or bradycardia were similar between SGA and AGA (all P>.05). Cesarean delivery for fetal indications was significantly more common with SGA (7.0%) than AGA (4.0%; P<.001). The composite neonatal morbidity was 1.4% among SGA and 1.0% among AGA (odds ratio 1.40, 95% CI 0.74-2.64).CONCLUSION: Although the FHR patterns in the last hour of labor differ among SGA and AGA neonates, as does the rate of cesarean delivery, the composite neonatal morbidity was similar.

  View details for PubMedID 30204687

• Erratum to: A Double-Blind, Randomized, Placebo-Controlled Trial of 17 Alpha-hydroxyprogesterone Caproate in the Management of Preterm Premature Rupture of Membranes. American journal of perinatology Langen, E. S., Sit, A., Sherwin, K., Lyell, D. J., Blumenfeld, Y. J., El-Sayed, Y. Y. 2018

  View details for PubMedID 29925090

• Neonatal Outcomes of Pregnancies Complicated by Maternal Homelessness in California. Spiegel, A. M., Sie, L., Sherwin, K. B., St Martin, B. S., Girsen, A. I., Shaw, G. M., Lee, H. C., El-Sayed, Y. Y. SAGE PUBLICATIONS INC. 2018: 135A

  View details for Web of Science ID 000429928200237

• Demographic Characteristics and Outcomes of Pregnancies among Homeless Women in California. Spiegel, A. M., Sie, L., Sherwin, K. B., St Martin, B. S., Girsen, A. I., Shaw, G. M., Lee, H. C., El-Sayed, Y. Y. SAGE PUBLICATIONS INC. 2018: 87A

  View details for Web of Science ID 000429928200091

• Noninvasive Prenatal Diagnosis of Single-Gene Disorders by Use of Droplet Digital PCR CLINICAL CHEMISTRY Camunas-Soler, J., Lee, H., Hudgins, L., Hintz, S. R., Blumenfeld, Y. J., El-Sayed, Y. Y., Quake, S. R. 2018; 64 (2): 336–45

  View details for DOI 10.1373/clinchem.2017.278101

  View details for Web of Science ID 000424396200017

• Noninvasive Prenatal Diagnosis of Single-Gene Disorders by Use of Droplet Digital PCR. Clinical chemistry Camunas-Soler, J., Lee, H., Hudgins, L., Hintz, S. R., Blumenfeld, Y. J., El-Sayed, Y. Y., Quake, S. R. 2018; 64 (2): 336-345

  Abstract

  Prenatal diagnosis in pregnancies at risk of single-gene disorders is currently performed using invasive methods such as chorionic villus sampling and amniocentesis. This is in contrast with screening for common aneuploidies, for which noninvasive methods with a single maternal blood sample have become standard clinical practice.We developed a protocol for noninvasive prenatal diagnosis of inherited single-gene disorders using droplet digital PCR from circulating cell-free DNA (cfDNA) in maternal plasma. First, the amount of cfDNA and fetal fraction is determined using a panel of TaqMan assays targeting high-variability single-nucleotide polymorphisms. Second, the ratio of healthy and diseased alleles in maternal plasma is quantified using TaqMan assays targeting the mutations carried by the parents. Two validation approaches of the mutation assay are presented.We collected blood samples from 9 pregnancies at risk for different single-gene disorders, including common conditions and rare metabolic disorders. We measured cases at risk of hemophilia, ornithine transcarbamylase deficiency, cystic fibrosis, β-thalassemia, mevalonate kinase deficiency, acetylcholine receptor deficiency, and DFNB1 nonsyndromic hearing loss. We correctly differentiated affected and unaffected pregnancies (2 affected, 7 unaffected), confirmed by neonatal testing. We successfully measured an affected pregnancy as early as week 11 and with a fetal fraction as low as 3.7% (0.3).Our method detects single-nucleotide mutations of autosomal recessive diseases as early as the first trimester of pregnancy. This is of importance for metabolic disorders in which early diagnosis can affect management of the disease and reduce complications and anxiety related to invasive testing.

  View details for DOI 10.1373/clinchem.2017.278101

  View details for PubMedID 29097507

• A Double-Blind, Randomized, Placebo-Controlled Trial of 17 Alpha-hydroxyprogesterone Caproate in the Management of Preterm Premature Rupture of Membranes. American journal of perinatology Langen, E. S., Sit, A., Sherwin, K., Lyell, D. J., Blumenfeld, Y. J., El-Sayed, Y. Y. 2018

  Abstract

  OBJECTIVE: The objective of this study was to evaluate whether weekly administration of 17 alpha-hydroxyprogesterone caproate (17-OHPC) increases the number of women who achieve 34 weeks of gestation after preterm premature rupture of membranes (PPROM).STUDY DESIGN: We conducted a multicenter double-blind, randomized controlled trial of 17-OHPC versus placebo among women with PPROM. Women with singleton pregnancy, clinically confirmed PPROM, and without evidence of active infection or major fetal malformation between 240/7 and 320/7 weeks of pregnancy were offered enrollment. Women received weekly injections of 17-OHPC versus placebo until 340/7 weeks of gestation or delivery. The remainder of care was per hospital protocol. The primary outcome was achievement of 34 weeks of gestation. Secondary outcomes included length of latency and maternal and fetal outcomes.RESULTS: In this study, 21 women were enrolled. Eleven women received placebo and 10 received 17-OHPC. The study was closed prematurely secondary to poor enrollment. None of the women remained pregnant until 34 weeks of gestation. The median latency periods were 8 and 14.5 days for the placebo and 17-OHPC groups, respectively (p=0.14). There were no differences in maternal or neonatal outcomes.CONCLUSION: We did not identify any benefit from administration of 17-OHPC in pregnancies complicated by PPROM.

  View details for PubMedID 29298456

• Imaging before 24 weeks gestation can predict neonatal respiratory morbidity in pregnancies complicated by fetal lung masses Sherwin, K., Girsen, A. I., Halabi, S. S., Spiegel, A. M., Lee, C. J., Hintz, S. R., El-Sayed, Y. Y., Barth, R. A., Blumenfeld, Y. J. MOSBY-ELSEVIER. 2018: S287–S288

  View details for Web of Science ID 000422946900478

• Maternal morbidity after forceps vs vacuum assisted delivery - Outcomes from a large state-wide cohort Bentley, J., Lyell, D., El-Sayed, Y., Ness, A., Foeller, M., Bianco, K., Spiegel, A., Martin, B., Do, S., Blumenfeld, Y. MOSBY-ELSEVIER. 2018: S345

  View details for Web of Science ID 000423616600075

• Neonatal outcomes after operative vaginal delivery - are forceps or vacuum safer? Bentley, J. P., Lee, H., Lyell, D., El-Sayed, Y., Ness, A., Bianco, K., Yeaton-Massey, A., Blumenfeld, Y. MOSBY-ELSEVIER. 2018: S343–S344

  View details for Web of Science ID 000423616600073

• Patterns of maternal and neonatal morbidity in operative vaginal delivery Bentley, J., Lee, H., Lyell, D., El-Sayed, Y., Ness, A., Foeller, M., Blumenfeld, Y. MOSBY-ELSEVIER. 2018: S345–S346

  View details for Web of Science ID 000423616600076

• Hospital variations in the use of forceps assisted delivery - results from a state-wide analysis Bentley, J., Lee, H., Lyell, D., El-Sayed, Y., Ness, A., Bianco, K., Spiegel, A., Blumenfeld, Y. MOSBY-ELSEVIER. 2018: S344

  View details for Web of Science ID 000423616600074

• Effect of Maternal Body Mass Index on Postpartum Hemorrhage. Anesthesiology Butwick, A. J., Abreo, A. n., Bateman, B. T., Lee, H. C., El-Sayed, Y. Y., Stephansson, O. n., Flood, P. n. 2018

  Abstract

  It is unclear whether obesity is a risk factor for postpartum hemorrhage. The authors hypothesized that obese women are at greater risk of hemorrhage than women with a normal body mass index.The authors conducted a cohort study of women who underwent delivery hospitalization in California between 2008 and 2012. Using multilevel regression, the authors examined the relationships between body mass index with hemorrhage (primary outcome), atonic hemorrhage, and severe hemorrhage (secondary outcomes). Stratified analyses were performed according to delivery mode.The absolute event rate for hemorrhage was 60,604/2,176,673 (2.8%). In this cohort, 4% of women were underweight, 49.1% of women were normal body mass index, 25.9% of women were overweight, and 12.7%, 5.2%, and 3.1% of women were in obesity class I, II, and III, respectively. Compared to normal body mass index women, the odds of hemorrhage and atonic hemorrhage were modestly increased for overweight women (hemorrhage: adjusted odds ratio [aOR], 1.06; 99% CI, 1.04 to 1.08; atonic hemorrhage: aOR, 1.07; 99% CI, 1.05 to 1.09) and obesity class I (hemorrhage: aOR, 1.08; 99% CI, 1.05 to 1.11; atonic hemorrhage; aOR, 1.11; 99% CI, 1.08 to 1.15). After vaginal delivery, overweight and obese women had up to 19% increased odds of hemorrhage or atonic hemorrhage; whereas, after cesarean delivery, women in any obesity class had up to 14% decreased odds of severe hemorrhage.The authors' findings suggest that, at most, maternal obesity has a modest effect on hemorrhage risk. The direction of the association between hemorrhage and body mass index may differ by delivery mode.

  View details for PubMedID 29346134

• Evaluation of Probiotic Oral Supplementation Effects on Group B Streptococcus Rectovaginal Colonization in Pregnant Women: A Randomized Double-Blind Placebo-Controlled Trial Aziz, N., Spiegel, A., Bentley, J., Yoffe, P., Klikoff, A., Ehrlich, K., El-Sayed, Y., Benitz, W., Norton, M. E., Taslimi, M. M. MOSBY-ELSEVIER. 2018: S509–S510

  View details for Web of Science ID 000423616600353

• Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. The New England journal of medicine Grobman, W. A., Rice, M. M., Reddy, U. M., Tita, A. T., Silver, R. M., Mallett, G., Hill, K., Thom, E. A., El-Sayed, Y. Y., Perez-Delboy, A., Rouse, D. J., Saade, G. R., Boggess, K. A., Chauhan, S. P., Iams, J. D., Chien, E. K., Casey, B. M., Gibbs, R. S., Srinivas, S. K., Swamy, G. K., Simhan, H. N., Macones, G. A., Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network 2018; 379 (6): 513–23

  Abstract

  Background The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain. Methods In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days of gestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was cesarean delivery. Results A total of 3062 women were assigned to labor induction, and 3044 were assigned to expectant management. The primary outcome occurred in 4.3% of neonates in the induction group and in 5.4% in the expectant-management group (relative risk, 0.80; 95% confidence interval [CI], 0.64 to 1.00). The frequency of cesarean delivery was significantly lower in the induction group than in the expectant-management group (18.6% vs. 22.2%; relative risk, 0.84; 95% CI, 0.76 to 0.93). Conclusions Induction of labor at 39 weeks in low-risk nulliparous women did not result in a significantly lower frequency of a composite adverse perinatal outcome, but it did result in a significantly lower frequency of cesarean delivery. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ARRIVE ClinicalTrials.gov number, NCT01990612 .).

  View details for PubMedID 30089070

• Numerous uncharacterized and highly divergent microbes which colonize humans are revealed by circulating cell-free DNA PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA Kowarsky, M., Camunas-Soler, J., Kertesz, M., De Vlaminck, I., Koh, W., Pan, W., Martin, L., Neff, N. F., Okamoto, J., Wong, R. J., Kharbanda, S., El-Sayed, Y., Blumenfeld, Y., Stevenson, D. K., Shaw, G. M., Wolfe, N. D., Quake, S. R. 2017; 114 (36): 9623–28

  Abstract

  Blood circulates throughout the human body and contains molecules drawn from virtually every tissue, including the microbes and viruses which colonize the body. Through massive shotgun sequencing of circulating cell-free DNA from the blood, we identified hundreds of new bacteria and viruses which represent previously unidentified members of the human microbiome. Analyzing cumulative sequence data from 1,351 blood samples collected from 188 patients enabled us to assemble 7,190 contiguous regions (contigs) larger than 1 kbp, of which 3,761 are novel with little or no sequence homology in any existing databases. The vast majority of these novel contigs possess coding sequences, and we have validated their existence both by finding their presence in independent experiments and by performing direct PCR amplification. When their nearest neighbors are located in the tree of life, many of the organisms represent entirely novel taxa, showing that microbial diversity within the human body is substantially broader than previously appreciated.

  View details for PubMedID 28830999

• Association between small-for-gestational age and neurocognitive impairment at two years of corrected age among infants born at preterm gestational ages: a cohort study. Journal of perinatology Girsen, A. I., Do, S. C., El-Sayed, Y. Y., Hintz, S. R., Blumenfeld, Y. J. 2017

  Abstract

  To investigate the association between small-for-gestational age (SGA) and neurocognitive impairment at 2 years of corrected age among infants born at preterm gestational ages.A secondary analysis of a prospectively conducted NICHD/Maternal-Fetal Medicine Units BEAM trial. Non-anomalous pregnancies delivered before 37 weeks of gestation were included in the analysis. Neurocognitive outcomes at 2 years of corrected age were compared between infants who were SGA (<10% for gestational age) and those appropriately grown (AGA). The primary outcome was a severe or moderate neurocognitive impairment at 2 years of corrected age among survivors, defined as either mental (MDI) or psychomotor (PDI) developmental index score <70 for severe and <85 for moderate impairment.Of 2299 preterm neonates 67 (3%) were SGA. SGA infants were more often twin pregnancies (31% vs 17%, P=0.003) and delivered more often by cesarean section (63% vs 40%, P<0.001) at similar gestational ages (30.0±2.6 vs 29.5±2.8 weeks, P=0.11). At 2 years of corrected age, SGA and AGA survivors had similar rates of neurocognitive impairment (MDI <70: 18% vs 18%, P=1.0; MDI <85: 44% vs 46%, P=0.96; PDI <70: 20% vs 15%, P=0.51; PDI <85: 40% vs 34%, P=0.48).In this cohort, SGA at preterm gestational ages was associated with similar rates of neurocognitive impairment at two years of corrected age among surviving infants.Journal of Perinatology advance online publication, 27 April 2017; doi:10.1038/jp.2017.58.

  View details for DOI 10.1038/jp.2017.58

  View details for PubMedID 28448062

• Risk Factors for Severe Postpartum Hemorrhage After Cesarean Delivery: Case-Control Studies. Anesthesia and analgesia Butwick, A. J., Ramachandran, B., Hegde, P., Riley, E. T., El-Sayed, Y. Y., Nelson, L. M. 2017

  Abstract

  Women who undergo intrapartum caesarean delivery (CD) are at increased risk of postpartum hemorrhage (PPH) compared with those undergoing prelabor CD. To determine whether the presence and strength of the associations between individual risk factors and severe PPH vary among women undergoing prelabor CD or intrapartum CD, stratified analyses are needed according to CD subtype.To identify risk factors for severe PPH within 2 distinct CD populations, prelabor CD and intrapartum CD, we performed 2 case-control studies. Women in each study cohort delivered at a tertiary obstetric center in the United States between 2002 and 2012. For each study, cases were women who had a blood loss ≥1500 mL or who received an intraoperative or postoperative transfusion up to 48 hours after delivery. Risk factors for severe PPH among women undergoing prelabor CD or intrapartum CD were examined in separate logistic regression models.For prelabor CD, we identified 269 cases and 550 controls. Clinical factors with the highest adjusted odds for severe PPH during prelabor CD were general anesthesia (adjusted odds ratio [aOR] = 22.3; 95% confidence interval [CI] = 4.9-99.9; reference group = spinal anesthesia), multiple pregnancies (aOR = 8.0; 95% CI = 4.2-15.0; reference group = singleton pregnancy), and placenta previa (aOR = 6.3; 95% CI = 3.4-11.8). For intrapartum CD, we identified 278 cases and 572 controls. Clinical factors with the highest adjusted odds for severe PPH during intrapartum CD were general anesthesia (aOR = 5.4; 95% CI = 1.7-17.1), multiple pregnancies (aOR = 3.2; 95% CI = 1.7-6.3), and a predelivery hemoglobin ≤ 9.9 g/dL (aOR = 3.0; 95% CI = 1.3-6.9; reference group = predelivery hemoglobin ≥ 11 g/dL).Women who undergo prelabor CD and intrapartum CD have several shared risk factors for severe PPH (general anesthesia and multiple pregnancies). However, the risk factor profiles for severe PPH differed between these CD cohorts. Recognizing these differences may be important when planning resources and interventions for high-risk patients undergoing either prelabor or intrapartum CD.

  View details for DOI 10.1213/ANE.0000000000001962

  View details for PubMedID 28277324

• Effect of a High-Rate Versus a Low-Rate Oxytocin Infusion for Maintaining Uterine Contractility During Elective Cesarean Delivery: A Prospective Randomized Clinical Trial. Anesthesia and analgesia Duffield, A., McKenzie, C., Carvalho, B., Ramachandran, B., Yin, V., El-Sayed, Y. Y., Riley, E. T., Butwick, A. J. 2017; 124 (3): 857-862

  Abstract

  Oxytocin is routinely used as prophylaxis against uterine atony. During elective cesarean delivery (CD), an oxytocin bolus is used to initiate adequate uterine tone, followed by an oxytocin infusion to maintain uterine contractility. However, it is unclear whether oxytocin maintenance infusion rate influences total estimated blood loss (EBL).We performed a prospective, randomized, double-blind trial in 51 women undergoing elective CD. Women were randomly assigned to receive an oxytocin maintenance infusion of 2.5 or 15 U/h. All women received an oxytocin 1 U bolus to initiate adequate uterine tone. The primary outcome was EBL. EBL values between groups were compared using a Mann-Whitney U test; P < .05 as statistically significant. The median EBL difference with 95% confidence intervals was also calculated. Secondary outcomes included adequacy of uterine tone, use of additional uterotonics, and oxytocin-related side effects, including hypotension.Of 51 women, 24 received a low-rate infusion and 27 received a high-rate infusion. Median (interquartile range) EBL values in the low-rate and high-rate groups were 634 (340-886) mL versus 512 (405-740) mL, respectively (P = .7). The median difference in EBL between groups was 22 mL; 95% confidence interval = -158 to 236 mL. The rate of postpartum hemorrhage did not differ between groups (low-rate group: 4/24 [16.7%] versus high-rate group: 4/26 [15.4%]). There were no between-group differences over time (first 20 minutes after commencing infusion) in the incidence of adequate uterine tone (P = .72) or hypotension (P = .32).Among women undergoing elective CD receiving an oxytocin maintenance infusion, EBL and uterine tone did not differ between women receiving 2.5 U/h oxytocin and those receiving 15 U/h oxytocin. Our findings suggest that efficacy can be obtained with a low oxytocin maintenance infusion rate; however, dose-finding studies are needed to determine the infusion rate that optimizes drug efficacy while minimizing side effects.

  View details for DOI 10.1213/ANE.0000000000001658

  View details for PubMedID 28212181

  View details for PubMedCentralID PMC5319709

• Utility of third trimester sonographic measurements for predicting SGA in cases of fetal gastroschisis. Journal of perinatology Blumenfeld, Y. J., Do, S., Girsen, A. I., DAVIS, A. S., Hintz, S. R., Desai, A. K., Mansour, T., Merritt, T. A., Oshiro, B. T., El-Sayed, Y. Y., Shamshirsaz, A. A., Lee, H. C. 2017

  Abstract

  To assess the accuracy of different sonographic estimated fetal weight (EFW) cutoffs, and combinations of EFW and biometric measurements for predicting small for gestational age (SGA) in fetal gastroschisis.Gastroschisis cases from two centers were included. The sensitivity, specificity, positive and negative predictive values (PPV and NPV) were calculated for different EFW cutoffs, as well as EFW and biometric measurement combinations.Seventy gastroschisis cases were analyzed. An EFW<10% had 94% sensitivity, 43% specificity, 33% PPV and 96% NPV for SGA at delivery. Using an EFW cutoff of <5% improved the specificity to 63% and PPV to 41%, but decreased the sensitivity to 88%. Combining an abdominal circumference (AC) or femur length (FL) z-score less than -2 with the total EFW improved the specificity and PPV but decreased the sensitivity.A combination of a small AC or FL along with EFW increases the specificity and PPV, but decreases the sensitivity of predicting SGA.Journal of Perinatology advance online publication, 26 January 2017; doi:10.1038/jp.2016.275.

  View details for DOI 10.1038/jp.2016.275

  View details for PubMedID 28125100

• Prediction of neonatal respiratory distress in pregnancies complicated by fetal lung masses. Prenatal diagnosis Girsen, A. I., Hintz, S. R., Sammour, R., Naqvi, A., El-Sayed, Y. Y., Sherwin, K., Davis, A. S., Chock, V. Y., Barth, R. A., Rubesova, E., Sylvester, K. G., Chitkara, R., Blumenfeld, Y. J. 2017

  Abstract

  The objective of this article is to evaluate the utility of fetal lung mass imaging for predicting neonatal respiratory distress.Pregnancies with fetal lung masses between 2009 and 2014 at a single center were analyzed. Neonatal respiratory distress was defined as intubation and mechanical ventilation at birth, surgery before discharge, or extracorporeal membrane oxygenation (ECMO). The predictive utility of the initial as well as maximal lung mass volume and congenital pulmonary airway malformation volume ratio by ultrasound (US) and magnetic resonance imaging (MRI) was analyzed.Forty-seven fetal lung mass cases were included; of those, eight (17%) had respiratory distress. The initial US was performed at similar gestational ages in pregnancies with and without respiratory distress (26.4 ± 5.6 vs 22.3 ± 3 weeks, p = 0.09); however, those with respiratory distress had higher congenital volume ratio at that time (1.0 vs 0.3, p = 0.01). The strongest predictors of respiratory distress were maximal volume >24.0 cm(3) by MRI (100% sensitivity, 91% specificity, 60% positive predictive value, and 100% negative predictive value) and maximal volume >34.0 cm(3) by US (100% sensitivity, 85% specificity, 54% positive predictive value, and 100% negative predictive value).Ultrasound and MRI parameters can predict neonatal respiratory distress, even when obtained before 24 weeks. Third trimester parameters demonstrated the best positive predictive value. © 2017 John Wiley & Sons, Ltd.

  View details for DOI 10.1002/pd.5002

  View details for PubMedID 28061000

• Predicting mortality in periviable infants-does apgar score help? Ness, A., Sie, L., Foeller, M. E., El-Sayed, Y., Lee, H. C. MOSBY-ELSEVIER. 2017: S198–S199

  View details for Web of Science ID 000414256401281

• Vasa previa and extreme prematurity Yeaton-Massey, A., Girsen, A. I., Mayo, J., Blumenfeld, Y. J., El-Sayed, Y. Y., Shaw, G. M., March Dimes Prematurity Res Ctr MOSBY-ELSEVIER. 2017: S419

  View details for Web of Science ID 000414256403036

• Misoprostol vs. dinoprostone labor induction in nulliparous women at term: outcomes in obese vs. non-obese women Blumenfeld, Y., Faucett, A., El-Sayed, Y., Lee, H. MOSBY-ELSEVIER. 2017: S431

  View details for Web of Science ID 000414256403060

• A Proteomic Clock of Human Pregnancy. American journal of obstetrics and gynecology Aghaeepour, N. n., Lehallier, B. n., Baca, Q. n., Ganio, E. A., Wong, R. J., Ghaemi, M. S., Culos, A. n., El-Sayed, Y. Y., Blumenfeld, Y. J., Druzin, M. L., Winn, V. D., Gibbs, R. S., Tibshirani, R. n., Shaw, G. M., Stevenson, D. K., Gaudilliere, B. n., Angst, M. S. 2017

  Abstract

  Early detection of maladaptive processes underlying pregnancy-related pathologies is desirable, as it will enable targeted interventions ahead of clinical manifestations. The quantitative analysis of plasma proteins features prominently among molecular approaches used to detect deviations from normal pregnancy. However, derivation of proteomic signatures sufficiently predictive of pregnancy-related outcomes has been challenging. An important obstacle hindering such efforts were limitations in assay technology, which prevented the broad examination of the plasma proteome.The recent availability of a highly-multiplexed platform affording the simultaneous measurement of 1,310 plasma proteins opens the door for a more explorative approach. The major aim of this study was to examine whether analysis of plasma collected during gestation of term pregnancy would allow identifying a set of proteins that tightly track gestational age. Establishing precisely-timed plasma proteomic changes during term pregnancy is a critical step in identifying deviations from regular patterns due to fetal and maternal maladaptations. A second aim was to gain insight into functional attributes of identified proteins, and link such attributes to relevant immunological changes.Pregnant women participated in this longitudinal study. In two subsequent subsets of 21 (training cohort) and 10 (validation cohort) women, specific blood specimens were collected during the first (7-14 wks), second (15-20 wks), and third (24-32 wks) trimesters, and 6 wks post-partum for analysis with a highly-multiplexed aptamer-based platform. An elastic net algorithm was applied to infer a proteomic model predicting gestational age. A bootstrapping procedure and piece-wise regression analysis was used to extract the minimum number of proteins required for predicting gestational age without compromising predictive power. Gene ontology analysis was applied to infer enrichment of molecular functions among proteins included in the proteomic model. Changes in abundance of proteins with such functions were linked to immune features predictive of gestational age at the time of sampling in pregnancies delivering at term.An independently validated model consisting of 74 proteins strongly predicted gestational age (p = 3.8x10-14, R = 0.97). The model could be reduced to eight proteins without losing its predictive power (p = 1.7x10-3, R = 0.91). The three top ranked proteins were glypican 3, chorionic somatomammotropin hormone, and granulins. Proteins activating the Janus kinase (JAK) and signal transducer and activator of transcription (STAT) pathway were enriched in the proteomic model, chorionic somatomammotropin hormone being the top ranked protein. Abundance of chorionic somatomammotropin hormone strongly correlated with STAT5 signaling activity in CD4 T cells, the endogenous cell-signaling event most predictive of gestational age.Results indicate that precisely timed changes in the plasma proteome during term pregnancy mirror a "proteomic clock". Importantly, the combined use of several plasma proteins was required for accurate prediction. The exciting promise of such a "clock" is that deviations from its regular chronological profile may assist in the early diagnoses of pregnancy-relate pathologies and point to underlying pathophysiology. Functional analysis of the proteomic model generated the novel hypothesis that somatomammotropin hormone may critically regulate T-cell function during pregnancy.

  View details for PubMedID 29277631

• Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY van Vliet, E. O., Dijkema, G. H., Schuit, E., Heida, K. Y., Roos, C., van der Post, J. A., Parry, E. C., McCowan, L., Lyell, D. J., El-Sayed, Y. Y., Carr, D. B., Clark, A. L., Mahdy, Z. A., Uma, M., Sayin, N. C., Varol, G. F., Mol, B. W., Oudijk, M. A. 2016; 123 (11): 1753-1760

  Abstract

  Preterm birth is the leading cause of neonatal mortality and morbidity in developed countries. Whether continued tocolysis after 48 hours of rescue tocolysis improves neonatal outcome is unproven.To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA).We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour.We selected trials including pregnant women between 24 and 36(6/7)  weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment.The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed.Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95% confidence interval, 95% CI 0.35-5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95% CI 0.16-2.67), necrotising enterocolitis (NEC) (RR 1.15; 95% CI 0.50-2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95% CI 0.51-1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95% CI 0.55-1.01).Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice.Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.

  View details for DOI 10.1111/1471-0528.14249

  View details for Web of Science ID 000384679100004

  View details for PubMedID 27550838

• Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption AMERICAN JOURNAL OF PERINATOLOGY Colon, I., Berletti, M., Garabedian, M. J., Wilcox, N., Williams, K., El-Sayed, Y. Y., Chueh, J. 2016; 33 (7): 696-702

  Abstract

  Objective To evaluate the efficacy and safety of magnesium sulfate in the resolution of vaginal bleeding and contractions in nonsevere placental abruption. Study Design Thirty women between 24 and 34 weeks of gestation diagnosed with nonsevere placental abruption were randomized to receive magnesium sulfate tocolysis or normal saline infusion. The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions. Maternal and neonatal outcomes were also compared. Results Fifteen (50%) women received magnesium sulfate tocolysis and 15 (50%) received intravenous saline. There was no difference in the number of women who were undelivered at 48 hours with resolution of vaginal bleeding and contractions in the magnesium sulfate (80.0%) and saline (66.7%; p-value = 0.68) groups. There were no differences between groups in the gestational age at randomization, time to uterine quiescence, time on study drug, length of hospitalization, days from randomization to delivery, incidence of side effects, or admissions to the neonatal intensive care unit. Conclusions Magnesium sulfate tocolysis did not provide a significant difference in pregnancy prolongation in the management of preterm nonsevere placental abruption. Recruitment goals were not met due to the introduction of the use of magnesium sulfate for neuroprotection.

  View details for DOI 10.1055/s-0036-1571324

  View details for Web of Science ID 000376521500010

  View details for PubMedID 26871905

• Does Time of Delivery Influence the Risk of Neonatal Morbidity? American journal of perinatology Brookfield, K. F., O'Malley, K., El-Sayed, Y. Y., Blumenfeld, Y. J., Butwick, A. J. 2016; 33 (5): 502-509

  Abstract

  Objective To examine whether time of delivery influences the risk of neonatal morbidity among women with singleton pregnancies. Study Design Secondary analysis of data from the Maternal Fetal Medicine Units Network Factor V Leiden Mutation study. We categorized time of delivery as day (07:00-16:59), evening (17:00-23:59), and overnight (midnight-06:59). Severe neonatal morbidity was defined by at least one of the following: respiratory distress syndrome, transient tachypnea of the newborn, sepsis, seizures, neonatal intensive care admission, or a 5-minute APGAR ≤3. We calculated frequencies of severe neonatal morbidity by time of delivery. Multivariate analysis was performed to determine whether time of delivery was independently associated with severe neonatal morbidity. Results Among 4,087 women, 1,917 (46.9%) delivered during the day, 1,140 (27.9%) delivered in the evening, and 1,030 (25.2%) delivered overnight. We observed no significant differences in the rates of neonatal morbidity between delivery time periods (day: 12.3%; evening: 12.8%; overnight: 12.6%; p = 0.9). No significant association was observed between time of delivery and neonatal morbidity after adjustment for maternal, obstetric, and peripartum factors. Conclusion Our findings suggest that time of delivery is not associated with severe neonatal morbidity.

  View details for DOI 10.1055/s-0035-1567891

  View details for PubMedID 26595143

• Labor outcome at extremely advanced maternal age. American journal of obstetrics and gynecology Osmundson, S. S., Gould, J. B., Butwick, A. J., Yeaton-Massey, A., El-Sayed, Y. Y. 2016; 214 (3): 362 e1-7

  Abstract

  Women of advanced maternal age (AMA) are at increased risk for cesarean delivery compared to non-AMA women. However, it is unclear whether how this association is altered by parity and the presence or absence of a trial of labor.We sought to examine modes of delivery and maternal outcomes among AMA women stratified by parity and the presence or absence of a trial of labor.This is a retrospective cohort study of all women delivering singletons births at ≥20 weeks' gestation in the state of California from 2007 through 2011. Data were extracted from maternal discharge data linked to infant birth certificate records. We compared non-AMA women (age 20-34 years, reference group) to AMA women who were classified as follows: age 35-39, 40-44, 45-49, and ≥50 years). The primary outcome was route of delivery (cesarean vs vaginal) stratified by parity and whether a trial of labor occurred (prelabor vs intrapartum cesarean delivery). The association between a trial of labor and perinatal morbidity was also studied.There were 1,346,889 women who met inclusion criteria, which included 181 (0.01%) women who were age ≥50 years at the time of delivery. Overall, 34.7% underwent a cesarean delivery and this risk differed significantly by age group (30.5%, 20-34 years; 40.5%, 35-39 years; 47.3%, 40-44 years; 55.6%, 45-49 years; 62.4%, >50 years). Nulliparous women age ≥50 years were significantly less likely to undergo a trial of labor compared to the reference group (relative risk [RR], 0.44; 95% confidence interval [CI], 0.32-0.62). Furthermore, nulliparous women age ≥50 years were significantly more likely to experience an intrapartum cesarean delivery (RR, 2.61; 95% CI, 1.31-5.20), however the majority (74%) who underwent a trial of labor experienced a vaginal delivery. Compared to the reference group, women age ≥50 years were 5 times more likely to experience severe maternal morbidity (1.7% vs 0.3%; RR, 5.08; 95% CI, 1.65-15.61) and their infants 3 times more likely to require neonatal intensive care unit admission (14.9% vs 5.2%; RR, 3.1; 95% CI, 2.2-4.4), however these outcomes were not associated significantly with having undergone a trial of labor, a cesarean delivery following labor, or a prelabor cesarean delivery. Similar trends were observed among multiparous women.Compared to non-AMA women, women age ≥50 years with a singleton pregnancy experience significantly higher rates of cesarean delivery. However the majority of those who undergo a trial of labor will have a vaginal delivery. Neither a trial of labor nor a prelabor cesarean delivery is significantly associated with maternal or neonatal morbidity. These data support either approach in women of extremely AMA.

  View details for DOI 10.1016/j.ajog.2015.09.103

  View details for PubMedID 26454124

• Early Screening and Treatment of Women with Prediabetes: A Randomized Controlled Trial. American journal of perinatology Osmundson, S. S., Norton, M. E., El-Sayed, Y. Y., Carter, S., Faig, J. C., Kitzmiller, J. L. 2016; 33 (2): 172-179

  Abstract

  To examine whether women with prediabetes benefit from early treatment for gestational diabetes mellitus (GDM).Women with a glycosylated hemoglobin A1C (A1C) of 5.7 to 6.4% at <14 weeks were recruited. Participants were randomized to usual care or treatment for GDM with diet, blood glucose monitoring, and insulin as needed. The primary outcome was a 75-g oral glucose tolerance test at 26 to 28 weeks. Secondary outcomes included cesarean delivery, birthweight, weight gain, and A1C change.Between May 2012 and June 2014, 95 women were enrolled and 83 had data for analysis; 42 were randomized to treatment and 41 to usual care. The groups were similar in baseline characteristics with 40% obese. There was no difference in the primary outcome (treatment 45.2% vs. control 56.1%; relative risk [RR] 0.80; 95% confidence interval [CI] 0.53-1.24) except that women in the treatment group had a significantly lower A1C over time than women in the control group (p = 0.04). Nonobese women (n = 50) treated for GDM experienced a 50% reduction in GDM compared with controls (29.6 vs. 60.9%; RR 0.49; 95% CI 0.25-0.95).Early treatment for women with a first-trimester A1C of 5.7 to 6.4% did not significantly reduce the risk of GDM except in nonobese women.

  View details for DOI 10.1055/s-0035-1563715

  View details for PubMedID 26344009

• Maternal characteristics and mid-pregnancy serum biomarkers as risk factors for subtypes of preterm birth. BJOG : an international journal of obstetrics and gynaecology Jelliffe-Pawlowski, L. L., Baer, R. J., Blumenfeld, Y. J., Ryckman, K. K., O'Brodovich, H. M., Gould, J. B., Druzin, M. L., El-Sayed, Y. Y., Lyell, D. J., Stevenson, D. K., Shaw, G. M., Currier, R. J. 2015; 122 (11): 1484-1493

  Abstract

  To examine the relationship between maternal characteristics, serum biomarkers and preterm birth (PTB) by spontaneous and medically indicated subtypes.Population-based cohort.California, United States of America.From a total population of 1 004 039 live singleton births in 2009 and 2010, 841 665 pregnancies with linked birth certificate and hospital discharge records were included.Characteristics were compared for term and preterm deliveries by PTB subtype using logistic regression and odds ratios adjusted for maternal characteristics and obstetric factors present in final stepwise models and 95% confidence intervals. First-trimester and second-trimester serum marker levels were analysed in a subset of 125 202 pregnancies with available first-trimester and second-trimester serum biomarker results.PTB by subtype.In fully adjusted models, ten characteristics and three serum biomarkers were associated with increased risk in each PTB subtype (Black race/ethnicity, pre-existing hypertension with and without pre-eclampsia, gestational hypertension with pre-eclampsia, pre-existing diabetes, anaemia, previous PTB, one or two or more previous caesarean section(s), interpregnancy interval ≥ 60 months, low first-trimester pregnancy-associated plasma protein A, high second-trimester α-fetoprotein, and high second-trimester dimeric inhibin A). These risks occurred in 51.6-86.2% of all pregnancies ending in PTB depending on subtype. The highest risk observed was for medically indicated PTB <32 weeks in women with pre-existing hypertension and pre-eclampsia (adjusted odds ratio 89.7, 95% CI 27.3-111.2).Our findings suggest a shared aetiology across PTB subtypes. These commonalities point to targets for further study and exploration of risk reduction strategies.Findings suggest a shared aetiology across preterm birth subtypes. Patterns may inform risk reduction efforts.

  View details for DOI 10.1111/1471-0528.13495

  View details for PubMedID 26111589

• Fetofetal Transfusion Syndrome in Monochorionic-Triamniotic Triplets Treated with Fetoscopic Laser Ablation: Report of Two Cases and A Systematic Review. AJP reports Blumenfeld, Y. J., Shamshirsaz, A. A., Belfort, M. A., Hintz, S. R., Moaddab, A., Ness, A., Chueh, J., El-Sayed, Y. Y., Ruano, R. 2015; 5 (2): e153-60

  Abstract

  Objective This study aims to determine the clinical outcomes of monochorionic-triamniotic (MT) pregnancies complicated by severe fetofetal transfusion undergoing laser photocoagulation. Study Design We report two cases of MT triplets complicated by fetofetal transfusion syndrome (FFTS) and a systematic review classifying cases into different subtypes: MT with two donors and one recipient, MT with one donor and two recipients, MT with one donor, one recipient, and one unaffected triplet. The number of neonatal survivors was analyzed based on this classification as well as Quintero staging. Results A total of 26 cases of MT triples complicated by FFTS were analyzed. In 56% of the cases, the FFTS involved all three triplets, 50% of whom had an additional donor and 50% an additional recipient. Among the 24 cases that survived beyond 1 week after the procedure, the average gestational age of delivery was 29.6 weeks, and the average interval from procedure to delivery was 10.1 weeks. The overall neonatal survival rate was 71.7%, with demises occurring equally between donor and recipient triplets. Overall neonatal survival including survival of at least two fetuses occurred with equal frequency between the different groups. Conclusion Significant neonatal survival can be achieved in most cases of MT triplets with FFTS.

  View details for DOI 10.1055/s-0035-1552931

  View details for PubMedID 26495175

  View details for PubMedCentralID PMC4603872

• Serological Targeted Analysis of an ITIH4 Peptide Isoform: A Preterm Birth Biomarker and Its Associated SNP Implications JOURNAL OF GENETICS AND GENOMICS Tan, Z., Hu, Z., Cai, E. Y., Alev, C., Yang, T., Li, Z., Sung, J., El-Sayed, Y. Y., Shaw, G. M., Stevenson, D. K., Butte, A. J., Sheng, G., Sylvester, K. G., Cohen, H. J., Ling, X. B. 2015; 42 (9): 507-510

  View details for DOI 10.1016/j.jgg.2015.06.001

  View details for PubMedID 26408095

• Implementing Mass Cytometry at the Bedside to Study the Immunological Basis of Human Diseases: Distinctive Immune Features in Patients with a History of Term or Preterm Birth CYTOMETRY PART A Gaudilliere, B., Ganio, E. A., Tingle, M., Lancero, H. L., Fragiadakis, G. K., Baca, Q. J., Aghaeepour, N., Wong, R. J., Quaintance, C., El-Sayed, Y. Y., Shaw, G. M., Lewis, D. B., Stevenson, D. K., Nolan, G. P., Angst, M. S. 2015; 87A (9): 817-829

  Abstract

  Single-cell technologies have immense potential to shed light on molecular and biological processes that drive human diseases. Mass cytometry (or Cytometry by Time Of Flight mass spectrometry, CyTOF) has already been employed in clinical studies to comprehensively survey patients' circulating immune system. As interest in the "bedside" application of mass cytometry is growing, the delineation of relevant methodological issues is called for. This report uses a newly generated dataset to discuss important methodological considerations when mass cytometry is implemented in a clinical study. Specifically, the use of whole blood samples versus peripheral blood mononuclear cells (PBMCs), design of mass-tagged antibody panels, technical and analytical implications of sample barcoding, and application of traditional and unsupervised approaches to analyze high-dimensional mass cytometry datasets are discussed. A mass cytometry assay was implemented in a cross-sectional study of 19 women with a history of term or preterm birth to determine whether immune traits in peripheral blood differentiate the two groups in the absence of pregnancy. Twenty-seven phenotypic and 11 intracellular markers were simultaneously analyzed in whole blood samples stimulated with lipopolysaccharide (LPS at 0, 0.1, 1, 10, and 100 ng mL(-1) ) to examine dose-dependent signaling responses within the toll-like receptor 4 (TLR4) pathway. Complementary analyses, grounded in traditional or unsupervised gating strategies of immune cell subsets, indicated that the prpS6 and pMAPKAPK2 responses in classical monocytes are accentuated in women with a history of preterm birth (FDR<1%). The results suggest that women predisposed to preterm birth may be prone to mount an exacerbated TLR4 response during the course of pregnancy. This important hypothesis-generating finding points to the power of single-cell mass cytometry to detect biologically important differences in a relatively small patient cohort. © 2015 International Society for Advancement of Cytometry.

  View details for DOI 10.1002/cyto.a.22720

  View details for Web of Science ID 000360590500009

• Implementing Mass Cytometry at the Bedside to Study the Immunological Basis of Human Diseases: Distinctive Immune Features in Patients with a History of Term or Preterm Birth. Cytometry. Part A : the journal of the International Society for Analytical Cytology Gaudillière, B., Ganio, E. A., Tingle, M., Lancero, H. L., Fragiadakis, G. K., Baca, Q. J., Aghaeepour, N., Wong, R. J., Quaintance, C., El-Sayed, Y. Y., Shaw, G. M., Lewis, D. B., Stevenson, D. K., Nolan, G. P., Angst, M. S. 2015; 87 (9): 817-829

  Abstract

  Single-cell technologies have immense potential to shed light on molecular and biological processes that drive human diseases. Mass cytometry (or Cytometry by Time Of Flight mass spectrometry, CyTOF) has already been employed in clinical studies to comprehensively survey patients' circulating immune system. As interest in the "bedside" application of mass cytometry is growing, the delineation of relevant methodological issues is called for. This report uses a newly generated dataset to discuss important methodological considerations when mass cytometry is implemented in a clinical study. Specifically, the use of whole blood samples versus peripheral blood mononuclear cells (PBMCs), design of mass-tagged antibody panels, technical and analytical implications of sample barcoding, and application of traditional and unsupervised approaches to analyze high-dimensional mass cytometry datasets are discussed. A mass cytometry assay was implemented in a cross-sectional study of 19 women with a history of term or preterm birth to determine whether immune traits in peripheral blood differentiate the two groups in the absence of pregnancy. Twenty-seven phenotypic and 11 intracellular markers were simultaneously analyzed in whole blood samples stimulated with lipopolysaccharide (LPS at 0, 0.1, 1, 10, and 100 ng mL(-1) ) to examine dose-dependent signaling responses within the toll-like receptor 4 (TLR4) pathway. Complementary analyses, grounded in traditional or unsupervised gating strategies of immune cell subsets, indicated that the prpS6 and pMAPKAPK2 responses in classical monocytes are accentuated in women with a history of preterm birth (FDR<1%). The results suggest that women predisposed to preterm birth may be prone to mount an exacerbated TLR4 response during the course of pregnancy. This important hypothesis-generating finding points to the power of single-cell mass cytometry to detect biologically important differences in a relatively small patient cohort. © 2015 International Society for Advancement of Cytometry.

  View details for DOI 10.1002/cyto.a.22720

  View details for PubMedID 26190063

• A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis NEW ENGLAND JOURNAL OF MEDICINE Belfort, M. A., Saade, G. R., Thom, E., Blackwell, S. C., Reddy, U. M., Thorp, J. M., Tita, A. T., Miller, R. S., Peaceman, A. M., McKenna, D. S., Chien, E. K., Rouse, D. J., Gibbs, R. S., El-Sayed, Y. Y., Sorokin, Y., Caritis, S. N., VanDorsten, J. P. 2015; 373 (7): 632-641

  Abstract

  It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes.We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy.A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups.Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).

  View details for DOI 10.1056/NEJMoa1500600

  View details for PubMedID 26267623

• Mode of anaesthesia for preterm Caesarean delivery: secondary analysis from the Maternal-Fetal Medicine Units Network Caesarean Registry†‡. British journal of anaesthesia Butwick, A. J., El-Sayed, Y. Y., Blumenfeld, Y. J., Osmundson, S. S., Weiniger, C. F. 2015; 115 (2): 267-274

  Abstract

  Preterm delivery is often performed by Caesarean section. We investigated modes of anaesthesia and risk factors for general anaesthesia among women undergoing preterm Caesarean delivery.Women undergoing Caesarean delivery between 24(+0) and 36(+6) weeks' gestation were identified from a multicentre US registry. The mode of anaesthesia was classified as neuraxial anaesthesia (spinal, epidural, or combined spinal and epidural) or general anaesthesia. Logistic regression was used to identify patient characteristic, obstetric, and peripartum risk factors associated with general anaesthesia.Within the study cohort, 11 539 women had preterm Caesarean delivery; 9510 (82.4%) underwent neuraxial anaesthesia and 2029 (17.6%) general anaesthesia. In our multivariate model, African-American race [adjusted odds ratio (aOR)=1.9; 95% confidence interval (CI)=1.7-2.2], Hispanic ethnicity (aOR=1.5; 95% CI=1.2-1.8), other race (aOR=1.4; 95% CI=1.1-1.9), and haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia (aOR=2.8; 95% CI=2.2-3.5) were independently associated with receiving general anaesthesia for preterm Caesarean delivery. Women with an emergency Caesarean delivery indication had the highest odds for general anaesthesia (aOR=3.5; 95% CI=3.1-3.9). For every 1 week decrease in gestational age at delivery, the adjusted odds of general anaesthesia increased by 13%.In our study cohort, nearly one in five women received general anaesthesia for preterm Caesarean delivery. Although potential confounding by unmeasured factors cannot be excluded, our findings suggest that early gestational age at delivery, emergent Caesarean delivery indications, hypertensive disease, and non-Caucasian race or ethnicity are associated with general anaesthesia for preterm Caesarean delivery.

  View details for DOI 10.1093/bja/aev108

  View details for PubMedID 25956901

• Maternal serum markers, characteristics and morbidly adherent placenta in women with previa JOURNAL OF PERINATOLOGY Lyell, D. J., Faucett, A. M., Baer, R. J., Blumenfeld, Y. J., Druzin, M. L., El-Sayed, Y. Y., Shaw, G. M., Currier, R. J., Jelliffe-Pawlowski, L. L. 2015; 35 (8): 570-574

  Abstract

  To examine associations with morbidly adherent placenta (MAP) among women with placenta previa.Women with MAP (cases) and previa alone (controls) were identified from a cohort of 236 714 singleton pregnancies with both first and second trimester prenatal screening, and live birth and hospital discharge records; pregnancies with aneuploidies and neural tube or abdominal wall defects were excluded. Logistic binomial regression was used to compare cases with controls.In all, 37 cases with MAP and 699 controls with previa alone were included. Risk for MAP was increased among multiparous women with pregnancy-associated plasma protein-A (PAPP-A) ⩾95th percentile (⩾2.63 multiple of the median (MoM); adjusted OR (aOR) 8.7, 95% confidence interval (CI) 2.8 to 27.4), maternal-serum alpha fetoprotein (MS-AFP) ⩾95th percentile (⩾1.79 MoM; aOR 2.8, 95% CI 1.0 to 8.0), and 1 and ⩾2 prior cesarean deliveries (CDs; aORs 4.4, 95% CI 1.5 to 13.6 and 18.4, 95% CI 5.9 to 57.5, respectively).Elevated PAPP-A, elevated MS-AFP and prior CDs are associated with MAP among women with previa.

  View details for DOI 10.1038/jp.2015.40

  View details for Web of Science ID 000358684100008

• Risk Factors for Prolonged Postpartum Length of Stay Following Cesarean Delivery AMERICAN JOURNAL OF PERINATOLOGY Blumenfeld, Y. J., El-Sayed, Y. Y., Lyell, D. J., Nelson, L. M., Butwick, A. J. 2015; 32 (9): 825-832

  Abstract

  Objective This study aims to identify risk factors for prolonged postpartum length of stays (LOS) after cesarean delivery (CD). Study Design Patients undergoing CD were sourced from a multicenter registry of 19 academic centers between 1999 and 2002 (n = 57,067). Prolonged postpartum LOS was defined as a hospitalization duration ≥ 90th centile. Maternal, antepartum, perioperative, and neonatal variables were compared between women with and without prolonged postpartum LOS. Results The 90th centile for postpartum LOS was 4 days, with 14,954 women experiencing prolonged postpartum LOS. Women with perioperative complications had the highest independent risk for a prolonged postpartum LOS: ileus (adjusted odds ratio [aOR] = 12.28; 95% confidence interval CI = 8.98-16.8); endometritis (aOR = 10.45; 95% CI = 9.51-11.5), and wound complications (aOR = 5.49; 95% CI = 4.54-6.63). Several antepartum, perioperative, and neonatal variables were associated with a prolonged postpartum LOS. Conclusion Perioperative complications had the highest risk for prolonged LOS after CD. Strategies to reduce perioperative complications are needed to decrease the health care burden of prolonged post-CD LOS.

  View details for DOI 10.1055/s-0034-1543953

  View details for Web of Science ID 000358571000004

• Early-onset severe preeclampsia by first trimester pregnancy-associated plasma protein A and total human chorionic gonadotropin. American journal of perinatology Jelliffe-Pawlowski, L. L., Baer, R. J., Currier, R. J., Lyell, D. J., Blumenfeld, Y. J., El-Sayed, Y. Y., Shaw, G. M., Druzin, M. L. 2015; 32 (7): 703-712

  Abstract

  This study aims to evaluate the relationship between early-onset severe preeclampsia and first trimester serum levels of pregnancy-associated plasma protein A (PAPP-A) and total human chorionic gonadotropin (hCG).The association between early-onset severe preeclampsia and abnormal levels of first trimester PAPP-A and total hCG in maternal serum were measured in a sample of singleton pregnancies without chromosomal defects that had integrated prenatal serum screening in 2009 and 2010 (n = 129,488). Logistic binomial regression was used to estimate the relative risk (RR) of early-onset severe preeclampsia in pregnancies with abnormal levels of first trimester PAPP-A or total hCG as compared with controls.Regardless of parity, women with low first trimester PAPP-A or high total hCG were at increased risk for early-onset severe preeclampsia. Women with low PAPP-A (multiple of the median [MoM] ≤ the 10th percentile in nulliparous or ≤ the 5th percentile in multiparous) or high total hCG (MoM ≥ the 90th percentile in nulliparous or ≥ the 95th percentile in multiparous) were at more than a threefold increased risk for early-onset severe preeclampsia (RR, 4.2; 95% confidence interval [CI], 3.0-5.9 and RR, 3.3; 95% CI, 2.1-5.2, respectively).Routinely collected first trimester measurements of PAPP-A and total hCG provide unique risk information for early-onset severe preeclampsia.

  View details for DOI 10.1055/s-0034-1396697

  View details for PubMedID 25519199

• Early-Onset Severe Preeclampsia by First Trimester Pregnancy-Associated Plasma Protein A and Total Human Chorionic Gonadotropin AMERICAN JOURNAL OF PERINATOLOGY Jelliffe-Pawlowski, L. L., Baer, R. J., Currier, R. J., Lyell, D. J., Blumenfeld, Y. J., El-Sayed, Y. Y., Shaw, G. M., Druzin, M. L. 2015; 32 (7): 703-711

  Abstract

  This study aims to evaluate the relationship between early-onset severe preeclampsia and first trimester serum levels of pregnancy-associated plasma protein A (PAPP-A) and total human chorionic gonadotropin (hCG).The association between early-onset severe preeclampsia and abnormal levels of first trimester PAPP-A and total hCG in maternal serum were measured in a sample of singleton pregnancies without chromosomal defects that had integrated prenatal serum screening in 2009 and 2010 (n = 129,488). Logistic binomial regression was used to estimate the relative risk (RR) of early-onset severe preeclampsia in pregnancies with abnormal levels of first trimester PAPP-A or total hCG as compared with controls.Regardless of parity, women with low first trimester PAPP-A or high total hCG were at increased risk for early-onset severe preeclampsia. Women with low PAPP-A (multiple of the median [MoM] ≤ the 10th percentile in nulliparous or ≤ the 5th percentile in multiparous) or high total hCG (MoM ≥ the 90th percentile in nulliparous or ≥ the 95th percentile in multiparous) were at more than a threefold increased risk for early-onset severe preeclampsia (RR, 4.2; 95% confidence interval [CI], 3.0-5.9 and RR, 3.3; 95% CI, 2.1-5.2, respectively).Routinely collected first trimester measurements of PAPP-A and total hCG provide unique risk information for early-onset severe preeclampsia.

  View details for DOI 10.1055/s-0034-1396697

  View details for Web of Science ID 000355418600014

  View details for PubMedID 25519199

• Second-line uterotonics and the risk of hemorrhage-related morbidity. American journal of obstetrics and gynecology Butwick, A. J., Carvalho, B., Blumenfeld, Y. J., El-Sayed, Y. Y., Nelson, L. M., Bateman, B. T. 2015; 212 (5): 642 e1-7

  Abstract

  Uterine atony is a leading cause of postpartum hemorrhage (PPH). Although most cases of PPH respond to first line therapy with uterine massage and oxytocin administration, second line uterotonics including methylergonovine and carboprost are integral for the management of refractory uterine atony. Despite their ubiquitous use, it is uncertain whether the risk of hemorrhage-related morbidity differs in women exposed to methylergonovine or carboprost at Cesarean delivery (CD).We performed a secondary analysis using the Maternal-Fetal Medicine Units Network Cesarean Registry. We identified women who underwent CD and received either methylergonovine or carboprost for refractory uterine atony. The primary outcome was hemorrhage-related morbidity defined as intraoperative or postoperative red blood cells (RBC) transfusion or the need for additional surgical interventions including uterine artery ligation, hypogastric artery ligation, or peripartum hysterectomy for atony. We compared the risk of hemorrhage-related morbidity in those exposed to methylergonovine vs. carboprost. Propensity-score matching was used to account for potential confounders.The study cohort comprised 1,335 women; 870 (65.2%) women received methylergonovine and 465 (34.8%) women received carboprost. After accounting for potential confounders, the risk of hemorrhage-related morbidity was higher in the carboprost group than the methylergonovine group (RR = 1.7; 95% CI = 1.2 - 2.6).In this propensity-score matched analysis, methylergonovine was associated with reduced risk of hemorrhage-related morbidity during CD compared to carboprost. Based on these results, methylergonovine may be a more effective second line uterotonic.

  View details for DOI 10.1016/j.ajog.2015.01.008

  View details for PubMedID 25582104

• Antenatal Corticosteroids for Preterm Premature Rupture of Membranes: Single or Repeat Course? AMERICAN JOURNAL OF PERINATOLOGY Brookfield, K. F., El-Sayed, Y. Y., Chao, L., Berger, V., Naqvi, M., Butwick, A. J. 2015; 32 (6): 537-543

  Abstract

  Objective The aim of this article is to determine the risk of maternal chorioamnionitis and neonatal morbidity in women with preterm premature rupture of membranes (PPROM) exposed to one corticosteroid course versus a single repeat corticosteroid steroid course. Study Design Secondary analysis of a cohort of women with singleton pregnancies and PPROM. The primary outcome was a clinical diagnosis of maternal chorioamnionitis. Using multivariate logistic regression, we controlled for maternal age, race, body mass index, diabetes, gestational age at membrane rupture, preterm labor, and antibiotic administration. Neonatal morbidities were compared between groups controlling for gestational age at delivery. Results Of 1,652 women with PPROM, 1,507 women received one corticosteroid course and 145 women received a repeat corticosteroid course. The incidence of chorioamnionitis was similar between groups (single course = 12.3% vs. repeat course = 11.0%; p = 0.8). Women receiving a repeat corticosteroid course were not at increased risk of chorioamnionitis (adjusted odds ratio, 1.28; 95% confidence interval, 0.69-2.14). A repeat course of steroids was not associated with an increased risk of any neonatal morbidity. Conclusion Compared with a single steroid course, our findings suggest that the risk of maternal chorioamnionitis or neonatal morbidity may not be increased for women with PPROM receiving a repeat corticosteroid course.

  View details for DOI 10.1055/s-0034-1396690

  View details for Web of Science ID 000354342400005

  View details for PubMedID 25545441

• Antenatal corticosteroids for preterm premature rupture of membranes: single or repeat course? American journal of perinatology Brookfield, K. F., El-Sayed, Y. Y., Chao, L., Berger, V., Naqvi, M., Butwick, A. J. 2015; 32 (6): 537-544

  Abstract

  Objective The aim of this article is to determine the risk of maternal chorioamnionitis and neonatal morbidity in women with preterm premature rupture of membranes (PPROM) exposed to one corticosteroid course versus a single repeat corticosteroid steroid course. Study Design Secondary analysis of a cohort of women with singleton pregnancies and PPROM. The primary outcome was a clinical diagnosis of maternal chorioamnionitis. Using multivariate logistic regression, we controlled for maternal age, race, body mass index, diabetes, gestational age at membrane rupture, preterm labor, and antibiotic administration. Neonatal morbidities were compared between groups controlling for gestational age at delivery. Results Of 1,652 women with PPROM, 1,507 women received one corticosteroid course and 145 women received a repeat corticosteroid course. The incidence of chorioamnionitis was similar between groups (single course = 12.3% vs. repeat course = 11.0%; p = 0.8). Women receiving a repeat corticosteroid course were not at increased risk of chorioamnionitis (adjusted odds ratio, 1.28; 95% confidence interval, 0.69-2.14). A repeat course of steroids was not associated with an increased risk of any neonatal morbidity. Conclusion Compared with a single steroid course, our findings suggest that the risk of maternal chorioamnionitis or neonatal morbidity may not be increased for women with PPROM receiving a repeat corticosteroid course.

  View details for DOI 10.1055/s-0034-1396690

  View details for PubMedID 25545441

• Peripartum and neonatal outcomes of small- for- gestational- age infants with gastroschisis PRENATAL DIAGNOSIS Girsen, A. I., Do, S., Davis, A. S., Hintz, S. R., Desai, A. K., Mansour, T., Merritt, T. A., Oshiro, B. T., El-Sayed, Y. Y., Blumenfeld, Y. J. 2015; 35 (5): 477-482

  Abstract

  Neonates with gastroschisis are often small-for-gestational-age (SGA) based on population nomograms. Our objective was to evaluate the effect of SGA on perinatal and neonatal outcomes in cases of gastroschisis.Retrospective study of neonates with prenatally diagnosed gastroschisis from two academic centers between 2008-13. Perinatal and neonatal outcomes of neonates with SGA at birth were compared with appropriate for gestational age (AGA) neonates. The primary composite outcome was defined as any of: neonatal sepsis, short bowel syndrome at discharge, prolonged mechanical ventilation (upper quartile for the cohort), bowel atresia, or death.We identified 112 cases of gastroschisis, 25 of whom (22%) were SGA at birth. There were no differences in adverse peripartum outcomes between SGA and AGA infants. No difference was found in the primary composite neonatal outcome (52% vs. 36%, p=0.21), but SGA infants were more likely to have prolonged mechanical ventilation (44% vs. 22%, p=0.04) and prolonged LOS (52% vs. 22%, p=0.007). After adjusting for GA at delivery, SGA remained associated with prolonged LOS (OR=4.3, CI:1.6 - 11.8).Among infants with gastroschisis, SGA at birth is associated with a 4-fold increase in odds for prolonged LOS, independent of GA. © 2015 John Wiley & Sons, Ltd.

  View details for DOI 10.1002/pd.4562

  View details for Web of Science ID 000353987100011

  View details for PubMedID 25613462

• Second-line uterotonics and the risk of hemorrhage-related morbidity AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Butwick, A. J., Carvalho, B., Blumenfeld, Y. J., El-Sayed, Y. Y., Nelson, L. M., Bateman, B. T. 2015; 212 (5)

  Abstract

  Uterine atony is a leading cause of postpartum hemorrhage (PPH). Although most cases of PPH respond to first line therapy with uterine massage and oxytocin administration, second line uterotonics including methylergonovine and carboprost are integral for the management of refractory uterine atony. Despite their ubiquitous use, it is uncertain whether the risk of hemorrhage-related morbidity differs in women exposed to methylergonovine or carboprost at Cesarean delivery (CD).We performed a secondary analysis using the Maternal-Fetal Medicine Units Network Cesarean Registry. We identified women who underwent CD and received either methylergonovine or carboprost for refractory uterine atony. The primary outcome was hemorrhage-related morbidity defined as intraoperative or postoperative red blood cells (RBC) transfusion or the need for additional surgical interventions including uterine artery ligation, hypogastric artery ligation, or peripartum hysterectomy for atony. We compared the risk of hemorrhage-related morbidity in those exposed to methylergonovine vs. carboprost. Propensity-score matching was used to account for potential confounders.The study cohort comprised 1,335 women; 870 (65.2%) women received methylergonovine and 465 (34.8%) women received carboprost. After accounting for potential confounders, the risk of hemorrhage-related morbidity was higher in the carboprost group than the methylergonovine group (RR = 1.7; 95% CI = 1.2 - 2.6).In this propensity-score matched analysis, methylergonovine was associated with reduced risk of hemorrhage-related morbidity during CD compared to carboprost. Based on these results, methylergonovine may be a more effective second line uterotonic.

  View details for DOI 10.1016/j.ajog.2015.01.008

  View details for Web of Science ID 000353598500025

  View details for PubMedID 25582104

• Correlation of continuous glucose monitoring profiles with pregnancy outcomes in nondiabetic women. American journal of perinatology Sung, J. F., Kogut, E. A., Lee, H. C., Mannan, J. L., Navabi, K., Taslimi, M. M., El-Sayed, Y. Y. 2015; 32 (5): 461-468

  Abstract

  Objective To determine whether hyperglycemic excursions detected by continuous glucose monitoring (CGM) correlate with birth weight percentile and other pregnancy outcomes, and whether CGM correlates better with these outcomes than a single glucose value from a 1-hour glucose challenge test (GCT). Study Design This was a prospective observational study of 55 pregnant patients without preexisting diabetes, who wore a CGM device for up to 7 days, between 24 and 28 weeks' gestation. The area under the curve (AUC) of hyperglycemic excursions above various thresholds (110, 120, 130, 140, and 180 mg/dL) was calculated. These AUC values, and results from a standard 50-g GCT, were correlated with our primary outcome of birth weight percentile, and secondary outcomes of unplanned operative delivery, pregnancy complications, delivery complications, fetal complications, and neonatal complications. Results A consistent correlation was seen between all AUC thresholds and birth weight percentile (r = 0.29, p < 0.05 for AUC-110, -120, -130, and -140; r = 0.25, p = 0.07 for AUC-180). This correlation was stronger than that of 1-hour oral GCT (r =  - 0.02, p = 0.88). There was no association between AUC values and other outcomes. Conclusions Among nondiabetic pregnant patients, hyperglycemic excursions detected by CGM show a stronger correlation to birth weight percentile than blood glucose values obtained 1-hour after a 50-g oral GCT.

  View details for DOI 10.1055/s-0034-1390344

  View details for PubMedID 25262455

• Correlation of Continuous Glucose Monitoring Profiles with Pregnancy Outcomes in Nondiabetic Women AMERICAN JOURNAL OF PERINATOLOGY Sung, J. F., Kogut, E. A., Lee, H. C., Mannan, J. L., Navabi, K., Taslimi, M. M., El-Sayed, Y. Y. 2015; 32 (5): 461-467

  Abstract

  Objective To determine whether hyperglycemic excursions detected by continuous glucose monitoring (CGM) correlate with birth weight percentile and other pregnancy outcomes, and whether CGM correlates better with these outcomes than a single glucose value from a 1-hour glucose challenge test (GCT). Study Design This was a prospective observational study of 55 pregnant patients without preexisting diabetes, who wore a CGM device for up to 7 days, between 24 and 28 weeks' gestation. The area under the curve (AUC) of hyperglycemic excursions above various thresholds (110, 120, 130, 140, and 180 mg/dL) was calculated. These AUC values, and results from a standard 50-g GCT, were correlated with our primary outcome of birth weight percentile, and secondary outcomes of unplanned operative delivery, pregnancy complications, delivery complications, fetal complications, and neonatal complications. Results A consistent correlation was seen between all AUC thresholds and birth weight percentile (r = 0.29, p < 0.05 for AUC-110, -120, -130, and -140; r = 0.25, p = 0.07 for AUC-180). This correlation was stronger than that of 1-hour oral GCT (r =  - 0.02, p = 0.88). There was no association between AUC values and other outcomes. Conclusions Among nondiabetic pregnant patients, hyperglycemic excursions detected by CGM show a stronger correlation to birth weight percentile than blood glucose values obtained 1-hour after a 50-g oral GCT.

  View details for DOI 10.1055/s-0034-1390344

  View details for Web of Science ID 000352807900006

  View details for PubMedID 25262455

• Magnesium sulfate exposure and neonatal intensive care unit admission at term. Journal of perinatology Girsen, A. I., Greenberg, M. B., El-Sayed, Y. Y., LEE, H., Carvalho, B., Lyell, D. J. 2015; 35 (3): 181-185

  Abstract

  Objective:The aim of this study was to investigate the effect of maternal magnesium sulfate (MgSO4) exposure for eclampsia prophylaxis on neonatal intensive care unit (NICU) admission rates for term newborns.Study Design:A secondary analysis of the Maternal-Fetal Medicine Unit Network Cesarean Registry, including primary and repeat cesarean deliveries, and failed and successful trials of labor after cesarean was conducted. Singleton pregnancies among women with preeclampsia and >37 weeks of gestation were included. Pregnancies with uterine rupture, chorioamnionitis and congenital malformations were excluded. Logistic regression analysis was used to determine associations between MgSO4 exposure and NICU admission. P<0.05 was considered statistically significant.Result:Two thousand one hundred and sixty-six term pregnancies of women with preeclampsia were included, of whom 1747 (81%) received MgSO4 for eclampsia prophylaxis and 419 (19%) did not. NICU admission rates were higher among newborns exposed to MgSO4 vs unexposed (22% vs 12%, P<0.001). After controlling for neonatal birth weight, gestational age and maternal demographic and obstetric factors, NICU admission remained significantly associated with antenatal MgSO4 exposure (adjusted odds ratio 1.9, 95% confidence interval 1.3 to 2.6, P<0.001). Newborns exposed to MgSO4 were more likely to have Apgar scores <7 at 1 and 5 min (15% vs 11% unexposed, P=0.01 and 3% vs 0.7% unexposed, P=0.008). There were no significant differences in NICU length of stay (median 5 (range 2 to 91) vs 6 (3 to 15), P=0.5).Conclusion:Antenatal maternal MgSO4 treatment was associated with increased NICU admission rates among exposed term newborns of mothers with preeclampsia. This study highlights the need for studies of maternal MgSO4 administration protocols that optimize maternal and fetal benefits and minimize risks.Journal of Perinatology advance online publication, 16 October 2014; doi:10.1038/jp.2014.184.

  View details for DOI 10.1038/jp.2014.184

  View details for PubMedID 25321647

• Maternal glucose response to betamethasone administration. American journal of perinatology Langen, E. S., Kuperstock, J. L., Sung, J. F., Taslimi, M., Byrne, J., El-Sayed, Y. Y. 2015; 30 (2): 143-148

  Abstract

  Objective This study aims to describe the pattern of maternal glucose response to betamethasone administration using a continuous glucose monitoring system. Study Design A prospective observational trial was conducted among women receiving clinically indicated betamethasone between 24 and 34 weeks gestation. At the time of initial betamethasone administration, a continuous glucose monitoring device was inserted which measured interstitial fluid glucose levels every 5 minutes. Glucose levels were monitored for 7 days, until delivery, or until hospital discharge, whichever came first. We recorded the percentage of time women spent above three glucose thresholds: 110, 144, and 180 mg/dL, respectively. Results A total of 17 women were enrolled at the time of betamethasone administration and data were available for 15 patients. There were 11 nondiabetic and 4 diabetic women. Both diabetic and nondiabetic women had the highest recorded blood glucose readings between 24 and 48 hours after the first injection of betamethasone. In that period, nondiabetic women spent 73, 40, and 17% of the time with blood glucose levels above the 110, 144, and 180 mg/dL thresholds, respectively. Conclusion Nondiabetic women receiving betamethasone manifest significant hyperglycemia after betamethasone administration. If delivery is imminent, maternal glucose response to betamethasone may need to be monitored to prevent possible neonatal hypoglycemia.

  View details for DOI 10.1055/s-0034-1376387

  View details for PubMedID 24915559

• Risk Factors for Prolonged Postpartum Length of Stay Following Cesarean Delivery. American journal of perinatology Blumenfeld, Y. J., El-Sayed, Y. Y., Lyell, D. J., Nelson, L. M., Butwick, A. J. 2015

  Abstract

  Objective This study aims to identify risk factors for prolonged postpartum length of stays (LOS) after cesarean delivery (CD). Study Design Patients undergoing CD were sourced from a multicenter registry of 19 academic centers between 1999 and 2002 (n = 57,067). Prolonged postpartum LOS was defined as a hospitalization duration ≥ 90th centile. Maternal, antepartum, perioperative, and neonatal variables were compared between women with and without prolonged postpartum LOS. Results The 90th centile for postpartum LOS was 4 days, with 14,954 women experiencing prolonged postpartum LOS. Women with perioperative complications had the highest independent risk for a prolonged postpartum LOS: ileus (adjusted odds ratio [aOR] = 12.28; 95% confidence interval CI = 8.98-16.8); endometritis (aOR = 10.45; 95% CI = 9.51-11.5), and wound complications (aOR = 5.49; 95% CI = 4.54-6.63). Several antepartum, perioperative, and neonatal variables were associated with a prolonged postpartum LOS. Conclusion Perioperative complications had the highest risk for prolonged LOS after CD. Strategies to reduce perioperative complications are needed to decrease the health care burden of prolonged post-CD LOS.

  View details for DOI 10.1055/s-0034-1543953

  View details for PubMedID 25594218

• Maternal Glucose Response to Betamethasone Administration AMERICAN JOURNAL OF PERINATOLOGY Langen, E. S., Kuperstock, J. L., Sung, J. F., Taslimi, M., Byrne, J., El-Sayed, Y. Y. 2015; 32 (2): 143-147

  Abstract

  Objective This study aims to describe the pattern of maternal glucose response to betamethasone administration using a continuous glucose monitoring system. Study Design A prospective observational trial was conducted among women receiving clinically indicated betamethasone between 24 and 34 weeks gestation. At the time of initial betamethasone administration, a continuous glucose monitoring device was inserted which measured interstitial fluid glucose levels every 5 minutes. Glucose levels were monitored for 7 days, until delivery, or until hospital discharge, whichever came first. We recorded the percentage of time women spent above three glucose thresholds: 110, 144, and 180 mg/dL, respectively. Results A total of 17 women were enrolled at the time of betamethasone administration and data were available for 15 patients. There were 11 nondiabetic and 4 diabetic women. Both diabetic and nondiabetic women had the highest recorded blood glucose readings between 24 and 48 hours after the first injection of betamethasone. In that period, nondiabetic women spent 73, 40, and 17% of the time with blood glucose levels above the 110, 144, and 180 mg/dL thresholds, respectively. Conclusion Nondiabetic women receiving betamethasone manifest significant hyperglycemia after betamethasone administration. If delivery is imminent, maternal glucose response to betamethasone may need to be monitored to prevent possible neonatal hypoglycemia.

  View details for DOI 10.1055/5-0034-1376387

  View details for Web of Science ID 000348628800005

• Risk factors for obstetric morbidity in patients with uterine atony undergoing Caesarean delivery BRITISH JOURNAL OF ANAESTHESIA Butwick, A. J., Carvalho, B., El-Sayed, Y. Y. 2014; 113 (4): 661-668

  Abstract

  Uterine atony (UA) is recognized as a leading cause of postpartum haemorrhage. However, knowledge of risk factors of haemorrhage-related morbidity among patients diagnosed with UA is uncertain. We investigated risk factors for haemorrhage-related morbidity among patients undergoing Caesarean delivery with UA.We conducted a secondary analysis of data sourced from a 4-yr observational study at 19 US academic centres. Patients with UA were identified based on receiving methylergonovine or carboprost. Our primary outcome (haemorrhage-related morbidity) included a composite of intra- or postpartum transfusion; Caesarean hysterectomy; uterine or hypogastric artery ligation; intensive care admission for: pulmonary oedema, coagulopathy, adult respiratory distress syndrome, postoperative ventilation, or invasive line monitoring.Among 57 182 patients who underwent Caesarean delivery, 2294 (4%) patients developed UA. Haemorrhage-related morbidity occurred in 450 (19.6%) patients with UA. The risk of haemorrhage-related morbidity was increased among African-Americans [adjusted odds ratio (aOR)=2.36; 95% confidence interval (CI)=1.73-3.23], Hispanics (aOR=1.4; 95% CI=1.04-1.9), women with multiple gestations (aOR=1.59; 95% CI=1.06-2.38), placenta praevia (aOR=4.89; 95% CI=3.04-7.87), patients with ASA class III (aOR=1.4; 95 CI=1.03-1.9), or ASA class IV (aOR=5.88; 95% CI=2.48-13.9), exposure to general anaesthesia (GA) (aOR=2.4; 95% CI=1.59-3.62) and combined general and regional anaesthesia (aOR=4.0; 95% CI=2.62-6.09), and ≥2 prior Caesarean deliveries (aOR=1.62; 95% CI=1.1-2.39).Among patients with UA undergoing Caesarean delivery, the risk of haemorrhage-related morbidity is increased in African-Americans, Hispanics, patients with multiple gestations, placenta praevia, ASA class III or IV, ≥2 prior Caesarean deliveries and those undergoing GA.

  View details for DOI 10.1093/bja/aeu150

  View details for Web of Science ID 000343087400019

• Association between maternal characteristics, abnormal serum aneuploidy analytes, and placental abruption. American journal of obstetrics and gynecology Blumenfeld, Y. J., Baer, R. J., Druzin, M. L., El-Sayed, Y. Y., Lyell, D. J., Faucett, A. M., Shaw, G. M., Currier, R. J., Jelliffe-Pawlowski, L. L. 2014; 211 (2): 144 e1-9

  Abstract

  The objective of the study was to examine the association between placental abruption, maternal characteristics, and routine first- and second-trimester aneuploidy screening analytes.The study consisted of an analysis of 1017 women with and 136,898 women without placental abruption who had first- and second-trimester prenatal screening results, linked birth certificate, and hospital discharge records for a live-born singleton. Maternal characteristics and first- and second-trimester aneuploidy screening analytes were analyzed using logistic binomial regression.Placental abruption was more frequent among women of Asian race, age older than 34 years, women with chronic and pregnancy-associated hypertension, preeclampsia, preexisting diabetes, previous preterm birth, and interpregnancy interval less than 6 months. First-trimester pregnancy-associated plasma protein-A of the fifth percentile or less, second-trimester alpha fetoprotein of the 95th percentile or greater, unconjugated estriol of the fifth percentile or less, and dimeric inhibin-A of the 95th percentile or greater were associated with placental abruption as well. When logistic models were stratified by the presence or absence of hypertensive disease, only maternal age older than 34 years (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.0-2.0), pregnancy-associated plasma protein-A of the 95th percentile or less (OR, 1.9; 95% CI, 1.2-3.1), and alpha fetoprotein of the 95th percentile or greater (OR, 2.3; 95% CI, 1.4-3.8) remained statistically significantly associated for abruption.In this large, population-based cohort study, abnormal maternal aneuploidy serum analyte levels were associated with placental abruption, regardless of the presence of hypertensive disease.

  View details for DOI 10.1016/j.ajog.2014.03.027

  View details for PubMedID 24631707

• Association between maternal characteristics, abnormal serum aneuploidy analytes, and placental abruption. American journal of obstetrics and gynecology Blumenfeld, Y. J., Baer, R. J., Druzin, M. L., El-Sayed, Y. Y., Lyell, D. J., Faucett, A. M., Shaw, G. M., Currier, R. J., Jelliffe-Pawlowski, L. L. 2014; 211 (2): 144 e1-9

  View details for DOI 10.1016/j.ajog.2014.03.027

  View details for PubMedID 24631707

• Anticoagulant prescribing practices and anesthetic interventions among anticoagulated pregnant patients: a retrospective study. International journal of obstetric anesthesia Butwick, A., Hass, C., Wong, J., Lyell, D., El-Sayed, Y. 2014; 23 (3): 238-245

  Abstract

  The peripartum management of anticoagulated patients poses important challenges for obstetric anesthesiologists, especially when deciding to perform neuraxial block. However, there is limited evidence evaluating anticoagulant prescribing practices and neuraxial block utilization in this setting. Our objective was to examine peripartum anticoagulant prescribing and anesthetic practices in a cohort of anticoagulated patients receiving subcutaneous enoxaparin, and subcutaneous or intravenous unfractionated heparin.We performed a retrospective study of anticoagulant prescribing patterns and anesthetic interventions among patients receiving enoxaparin and/or unfractionated heparin who delivered at a USA obstetric center over a seven-year period.We identified 101 patients who received enoxaparin and/or unfractionated heparin before delivery. Thirty-nine (38.6%) patients received enoxaparin only, 41 (40.6%) patients received enoxaparin bridged to subcutaneous unfractionated heparin, 11 (10.9%) patients received enoxaparin and were converted to intravenous unfractionated heparin and 10 (9.9%) patients received only subcutaneous unfractionated heparin. The overall rate of neuraxial block utilization was 80.2%. The median [IQR] time-period between the last dose of enoxaparin and neuraxial block was significantly shorter for patients who received only enoxaparin vs. enoxaparin with subcutaneous unfractionated heparin (54h [12-192h] (n=26) vs. 216h [39-504h] (n=23), P=0.04). Among patients who received only subcutaneous unfractionated heparin, the time period between unfractionated heparin and neuraxial block was 24h [19-51h].In this study, the neuraxial block rate was high among patients receiving enoxaparin and/or subcutaneous unfractionated heparin with patients undergoing relatively long periods off anticoagulation. Careful multidisciplinary planning is recommended for the peripartum management of anticoagulated pregnant patients.

  View details for DOI 10.1016/j.ijoa.2014.03.007

  View details for PubMedID 24910353

• Noninvasive prenatal diagnosis in a fetus at risk for methylmalonic acidemia GENETICS IN MEDICINE Gu, W., Koh, W., Blumenfeld, Y. J., El-Sayed, Y. Y., Hudgins, L., Hintz, S. R., Quake, S. R. 2014; 16 (7): 564-567

  View details for DOI 10.1038/gim.2013.194

  View details for Web of Science ID 000338601400012

• Noninvasive prenatal diagnosis in a fetus at risk for methylmalonic acidemia. Genetics in medicine Gu, W., Koh, W., Blumenfeld, Y. J., El-Sayed, Y. Y., Hudgins, L., Hintz, S. R., Quake, S. R. 2014; 16 (7): 564-567

  Abstract

  Purpose:Prenatal diagnosis of fetal Mendelian disorders can benefit from noninvasive approaches using fetal cell-free DNA in maternal plasma. Detecting metabolic disorders before birth can result in immediate treatment postpartum in order to optimize outcome.Methods:We developed a mathematical model and an experimental methodology to analyze the case of a fetus with a 25% risk of inheriting two known mutations in MUT that cause methylmalonic acidemia. To accomplish this, we measured allelic counts at the mutation sites and the fetal fraction from high minor-allele-frequency single-nucleotide polymorphism positions.Results:By counting linked alleles, the test was able to distinguish 11 positive markers from the negative controls and thereby determine whether or not the mutations carried by the parents were inherited by the fetus. For a homozygous fetus, the Z-score of the mutation site was 5.97, whereas the median Z-score of all the linked alleles was 4.56 when all negative (heterozygous) controls had a Z-score <2.5.Conclusion:The application of this methodology for diagnosing methylmalonic acidemia shows that this is a cost-effective and noninvasive approach to diagnosing known mutations related to Mendelian disorders in the fetus.Genet Med advance online publication 9 January 2014Genetics in Medicine (2014); doi:10.1038/gim.2013.194.

  View details for DOI 10.1038/gim.2013.194

  View details for PubMedID 24406457

• Investigation of maternal environmental exposures in association with self-reported preterm birth. Reproductive toxicology Patel, C. J., Yang, T., Hu, Z., Wen, Q., Sung, J., El-Sayed, Y. Y., Cohen, H., Gould, J., Stevenson, D. K., Shaw, G. M., Ling, X. B., Butte, A. J. 2014; 45: 1-7

  Abstract

  Identification of maternal environmental factors influencing preterm birth risks is important to understand the reasons for the increase in prematurity since 1990. Here, we utilized a health survey, the US National Health and Nutrition Examination Survey (NHANES) to search for personal environmental factors associated with preterm birth. 201 urine and blood markers of environmental factors, such as allergens, pollutants, and nutrients were assayed in mothers (range of N: 49-724) who answered questions about any children born preterm (delivery <37 weeks). We screened each of the 201 factors for association with any child born preterm adjusting by age, race/ethnicity, education, and household income. We attempted to verify the top finding, urinary bisphenol A, in an independent study of pregnant women attending Lucile Packard Children's Hospital. We conclude that the association between maternal urinary levels of bisphenol A and preterm birth should be evaluated in a larger epidemiological investigation.

  View details for DOI 10.1016/j.reprotox.2013.12.005

  View details for PubMedID 24373932

• Noninvasive in vivo monitoring of tissue-specific global gene expression in humans. Proceedings of the National Academy of Sciences of the United States of America Koh, W., Pan, W., Gawad, C., Fan, H. C., Kerchner, G. A., Wyss-Coray, T., Blumenfeld, Y. J., El-Sayed, Y. Y., Quake, S. R. 2014; 111 (20): 7361-7366

  Abstract

  Circulating cell-free RNA in the blood provides a potential window into the health, phenotype, and developmental programs of a variety of human organs. We used high-throughput methods of RNA analysis such as microarrays and next-generation sequencing to characterize the global landscape circulating RNA in a cohort of human subjects. By focusing on genes whose expression is highly specific to certain tissues, we were able to identify the relative contributions of these tissues to circulating RNA and to monitor changes in tissue development and health. As one application of this approach, we performed a longitudinal study on pregnant women and analyzed their combined cell-free RNA transcriptomes across all three trimesters of pregnancy and after delivery. In addition to the analysis of mRNA, we observed and characterized noncoding species such as long noncoding RNA and circular RNA transcripts whose presence had not been previously observed in human plasma. We demonstrate that it is possible to track specific longitudinal phenotypic changes in both the mother and the fetus and that it is possible to directly measure transcripts from a variety of fetal tissues in the maternal blood sample. We also studied the role of neuron-specific transcripts in the blood of healthy adults and those suffering from the neurodegenerative disorder Alzheimer's disease and showed that disease specific neural transcripts are present at increased levels in the blood of affected individuals. Characterization of the cell-free transcriptome in its entirety may thus provide broad insights into human health and development without the need for invasive tissue sampling.

  View details for DOI 10.1073/pnas.1405528111

  View details for PubMedID 24799715

• On-time scheduled cesarean delivery start time process-improvement initiative. Obstetrics and gynecology Blumenfeld, Y. J., Riley, E., Hilton, G., Lee, H. C., El-Sayed, Y. Y., Druzin, M. L. 2014; 123: 138S-9S

  Abstract

  Cesarean deliveries comprise approximately 30% of all births, many of which are scheduled. Given the labile nature of labor and delivery units, scheduled cesarean deliveries are often delayed. Our aim was to improve on-time scheduled cesarean delivery start times.A multidisciplinary team (obstetrician-gynecologist, nursing, anesthesia, and hospital administration) met to review scheduled cesarean delivery data, identify logistic barriers to on-time starts, and develop a plan to improve cesarean delivery start times. After identifying possible barriers to on-time starts, the following process was instituted: planned preoperative visit 1-2 days before scheduled cesarean delivery, mandatory submission of History & Physical and consent forms by the time of the preoperative visit, and initial preparation of the first scheduled patient for cesaren delivery by nighttime nursing before morning change of shift. The process launched on March 1, 2013. Data from scheduled cesarean deliveries 6 months before and 3 months after the initiative were reviewed and analyzed.Of 1,298 total cesarean deliveries, 423 were scheduled, defined as cesarean delivery scheduled at least 24 hours in advance (300 before and 123 after the initiative). Sixty-four of 300 scheduled cesarean deliveries (21.3%) were on time before compared with 67 of 123 (54.5%) after the initiative began (P<.001). Among delayed cases, there was no difference in the average delay time between those before and after the initiative (55.7 compared with 54.4 minutes P=.93); however, 50.7% of cases were either on time or delayed by 15 minutes or less before the initiative compared with 69.9% of cases after (P<.001).A multidisciplinary initiative significantly increased scheduled cesarean delivery on-time start times.

  View details for DOI 10.1097/01.AOG.0000447113.07157.f3

  View details for PubMedID 24770007

• In response. Anesthesia and analgesia Macario, A., Carvalho, B., Tan, J. M., Sultan, P., El-Sayed, Y. Y. 2014; 118 (4): 884-885

  View details for DOI 10.1213/ANE.0000000000000114

  View details for PubMedID 24651247

• Oral misoprostol versus vaginal dinoprostone for labor induction in nulliparous women at term. Journal of perinatology Faucett, A. M., Daniels, K., Lee, H. C., El-Sayed, Y. Y., Blumenfeld, Y. J. 2014; 34 (2): 95-99

  Abstract

  Objective:To compare the efficacy of oral misoprostol to vaginal dinoprostone for labor induction in nulliparous women.Study design:Admissions for labor induction from January 2008 to December 2010 were reviewed. Patients receiving oral misoprostol were compared with those receiving vaginal dinoprostone. The primary outcome was time from induction agent administration to vaginal delivery. Secondary outcomes included vaginal delivery within 24 h, mode of delivery and maternal and fetal outcomes.Result:A total of 680 women were included: 483 (71%) received vaginal dinoprostone and 197 (29%) received oral misoprostol. Women who received oral misoprostol had a shorter interval to vaginal delivery (27.2 vs 21.9 h, P<0.0001) and were more likely to deliver vaginally in <24 h (47% vs 64%, P=0.001). There was no increase in the rate of cesarean delivery or adverse maternal or neonatal outcomes.Conclusion:Labor induction with oral misoprostol resulted in shorter time to vaginal delivery without increased adverse outcomes in nulliparous women.

  View details for DOI 10.1038/jp.2013.133

  View details for PubMedID 24157494

• High rate of preterm birth in pregnancies complicated by rheumatoid arthritis. American journal of perinatology Langen, E. S., Chakravarty, E. F., Liaquat, M., El-Sayed, Y. Y., Druzin, M. L. 2014; 31 (1): 9-14

  Abstract

  Objective To describe the outcomes of pregnancies complicated by rheumatoid arthritis (RA) and to estimate potential associations between disease characteristics and pregnancy outcomes.Study Design We reviewed all pregnancies complicated by RA delivered at our institution from June 2001 through June 2009. Fisher exact tests were used to calculate odds ratios. Univariable regression was performed using STATA 10.1 (StataCorp, College Station, TX). A p value of ≤ 0.05 was considered statistically significant.Results Forty-six pregnancies in 40 women were reviewed. Sixty percent of pregnancies had evidence of disease flare and 28% delivered prior to 37 weeks. We did not identify associations between preterm birth and active disease at conception or during pregnancy. In univariate analysis, discontinuation of medication because of pregnancy was associated with a significantly earlier gestational age at delivery (362/7 versus 383/7 weeks, p = 0.022).Conclusion Women with RA may be at higher risk for preterm delivery.

  View details for DOI 10.1055/s-0033-1333666

  View details for PubMedID 23359233

• High Rate of Preterm Birth in Pregnancies Complicated by Rheumatoid Arthritis AMERICAN JOURNAL OF PERINATOLOGY Langen, E. S., Chakravarty, E. F., Liaquat, M., El-Sayed, Y. Y., Druzin, M. L. 2014; 31 (1): 9-13

  Abstract

  Objective To describe the outcomes of pregnancies complicated by rheumatoid arthritis (RA) and to estimate potential associations between disease characteristics and pregnancy outcomes.Study Design We reviewed all pregnancies complicated by RA delivered at our institution from June 2001 through June 2009. Fisher exact tests were used to calculate odds ratios. Univariable regression was performed using STATA 10.1 (StataCorp, College Station, TX). A p value of ≤ 0.05 was considered statistically significant.Results Forty-six pregnancies in 40 women were reviewed. Sixty percent of pregnancies had evidence of disease flare and 28% delivered prior to 37 weeks. We did not identify associations between preterm birth and active disease at conception or during pregnancy. In univariate analysis, discontinuation of medication because of pregnancy was associated with a significantly earlier gestational age at delivery (362/7 versus 383/7 weeks, p = 0.022).Conclusion Women with RA may be at higher risk for preterm delivery.

  View details for DOI 10.1055/s-0033-1333666

  View details for Web of Science ID 000329362900002

  View details for PubMedID 23359233

• Isolated umbilical vein varix with a poor outcome despite close fetal surveillance. Journal of ultrasound in medicine Brookfield, K. F., Osmundson, S. S., Chetty, S., Chueh, J., Blumenfeld, Y. J., Barth, R. A., El-Sayed, Y. Y. 2013; 32 (9): 1680-1682

  View details for DOI 10.7863/ultra.32.9.1680

  View details for PubMedID 23980233

• Brief report: a cost analysis of neuraxial anesthesia to facilitate external cephalic version for breech fetal presentation. Anesthesia and analgesia Carvalho, B., Tan, J. M., Macario, A., El-Sayed, Y. Y., Sultan, P. 2013; 117 (1): 155-159

  Abstract

  BACKGROUND:In this study, we sought to determine whether neuraxial anesthesia to facilitate external cephalic version (ECV) increased delivery costs for breech fetal presentation.METHODS:Using a computer cost model, which considers possible outcomes and probability uncertainties at the same time, we estimated total expected delivery costs for breech presentation managed by a trial of ECV with and without neuraxial anesthesia.RESULTS:From published studies, the average probability of successful ECV with neuraxial anesthesia was 60% (with individual studies ranging from 44% to 87%) compared with 38% (with individual studies ranging from 31% to 58%) without neuraxial anesthesia. The mean expected total delivery costs, including the cost of attempting/performing ECV with anesthesia, equaled $8931 (2.5th-97.5th percentile prediction interval $8541-$9252). The cost was $9207 (2.5th-97.5th percentile prediction interval $8896-$9419) if ECV was attempted/performed without anesthesia. The expected mean incremental difference between the total cost of delivery that includes ECV with anesthesia and ECV without anesthesia was $-276 (2.5th-97.5th percentile prediction interval $-720 to $112).CONCLUSION:The total cost of delivery in women with breech presentation may be decreased (up to $720) or increased (up to $112) if ECV is attempted/performed with neuraxial anesthesia compared with ECV without neuraxial anesthesia. Increased ECV success with neuraxial anesthesia and the subsequent reduction in breech cesarean delivery rate offset the costs of providing anesthesia to facilitate ECV.

  View details for DOI 10.1213/ANE.0b013e31828e5bc7

  View details for PubMedID 23592608

• A Cost Analysis of Neuraxial Anesthesia to Facilitate External Cephalic Version for Breech Fetal Presentation ANESTHESIA AND ANALGESIA Carvalho, B., Tan, J. M., Macario, A., El-Sayed, Y. Y., Sultan, P. 2013; 117 (1): 155-159

  Abstract

  BACKGROUND:In this study, we sought to determine whether neuraxial anesthesia to facilitate external cephalic version (ECV) increased delivery costs for breech fetal presentation.METHODS:Using a computer cost model, which considers possible outcomes and probability uncertainties at the same time, we estimated total expected delivery costs for breech presentation managed by a trial of ECV with and without neuraxial anesthesia.RESULTS:From published studies, the average probability of successful ECV with neuraxial anesthesia was 60% (with individual studies ranging from 44% to 87%) compared with 38% (with individual studies ranging from 31% to 58%) without neuraxial anesthesia. The mean expected total delivery costs, including the cost of attempting/performing ECV with anesthesia, equaled $8931 (2.5th-97.5th percentile prediction interval $8541-$9252). The cost was $9207 (2.5th-97.5th percentile prediction interval $8896-$9419) if ECV was attempted/performed without anesthesia. The expected mean incremental difference between the total cost of delivery that includes ECV with anesthesia and ECV without anesthesia was $-276 (2.5th-97.5th percentile prediction interval $-720 to $112).CONCLUSION:The total cost of delivery in women with breech presentation may be decreased (up to $720) or increased (up to $112) if ECV is attempted/performed with neuraxial anesthesia compared with ECV without neuraxial anesthesia. Increased ECV success with neuraxial anesthesia and the subsequent reduction in breech cesarean delivery rate offset the costs of providing anesthesia to facilitate ECV.

  View details for DOI 10.1213/ANE.0b013e31828e5bc7

  View details for Web of Science ID 000326512300025

• Effect of magnesium sulfate exposure on term neonates JOURNAL OF PERINATOLOGY Greenberg, M. B., Penn, A. A., Whitaker, K. R., KOGUT, E. A., El-Sayed, Y. Y., Caughey, A. B., Lyell, D. J. 2013; 33 (3): 188-193

  Abstract

  To compare neonatal intensive care unit and special care unit (NICU) admission rates between term neonates exposed to antenatal magnesium sulfate (MS) and those unexposed.We performed a retrospective cohort study of all singleton neonates ≥37 weeks born to women with pre-eclampsia from August 2006 to July 2008. Cases were defined by antenatal exposure to MS and controls by absence of MS exposure. The primary outcome was NICU admission. Data were analyzed via univariable and multivariable regression analyses.In all, 28 (14.7%) out of 190 MS-exposed neonates ≥37 weeks were admitted to the NICU, compared with 4 (5.4%) of 74 non-exposed neonates (P=0.04). This association persisted after controlling for potential confounding variables including severe pre-eclampsia and cesarean delivery (AOR 3.69, 1.13 to 11.99). NICU admission was associated in a dose-dependent relationship with total hours and mean dose of MS exposure. Number needed to harm with MS was 11 per NICU admission. Among neonates admitted to the NICU, MS-exposed were more likely to require fluid and nutritional support than unexposed neonates (60.7 vs 0%, P=0.04), and trended toward more frequent requirement for respiratory support and greater length of stay.In term neonates, MS exposure may be associated independently with NICU admission in a dose-dependent relationship. Requirements for fluid and nutritional support are common in this group, likely due to feeding difficulties in exposed neonates. Assessment of acute care needs among all neonates exposed to MS for maternal eclampsia prophylaxis should be considered.

  View details for DOI 10.1038/jp.2012.95

  View details for Web of Science ID 000315664700005

  View details for PubMedID 22836873

• Peripartum outcomes and anaesthetic management of parturients with moderate to complex congenital heart disease or pulmonary hypertension ANAESTHESIA Maxwell, B. G., El-Sayed, Y. Y., Riley, E. T., Carvalho, B. 2013; 68 (1): 52-59

  Abstract

  We performed a retrospective cohort analysis of pregnancies among women with moderate to complex congenital heart disease or pulmonary hypertension over a 12-year period, resulting in a cohort of 107 cases in 65 women. Neuraxial analgesia or anaesthesia was provided in 84%, 89% and 95% of spontaneous vaginal, operative vaginal and caesarean deliveries, respectively. The caesarean delivery rate was 43% compared to our institution average of 27% over the same period (p = 0.02), and 38% had operative vaginal deliveries compared to a 10.5% institution rate (p < 0.01). Invasive monitoring was used in 28% of all deliveries. There were one maternal and two neonatal deaths. This study provides detailed anaesthetic and peripartum management of women with congenital heart disease, a patient population in whom evidence-based practice and data are largely lacking. We observed a predominance of neuraxial anaesthetic techniques, increased caesarean and operative delivery rates, and favourable maternal and neonatal outcomes. Multicentre studies and registries to compare anaesthetic and obstetric management strategies further and delineate risk factors for adverse outcomes are required.

  View details for DOI 10.1111/anae.12058

  View details for Web of Science ID 000312304000012

  View details for PubMedID 23121251

• Utilization of available prenatal screening and diagnosis: effects of the California screen program JOURNAL OF PERINATOLOGY Blumenfeld, Y. J., Taylor, J., Lee, H. C., Hudgins, L., Sung, J. F., El-Sayed, Y. Y. 2012; 32 (12): 907-912

  Abstract

  In 2009, the California Genetic Disease Branch introduced an aneuploidy screening program allowing Medi-Cal (state insured) patients access to state-sponsored first-trimester screening. The objective of this study was to assess the effect of greater access to prenatal screening on available resources at a single center.Data of prenatal screening and diagnostic procedures performed 4 months before the introduction of the program were compared with those of 12 months following the introduction.Between December 2008 and March 2010, 7689 women underwent first trimester screening, 1286 underwent amniocentesis and 398 underwent chorionic villus sampling. When a comparison was made between the 4 months before and the 12 months after the program's introduction, a greater number of nuchal translucency (NT) examinations was seen to have been performed (384 per month vs 513 per month, P=0.001). Prenatal diagnostic procedures did not increase, but a greater proportion was performed for positive screen results.Introduction of the California screening program was associated with increased NT procedures and fewer invasive procedures for advanced maternal age.

  View details for DOI 10.1038/jp.2012.8

  View details for Web of Science ID 000311831700002

  View details for PubMedID 22402484

• Detecting Prenatal Microdeletions Non-Invasively: Case of a 22q11.2 Deletion Annual Meeting of the Association-for-Molecular-Pathology Gu, W., Fan, H., Blumenfeld, Y., El-Sayed, Y., Quake, S. ELSEVIER SCIENCE INC. 2012: 638–38

  View details for Web of Science ID 000310178600021

• Diagnosis and Management of Arrest Disorders: Duration to Wait SEMINARS IN PERINATOLOGY El-Sayed, Y. Y. 2012; 36 (5): 374-378

  Abstract

  To assess the thresholds of normal and protracted labor in contemporary US parturients. Select studies addressing first- and second-stage labor duration among contemporary cohorts of women in the United States were reviewed. Particular emphasis was placed on the work of the Consortium on Safe Labor. Duration of labor appears longer today than in the past. For both nulliparous and multiparous women, labor may take >6 hours to progress from 4 to 5 cm and >3 hours to progress from 5 to 6 cm of dilation. A cervical dilation of 6 cm appears to be a better landmark for the start of the active phase. The 95th percentile for duration of the second stage in a nulliparous woman with conduction anesthesia is closer to 4 hours. Current data on first and second stages of labor allow for an opportunity to reconsider traditionally accepted thresholds of normal and protracted labor, and thus affect consequent labor management paradigms.

  View details for DOI 10.1053/j.semperi.2012.04.022

  View details for Web of Science ID 000309628900012

  View details for PubMedID 23009971

• Non-invasive prenatal measurement of the fetal genome NATURE Fan, H. C., Gu, W., Wang, J., Blumenfeld, Y. J., El-Sayed, Y. Y., Quake, S. R. 2012; 487 (7407): 320-?

  Abstract

  The vast majority of prenatal genetic testing requires invasive sampling. However, this poses a risk to the fetus, so one must make a decision that weighs the desire for genetic information against the risk of an adverse outcome due to hazards of the testing process. These issues are not required to be coupled, and it would be desirable to discover genetic information about the fetus without incurring a health risk. Here we demonstrate that it is possible to non-invasively sequence the entire prenatal genome. Our results show that molecular counting of parental haplotypes in maternal plasma by shotgun sequencing of maternal plasma DNA allows the inherited fetal genome to be deciphered non-invasively. We also applied the counting principle directly to each allele in the fetal exome by performing exome capture on maternal plasma DNA before shotgun sequencing. This approach enables non-invasive exome screening of clinically relevant and deleterious alleles that were paternally inherited or had arisen as de novo germline mutations, and complements the haplotype counting approach to provide a comprehensive view of the fetal genome. Non-invasive determination of the fetal genome may ultimately facilitate the diagnosis of all inherited and de novo genetic disease.

  View details for DOI 10.1038/nature11251

  View details for Web of Science ID 000306506500033

  View details for PubMedID 22763444

  View details for PubMedCentralID PMC3561905

• Rectus muscle and visceral peritoneum closure at cesarean delivery and intraabdominal adhesions 78th Annual Meeting of the Pacific-Coast-Obstetrical-and-Gynecological-Society Lyell, D. J., Caughey, A. B., Hu, E., Blumenfeld, Y., El-Sayed, Y. Y., Daniels, K. MOSBY-ELSEVIER. 2012

  Abstract

  The purpose of this study was to evaluate the effect of the rectus muscle and visceral peritoneum closure at cesarean delivery on adhesions.We performed a secondary analysis of a prospective cohort study of women who underwent first repeat cesarean delivery. Surgeons scored the severity and location of adhesions. Records were abstracted to assess previous surgical techniques.The original cohort included 173 patients. Rectus muscle closure was associated with fewer combined filmy and dense adhesions overall (27.5% vs 46%; P = .04) and fewer dense adhesions overall (17.5% vs 46%; P = .001; adjusted odds ratio, [aOR], 0.24; 95% confidence interval [CI], 0.09-0.65), particularly from fascia to omentum (aOR, 0.08; 95% CI, 0.007-0.82). Visceral peritoneum closure was associated with increased dense fascia-to-omentum adhesions (aOR, 15.78; 95% CI, 1.81-137.24).Closure of the rectus muscles at cesarean delivery may reduce adhesions, and visceral peritoneum closure may increase them. Surgical techniques at cesarean delivery should be assessed independently, because they may have opposite effects on adhesion formation.

  View details for DOI 10.1016/j.ajog.2012.02.033

  View details for Web of Science ID 000304442900029

  View details for PubMedID 22463952

• Trends in Cesarean Delivery for Twin Births in the United States: 1995-2008 Reply OBSTETRICS AND GYNECOLOGY Lee, H. C., Gould, J. B., Boscardin, W. J., El-Sayed, Y. Y., Blumenfeld, Y. J. 2012; 119 (3): 658-659

  View details for DOI 10.1097/AOG.0b013e318248f682

  View details for Web of Science ID 000300637400029

• Continuous Glucose Monitoring During Pregnancy in Women With Polycystic Ovary Syndrome OBSTETRICS AND GYNECOLOGY Sung, J. F., Taslimi, M. M., El-Sayed, Y. Y. 2012; 119 (2): 383-384

  View details for Web of Science ID 000299604300035

  View details for PubMedID 22270301

• Maternal glucose response to betamethasone administration 32nd Annual Pregnancy Meeting of the Society-for-Maternal-Fetal-Medicine (SMFM) Langen, E., Lewis, J., Sung, J., Taslimi, M., Byrne, J., El-Sayed, Y. MOSBY-ELSEVIER. 2012: S98–S98

  View details for Web of Science ID 000298889900194

• Profiling maternal plasma cell-free RNA by RNA-sequencing: a comprehensive approach 32nd Annual Pregnancy Meeting of the Society-for-Maternal-Fetal-Medicine (SMFM) Koh, W., Fan, C., Blumenfeld, Y., Wong, R., El-Sayed, Y., Kogut, E., Quake, S. MOSBY-ELSEVIER. 2012: S324–S324

  View details for Web of Science ID 000298889900725

• Plasma proteomic profiles in preterm labor (PTL) and preterm premature rupture of membranes (PPROM) 32nd Annual Pregnancy Meeting of the Society-for-Maternal-Fetal-Medicine (SMFM) Sung, J., Whitin, J., Yang, Q., Madan, A., El-Sayed, Y. MOSBY-ELSEVIER. 2012: S224–S224

  View details for Web of Science ID 000298889900491

• Trends in Cesarean Delivery for Twin Births in the United States 1995-2008 OBSTETRICS AND GYNECOLOGY Lee, H. C., Gould, J. B., Boscardin, W. J., El-Sayed, Y. Y., Blumenfeld, Y. J. 2011; 118 (5): 1095-1101

  Abstract

  To estimate trends and risk factors for cesarean delivery for twins in the United States.This was a cross-sectional study in which we calculated cesarean delivery rates for twins from 1995 to 2008 using National Center for Health Statistics data. We compared cesarean delivery rates by year and for vertex compared with breech presentation. The order of presentation for a given twin pair could not be determined from the available records and therefore analysis was based on individual discrete twin data. Multivariable logistic regression was used to estimate independent risk factors, including year of birth and maternal factors, for cesarean delivery.Cesarean delivery rates for twin births increased steadily from 53.4% to 75.0% in 2008. Rates rose for the breech twin category (81.5%-92.1%) and the vertex twin category (45.1%-68.2%). The relative increase in the cesarean delivery rate for preterm and term neonates was similar. After risk adjustment, there was an average increase noted in cesarean delivery of 5% each year during the study period (risk ratio 1.05, 95% confidence interval 1.04-1.05).Cesarean delivery rates for twin births increased dramatically from 1995 to 2008. This increase is significantly higher than that which could be explained by an increase in cesarean delivery for breech presentation of either the presenting or second twin.

  View details for DOI 10.1097/AOG.0b013e3182318651

  View details for Web of Science ID 000296292600018

  View details for PubMedID 22015878

  View details for PubMedCentralID PMC3202294

• Decreased Circulating Soluble Tie2 Levels in Preeclampsia May Result from Inhibition of Vascular Endothelial Growth Factor (VEGF) Signaling JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM Sung, J. F., Fan, X., Dhal, S., Dwyer, B. K., Jafari, A., El-Sayed, Y. Y., Druzin, M. L., Nayak, N. R. 2011; 96 (7): E1148-E1152

  Abstract

  Recent studies have found dysregulation in circulating levels of a number of angiogenic factors and their soluble receptors in preeclampsia. In this study, we examined the mechanism of production of soluble Tie2 (sTie2) and its potential connection to the failure of vascular remodeling in preeclamptic pregnancies.Serum samples were collected prospectively from 41 pregnant subjects at five different time points throughout pregnancy. Five of these subjects developed preeclampsia. For a second study, serum and placental samples were collected at delivery from preeclamptic and gestational age-matched controls. We examined serum sTie2 levels, and angiopoietin 1, angiopoietin 2, and Tie2 mRNA expression and localization in placental samples from the central basal plate area. We also examined the effects of vascular endothelial growth factor (VEGF) and a matrix metalloproteinase (MMP) inhibitor on proteolytic shedding of Tie2 in uterine microvascular endothelial cells.Serum sTie2 levels were significantly lower in preeclamptic subjects starting at 24-28 wk of gestation and continued to be lower through the time of delivery. In culture experiments, VEGF treatment significantly increased sTie2 levels in conditioned media, whereas the MMP inhibitor completely blocked this increase, suggesting that VEGF-induced Tie2 release is MMP dependent.Our data suggest, for the first time, an interaction between VEGF and Tie2 in uterine endothelial cells and a potential mechanism for the decrease in circulating sTie2 levels in preeclampsia, likely through inhibition of VEGF signaling. Further studies on VEGF-Tie2 interactions during pregnancy should provide new insights into the mechanisms underlying the failure of vascular remodeling in preeclampsia and other pregnancy complications.

  View details for DOI 10.1210/jc.2011-0063

  View details for Web of Science ID 000292454500015

  View details for PubMedID 21525162

  View details for PubMedCentralID PMC3135205

• Neonatal medical admission in a term and late-preterm cohort exposed to magnesium sulfate 31st Annual Western Conference on Perinatal Research Greenberg, M. B., Penn, A. A., Thomas, L. J., El-Sayed, Y. Y., Caughey, A. B., Lyell, D. J. MOSBY-ELSEVIER. 2011

  Abstract

  The purpose of this study was to estimate neonatal intensive care unit and special care unit (NICU) admission rates and care needs among term and late-preterm neonates who are exposed to antenatal magnesium sulfate.We conducted a retrospective cohort study of all singleton neonates of ≥35 weeks' gestation who were exposed immediately antenatally to magnesium sulfate for maternal eclampsia prophylaxis (August 2006 through July 2008).Fifty-one of 242 neonates (21.1%) who, at ≥35 weeks' gestation, had been exposed to antenatal magnesium sulfate were admitted to the NICU. NICU admission was associated in a dose-dependent fashion with total hours and mean dose of magnesium: >12 hours exposure, odds ratio, 2.81 (95% confidence interval, 1.31-6.03); >30 g exposure, odds ratio, 2.59 (95% confidence interval, 1.22-5.51). Infants in NICU who were diagnosed with hypermagnesemia required fluid or nutritional support more frequently (91.3% vs 39.3%; P < .001) than those without hypermagnesemia.Antenatal magnesium sulfate exposure is associated with NICU admission among term and late-preterm neonates in a dose-dependent fashion. Fluid and nutritional assistance commonly are needed in this cohort.

  View details for DOI 10.1016/j.ajog.2011.01.046

  View details for PubMedID 21376302

• MR imaging in cases of antenatal suspected appendicitis - a meta-analysis JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE Blumenfeld, Y. J., Wong, A. E., Jafari, A., Barth, R. A., El-Sayed, Y. Y. 2011; 24 (3): 485-488

  Abstract

  Appendicitis is the most common surgical emergency in pregnancy. Acute appendicitis is often difficult to diagnose clinically, and concerns regarding antenatal CT imaging limit its use resulting in high false negative rates at laparotomy. MRI has recently been reported as a reasonable alternative to CT imaging in cases of suspected appendicitis. Our objective was to perform a meta-analysis of recently published data regarding the utility of MR imaging in cases of antenatal suspected acute appendicitis.We searched the PubMed database using keywords 'MRI', 'appendicitis', and 'pregnancy'. Five case series describing the role of MRI in cases of antenatal appendicitis were included. The sensitivity, specificity, positive, and negative predictive values were calculated.Two hundred twenty-nine patients were included in the study. In the first analysis in which non-diagnostic scans were excluded, the sensitivity, specificity, positive and negative predictive values of MRI for diagnosing appendicitis were 95.0%, 99.9%, 90.4%, and 99.5%, respectively. In the second analysis, which included non-diagnostic scans, the sensitivity, specificity, positive and negative predictive values were 90.5%, 98.6%, 86.3%, and 99.0%, respectivelyMR imaging may be useful in cases of suspected antenatal appendicitis. Data are still limited and larger prospective studies are necessary to confirm this finding.

  View details for DOI 10.3109/14767058.2010.506227

  View details for Web of Science ID 000286993000020

  View details for PubMedID 20695758

• Decreased Circulating sTie2 Levels in Preeclampsia May Involve Inhibition of VEGF Signaling Sung, J. F., Fan, X., Dwyer, B. K., Dhal, S., El-Sayed, Y. Y., Druzin, M. L., Nayak, N. R. SAGE PUBLICATIONS INC. 2011: 79A–79A

  View details for Web of Science ID 000291721700029

• Diagnositic utility of ultrasound and MRI in women with placenta previa and placental invasion 31st Annual Scientific Meeting of the Society-of-Maternal-Fetal-Medicine (SMFM) Langen, E., El-Sayed, Y., Druzin, M., Park, M., Lee, H. MOSBY-ELSEVIER. 2011: S137–S137

  View details for Web of Science ID 000285927500334

• Maternal morbidity in pregnancies complicated by abnormal placentation 31st Annual Scientific Meeting of the Society-of-Maternal-Fetal-Medicine (SMFM) Langen, E., El-Sayed, Y., Druzin, M., Park, M., Lee, H. MOSBY-ELSEVIER. 2011: S57–S57

  View details for Web of Science ID 000285927500107

• The Effect of Preterm Premature Rupture of Membranes on Neonatal Mortality Rates 30th Annual Clinical Meeting of the Society-for-Maternal-Fetal-Medicine Blumenfeld, Y. J., Lee, H. C., Gould, J. B., Langen, E. S., Jafari, A., El-Sayed, Y. Y. LIPPINCOTT WILLIAMS & WILKINS. 2010: 1381–86

  Abstract

  To estimate the effect of preterm premature rupture of membranes (PROM) on neonatal mortality.A cross-sectional study using a state perinatal database (California Perinatal Quality Care Collaborative) was performed. Prenatal data, including ruptured membranes, corticosteroid administration, maternal age, maternal race, maternal hypertension, mode of delivery, and prenatal care, were recorded. Mortality rates were compared for neonates born between 24 and 34 weeks of gestation without preterm PROM to those with recent (less than 18 hours before delivery) and prolonged (more than 18 hours before delivery) preterm PROM. Neonatal sepsis rates were also examined.Neonates born between 24 0/7 and 34 0/7 weeks of gestation from 127 California neonatal intensive care units between 2005 and 2007 were included (N=17,501). When analyzed by 2-week gestational age groups, there were no differences in mortality rates between those born with and without membrane rupture before delivery. The presence of prolonged preterm PROM was associated with decreased mortality at 24 to 26 weeks of gestation (18% compared with 31% for recent preterm PROM; odds ratio [OR] 1.79; confidence interval [CI] 1.25-2.56) but increased mortality at 28 to 30 weeks of gestation (4% compared with 3% for recent preterm PROM; OR 0.44; CI 0.22, 0.88) when adjusted for possible confounding factors. Sepsis rates did not differ between those with recent or prolonged preterm PROM at any gestational age.The presence of membrane rupture before delivery was not associated with increased neonatal mortality in any gestational age group. The effects of a prolonged latency period were not consistent across gestational ages.

  View details for DOI 10.1097/AOG.0b013e3181fe3d28

  View details for Web of Science ID 000284491000021

  View details for PubMedID 21099606

• Regional anesthesia for external cephalic version: its time has come JOURNAL OF PERINATOLOGY Caughey, A. B., El-Sayed, Y. Y. 2010; 30 (9): 569-570

  View details for DOI 10.1038/jp.2010.89

  View details for Web of Science ID 000281388500001

  View details for PubMedID 20802508

• Maternal-fetal and neonatal pharmacogenomics: a review of current literature JOURNAL OF PERINATOLOGY Blumenfeld, Y. J., Reynolds-May, M. F., Altman, R. B., El-Sayed, Y. Y. 2010; 30 (9): 571-579

  Abstract

  Pharmacogenomics, the study of specific genetic variations and their effect on drug response, will likely give rise to many applications in maternal-fetal and neonatal medicine; yet, an understanding of these applications in the field of obstetrics and gynecology and neonatal pediatrics is not widespread. This review describes the underpinnings of the field of pharmacogenomics and summarizes the current pharmacogenomic inquiries in relation to maternal-fetal medicine-including studies on various fetal and neonatal genetic cytochrome P450 (CYP) enzyme variants and their role in drug toxicities (for example, codeine metabolism, sepsis and selective serotonin reuptake inhibitor (SSRI) toxicity). Potential future directions, including alternative drug classification, improvements in drug efficacy and non-invasive pharmacogenomic testing, will also be explored.

  View details for DOI 10.1038/jp.2009.183

  View details for Web of Science ID 000281388500002

  View details for PubMedID 19924131

  View details for PubMedCentralID PMC3098749

• Oral Misoprostol and Vaginal Isosorbide Mononitrate for Labor Induction A Randomized Controlled Trial 29th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Collingham, J. P., Fuh, K. C., Caughey, A. B., Pullen, K. M., Lyell, D. J., El-Sayed, Y. Y. LIPPINCOTT WILLIAMS & WILKINS. 2010: 121–26

  Abstract

  To estimate whether vaginal isosorbide mononitrate, added to oral misoprostol for cervical ripening and labor induction, shortens time to vaginal delivery.A prospective, randomized trial was conducted. Women scheduled for labor induction between 32 and 42 weeks and with unfavorable cervices (modified Bishop score 6 or lower) were randomized to receive oral misoprostol every 4 hours, up to four doses, with or without isosorbide mononitrate every 6 hours, up to two doses. A strict protocol was used, including timing of oxytocin use and amniotomy. Side effects were assessed 6 hours after study initiation. One hundred forty-two patients were required to detect a change in time to vaginal delivery of 4 hours (alpha=.05 and beta=.20). Data were analyzed by intent to treat. Student's t, chi square, Fisher's exact, and Mann-Whitney tests were used where appropriate with P< or =.05 deemed significant.One hundred fifty-six women were randomized; three were excluded after randomization. Seventy-eight women received misoprostol, and 78 received misoprostol with isosorbide mononitrate. Demographic characteristics were similar between groups. The time to vaginal delivery was not reduced when isosorbide mononitrate was added to misoprostol. Cesarean delivery rates and contraction and fetal heart rate abnormalities were similar between groups. Side effects were also similar between groups, except that women given isosorbide mononitrate experienced headaches more often. Neonatal outcomes were similar between groups.The addition of vaginal isosorbide mononitrate to oral misoprostol for cervical ripening and labor induction did not reduce time to vaginal delivery and was associated with a greater incidence of headache.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00374621.I.

  View details for Web of Science ID 000278998600019

  View details for PubMedID 20567177

• Single- versus double-layer hysterotomy closure at primary caesarean delivery and bladder adhesions BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY Blumenfeld, Y. J., Caughey, A. B., El-Sayed, Y. Y., Daniels, K., Lyell, D. J. 2010; 117 (6): 690-694

  Abstract

  To determine the association between single-layer (one running suture) and double-layer (second layer or imbricating suture) hysterotomy closure at primary caesarean delivery and subsequent adhesion formation.A secondary analysis from a prospective cohort study of women undergoing first repeat caesarean section.Department of Obstetrics and Gynecology, Stanford University, Stanford, CA, USA.One hundred and twenty-seven pregnant women undergoing first repeat caesarean section.Patient records were reviewed to identify whether primary caesarean hysterotomies were closed with a single or double layer. Data were analysed by Fisher's exact tests and multivariable logistic regression.Prevalence rate of pelvic and abdominal adhesions.Of the 127 women, primary hysterotomy closure was single layer in 56 and double layer in 71. Single-layer hysterotomy closure was associated with bladder adhesions at the time of repeat caesarean (24% versus 7%, P = 0.01). Single-layer closure was associated in this study with a seven-fold increase in the odds of developing bladder adhesions (odds ratio, 6.96; 95% confidence interval, 1.72-28.1), regardless of other surgical techniques, previous labour, infection and age over 35 years. There was no association between single-layer closure and other pelvic or abdominal adhesions.Primary single-layer hysterotomy closure may be associated with more frequent bladder adhesions during repeat caesarean deliveries. The severity and clinical implications of these adhesions should be assessed in large prospective trials.

  View details for DOI 10.1111/j.1471-0528.2010.02529.x

  View details for Web of Science ID 000276509100007

  View details for PubMedID 20236104

• Daily Compared With 8-Hour Gentamicin for the Treatment of Intrapartum Chorioamnionitis A Randomized Controlled Trial 28th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Lyell, D. J., Pullen, K., Fuh, K., Zamah, M., Caughey, A. B., Benitz, W., El-Sayed, Y. Y. LIPPINCOTT WILLIAMS & WILKINS. 2010: 344–49

  Abstract

  To assess whether daily gentamicin is as effective as 8-hour gentamicin for the treatment of intrapartum chorioamnionitis.Women with a clinical diagnosis of chorioamnionitis between 32 and 42 weeks of gestation were randomly assigned in labor to receive either daily gentamicin (5 mg/kg intravenously (IV), then 2 placebo doses IV after 8 and 16 hours) or 8-hour gentamicin (2 mg/kg IV, then 1.5 mg/kg IV after 8 and 16 hours). Both groups received ampicillin (2 grams IV every 6 hours for a total of four doses). Patients who underwent cesarean delivery also received clindamycin (900 mg IV every 8 hours, for a total of three doses). The primary outcome was treatment success, defined by resolution of chorioamnionitis after 16 hours of treatment without development of endometritis. One hundred twenty-six patients were required to have 95% confidence that daily gentamicin is at worst 15% inferior to 8-hour dosing with an alpha of .05 and a beta of 0.2.One hundred twenty-six women were enrolled, of whom 63 received daily gentamicin and 63 received 8-hour gentamicin. One patient was excluded from data analysis. Baseline maternal and obstetric characteristics were similar between groups except for longer mean duration of ruptured membranes in the 8-hour group (679+/-514 compared with 469+/-319 minutes; P =.03). Treatment success was equal between groups (94% daily gentamicin compared with 89% 8-hour gentamicin, P =.53). There were no differences in maternal or neonatal morbidities, including neonatal sepsis and newborn hearing screen.Daily and 8-hour gentamicin appear equally effective for the treatment of intrapartum chorioamnionitis.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00185991.I.

  View details for Web of Science ID 000273872500020

  View details for PubMedID 20093909

• Cost-effectiveness of external cephalic version for term breech presentation BMC PREGNANCY AND CHILDBIRTH Tan, J. M., Macario, A., Carvalho, B., Druzin, M. L., El-Sayed, Y. Y. 2010; 10

  Abstract

  External cephalic version (ECV) is recommended by the American College of Obstetricians and Gynecologists to convert a breech fetus to vertex position and reduce the need for cesarean delivery. The goal of this study was to determine the incremental cost-effectiveness ratio, from society's perspective, of ECV compared to scheduled cesarean for term breech presentation.A computer-based decision model (TreeAge Pro 2008, Tree Age Software, Inc.) was developed for a hypothetical base case parturient presenting with a term singleton breech fetus with no contraindications for vaginal delivery. The model incorporated actual hospital costs (e.g., $8,023 for cesarean and $5,581 for vaginal delivery), utilities to quantify health-related quality of life, and probabilities based on analysis of published literature of successful ECV trial, spontaneous reversion, mode of delivery, and need for unanticipated emergency cesarean delivery. The primary endpoint was the incremental cost-effectiveness ratio in dollars per quality-adjusted year of life gained. A threshold of $50,000 per quality-adjusted life-years (QALY) was used to determine cost-effectiveness.The incremental cost-effectiveness of ECV, assuming a baseline 58% success rate, equaled $7,900/QALY. If the estimated probability of successful ECV is less than 32%, then ECV costs more to society and has poorer QALYs for the patient. However, as the probability of successful ECV was between 32% and 63%, ECV cost more than cesarean delivery but with greater associated QALY such that the cost-effectiveness ratio was less than $50,000/QALY. If the probability of successful ECV was greater than 63%, the computer modeling indicated that a trial of ECV is less costly and with better QALYs than a scheduled cesarean. The cost-effectiveness of a trial of ECV is most sensitive to its probability of success, and not to the probabilities of a cesarean after ECV, spontaneous reversion to breech, successful second ECV trial, or adverse outcome from emergency cesarean.From society's perspective, ECV trial is cost-effective when compared to a scheduled cesarean for breech presentation provided the probability of successful ECV is > 32%. Improved algorithms are needed to more precisely estimate the likelihood that a patient will have a successful ECV.

  View details for DOI 10.1186/1471-2393-10-3

  View details for Web of Science ID 000296428000001

  View details for PubMedID 20092630

  View details for PubMedCentralID PMC2826287

• Second-Trimester Serum Cytokines in Women Who Develop Spontaneous Preterm Labor at Less than 28 Weeks' Gestation versus Term Labor AMERICAN JOURNAL OF PERINATOLOGY Yang, Q., El Sayed, Y., Shaw, G. M., Fu, J., Schilling, J., Madan, A. 2010; 27 (1): 31-36

  Abstract

  We sought to determine if there is a relationship between serum concentrations of cytokines and the development of preterm labor. A panel of 28 cytokines was measured using the multiplex assay in serum samples collected between 15 and 18 weeks' gestation from women who developed spontaneous preterm labor and delivered between 24 and 28 weeks' gestation (N = 25) and from women who delivered at term (>or=37 weeks; N = 25). Sixteen of the 28 cytokines measured were detected. Except for vascular endothelial growth factor, which showed a trend toward a significant increase in patients who developed preterm labor, there was no difference in cytokine levels between groups in preterm labor and in term labor. Serum cytokine changes in women who develop spontaneous preterm labor possibly occur in the period between 18 weeks' gestation and the onset of labor.

  View details for DOI 10.1055/s-0029-1234037

  View details for Web of Science ID 000273825200006

  View details for PubMedID 19644787

• Do ruptured membranes remote from term affect neonatal mortality? 30th Annual Clinical Meeting of the Society-for-Maternal-Fetal-Medicine Blumenfeld, Y., Lee, H., Gould, J., Langen, E., Jafari, A., El-Sayed, Y. MOSBY-ELSEVIER. 2009: S167–S168

  View details for Web of Science ID 000279559500436

• Comprehensive maternal-fetal pharmacogenomics - a novel pharmacogenomic thumbprint 30th Annual Clinical Meeting of the Society-for-Maternal-Fetal-Medicine Blumenfeld, Y., Fan, C., Sangkuhl, K., Altman, R., El-Sayed, Y., Quake, S. MOSBY-ELSEVIER. 2009: S254–S254

  View details for Web of Science ID 000279559500695

• Hepatocyte growth factor (HGF) is upregulated at the fetomaternal junction in preeclamptic placentas 30th Annual Clinical Meeting of the Society-for-Maternal-Fetal-Medicine Sung, J., Fan, X., Nguyen, T., Dhal, S., El-Sayed, Y., Druzin, M., Nayak, N. MOSBY-ELSEVIER. 2009: S269–S269

  View details for Web of Science ID 000279559500740

• The effect of ruptured membranes on early neonatal sepsis 30th Annual Clinical Meeting of the Society-for-Maternal-Fetal-Medicine Blumenfeld, Y., Lee, H., Gould, J., Greenberg, M., Sung, J., El-Sayed, Y. MOSBY-ELSEVIER. 2009: S168–S168

  View details for Web of Science ID 000279559500437

• Multiple Cytokine Profile in Plasma and Amniotic Fluid in a Mouse Model of Pre-Term Labor AMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY Yang, Q., El-Sayed, Y., Rosenberg-Hasson, Y., Hirschberg, D. L., Nayak, N. R., Schilling, J., Madan, A. 2009; 62 (5): 339-347

  Abstract

  The rate of pre-term birth in the United States continues to rise despite several interventions. Induction of pro-inflammatory cytokines and chemokines has been implicated in the activation of the cascade of events resulting in pre-term labor. To date, no comprehensive panel of the cytokine profile in PTL has been published.To address cytokine profiles in pre-term labor, levels of 19 plasma and amniotic fluid cytokines were measured using a multiplex immunoassay in an inflammation-induced murine model of pre-term labor.Pro-inflammatory mediators, RANTES, KC, IL-6, and IL-12p40 were increased by 3 hr and remained high at 15 hr. Concentrations of KC, IL-6, IL-1beta, and MIP-1alpha were increased in the amniotic fluid at 15 hr. Plasma levels of anti-inflammatory mediators IL-10 and IL-13 at 15 hr were unchanged and decreased respectively.These results suggest that stimulation of several pro-inflammatory cytokines occurs very early in the cascade of events and remains increased, whereas anti-inflammatory cytokines are either unchanged or decreased until the onset of delivery in an inflammation-induced mouse model of pre-term labor.

  View details for DOI 10.1111/j.1600-0897.2009.00743.x

  View details for Web of Science ID 000270610900009

  View details for PubMedID 19811468

• Microfluidic digital PCR enables rapid prenatal diagnosis of fetal aneuploidy 29th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Fan, H. C., Blumenfeld, Y. J., El-Sayed, Y. Y., Chueh, J., Quake, S. R. MOSBY-ELSEVIER. 2009

  Abstract

  The purpose of this study was to demonstrate that digital polymerase chain reaction (PCR) enables rapid, allele independent molecular detection of fetal aneuploidy.Twenty-four amniocentesis and 16 chorionic villus samples were used for microfluidic digital PCR analysis. Three thousand and sixty PCR reactions were performed for each of the target chromosomes (X, Y, 13, 18, and 21), and the number of single molecule amplifications was compared to a reference. The difference between target and reference chromosome counts was used to determine the ploidy of each of the target chromosomes.Digital PCR accurately identified all cases of fetal trisomy (3 cases of trisomy 21, 3 cases of trisomy 18, and 2 cases of triosmy 13) in the 40 specimens analyzed. The remaining specimens were determined to have normal ploidy for the chromosomes tested.Microfluidic digital PCR allows detection of fetal chromosomal aneuploidy utilizing uncultured amniocytes and chorionic villus tissue in less than 6 hours.

  View details for DOI 10.1016/j.ajog.2009.03.002

  View details for Web of Science ID 000265253800029

  View details for PubMedID 19375573

• Successful pregnancy and cesarean delivery via noninvasive ventilation in mitochondrial myopathy JOURNAL OF PERINATOLOGY Yuan, N., El-Sayed, Y. Y., Ruoss, S. J., Riley, E., Enns, G. M., Robinson, T. E. 2009; 29 (2): 166-167

  Abstract

  We report a case study of a 22-year-old woman with mitochondrial thymidine kinase 2 deficiency and chronic respiratory failure due to severe neuromuscular weakness requiring noninvasive positive pressure ventilation (NIPPV) since 12 years of age. During pregnancy and cesarean delivery, she was successfully supported with NIPPV. A multidisciplinary team approach should be used in pregnant patients with these disorders with specific attention to management of pulmonary complications, selection of route of delivery, anesthesia, and analgesia.

  View details for DOI 10.1038/jp.2008.178

  View details for Web of Science ID 000263492700016

  View details for PubMedID 19177045

• Maintenance Nifedipine Tocolysis Compared With Placebo A Randomized Controlled Trial 28th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Lyell, D. J., Pullen, K. M., Mannan, J., Chitkara, U., Druzin, M. L., Caughey, A. B., El-Sayed, Y. Y. LIPPINCOTT WILLIAMS & WILKINS. 2008: 1221–26

  Abstract

  To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.A prospective, randomized double-blind, multicenter study was conducted. After successful tocolysis, patients were randomly assigned to receive 20 mg nifedipine or an identical-appearing placebo every 4-6 hours until 37 weeks of gestation. The primary outcome was attainment of 37 weeks of gestation. Patients were enrolled between 24 weeks and 34 weeks if they had six or fewer contractions per hour, intact membranes, and less than 4 cm cervical dilation. Exclusion criteria were placental abruption or previa, fetal anomaly incompatible with life, or maternal medical contraindication to tocolysis. Sixty-six patients were required for 80% power to detect a 50% reduction in birth before 37 weeks, with a two-tailed alpha of 0.05. Data were analyzed by intent to treat.Seventy-one patients were randomly assigned. Two patients were excluded after randomization and one was lost to follow-up. Thirty-five patients received placebo, and 33 received nifedipine. There were no maternal demographic differences between groups; the placebo group was significantly more dilated and effaced at study entry. There was no difference in attainment of 37 weeks (39% nifedipine compared with 37% placebo, P>.91), mean delay of delivery (33.5+/-19.9 days nifedipine compared with 32.6+/-21.4 days placebo, P=.81) or delay of delivery for greater than 48 hours or 1, 2, 3, or 4 weeks. Neonatal outcomes were similar between groups.When compared with placebo, maintenance nifedipine tocolysis did not confer a large reduction in preterm birth or improvement in neonatal outcomes.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00185952I.

  View details for Web of Science ID 000261316200006

  View details for PubMedID 19037029

• DIGITAL PCR ENABLES RAPID PRENATAL DIAGNOSIS OF FETAL ANEUPLOIDY 29th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Fan, C., Blumenfeld, Y., Chueh, J., El-Sayed, Y., Quake, S. MOSBY-ELSEVIER. 2008: S30–S30

  View details for DOI 10.1016/j.ajog.2008.09.089

  View details for Web of Science ID 000262205700066

• RANDOMIZED CLINICAL TRIAL OF CERVICAL RIPENING AND LABOR INDUCTION USING ORAL MISOPROSTOL WITH OR WITHOUT INTRAVAGINAL ISOSORBIDE MONONITRATE 29th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Collingham, J., Fuh, K., Caughey, A., Pullen, K., Lyell, D., Druzin, M., Kogut, E., El-Sayed, Y. MOSBY-ELSEVIER. 2008: S53–S53

  View details for DOI 10.1016/j.ajog.2008.09.172

  View details for Web of Science ID 000262205700146

• Two cases of cholestasis in the first trimester of pregnancy after ovarian hyperstimulation FERTILITY AND STERILITY Zamah, A. M., El-Sayed, Y. Y., Milki, A. A. 2008; 90 (4)

  Abstract

  To report two cases of early onset cholestasis of pregnancy associated with IVF and ovarian hyperstimulation syndrome.Case report.University-based IVF program.Two patients with first-trimester cholestasis of pregnancy after IVF that was associated with ovarian hyperstimulation syndrome.In vitro fertilization-embryo transfer, management of hyperstimulation syndrome, and cholestasis of pregnancy.Clinical pregnancy course and pregnancy outcomes.The first patient was treated with ursodeoxycholic acid and had resolution of symptoms within the first trimester. The second patient initially had a miscarriage but did redevelop cholestasis of pregnancy in the latter stages of a pregnancy resulting from frozen embryo transfer.We report two cases of intrahepatic cholestasis of pregnancy in the first trimester of pregnancies by IVF in association with ovarian hyperstimulation syndrome and markedly elevated maternal serum estrogen levels. Early recognition of this unusual clinical presentation allows for optimal pregnancy management by both the reproductive endocrinologist and the obstetrician.

  View details for DOI 10.1016/j.fertnstert.2007.08.072

  View details for PubMedID 18929050

• Perinatal outcomes among Asian-white interracial couples 28th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Nystrom, M. J., Caughey, A. B., Lyell, D. J., Druzin, M. L., El-Sayed, Y. Y. MOSBY-ELSEVIER. 2008

  Abstract

  To investigate whether perinatal outcomes among interracial Asian-white couples are different than among Asian-Asian and white-white couples.This was a retrospective study of Asian, white, and Asian-white couples delivered at the Lucile Packard Children's Hospital from 2000-2005. Asian-white couples were subdivided into white-mother/Asian-father or Asian-mother/white-father. Perinatal outcomes included gestational diabetes, hypertensive disorders of pregnancy, preterm delivery, birth weight >4000 g and <2500 g, and cesarean delivery.In the study population of 868 Asian-white, 3226 Asian, and 5575 white couples there were significant outcome differences. Compared with white couples, Asian-white couples had an increased incidence of gestational diabetes (aOR 2.4 for white-mother/Asian-father and aOR 2.6 for Asian-mother/white-father), though not as high as Asian couples (aOR 4.7). Asian-white couples had larger babies (median 3360 g for Asian-mother/white-father and 3320 g for white-mother/Asian-father vs 3210 g for Asian, P < .001), but only Asian-mother/white-father couples had an increased rate of cesarean delivery (aOR 1.3-2.0).Significant differences in perinatal outcomes exist between Asian, white, and interracial Asian-white couples.

  View details for DOI 10.1016/j.ajog.2008.06.065

  View details for Web of Science ID 000260045700021

  View details for PubMedID 18928981

• Population trends in cesarean delivery for breech presentation in the United States, 1997-2003 Annual Meeting of the Pediatric-Academic-Societies/Society-of-Pediatric-Research Lee, H. C., El-Sayed, Y. Y., Gould, J. B. MOSBY-ELSEVIER. 2008

  Abstract

  The objective of the study was to determine whether cesarean delivery for breech has increased in the United States.We calculated cesarean rates for term singletons in breech/malpresentation from 1997 to 2003 using National Center for Health Statistics data. We compared rates by sociodemographic groups and state. Multivariable logistic regression models were constructed to see whether factors associated with cesarean delivery differed over time.Breech cesarean rates increased overall from 83.8% to 85.1%. There was a significant increase in rates for most sociodemographic groups. There was little to no increase for mothers younger than 30 years old. There was wide variability in rates by state, 61.6-94.2% in 1997. Higher breech incidence correlated with lower cesarean rates, suggesting potential state bias in reporting breech.In the United States, breech infants are predominantly born by cesarean. There was a small increase in this trend from 1998 to 2002. There is wide variability by state, which is not explained by sociodemographic patterns and may be due to reporting differences.

  View details for DOI 10.1016/j.ajog.2007.11.059

  View details for Web of Science ID 000257205200021

  View details for PubMedID 18295181

  View details for PubMedCentralID PMC2533265

• Antibiotic prophylaxis for prevention of postpartum perineal wound complications - A randomized controlled trial 27th Annual Meeting of the Society-of-Maternal-Fetal-Medicine Duggal, N., Mercado, C., Daniels, K., Bujor, A., Caughey, A. B., El-Sayed, Y. Y. LIPPINCOTT WILLIAMS & WILKINS. 2008: 1268–73

  Abstract

  To estimate whether prophylactic antibiotics at the time of repair of third- or fourth-degree perineal tears after vaginal delivery prevent wound infection and breakdown.This was a prospective, randomized, placebo-controlled study. Patients who sustained third- or fourth-degree perineal tears after a vaginal delivery were recruited for the study. Each patient was given a single intravenous dose of a second-generation cephalosporin (cefotetan or cefoxitin) or placebo before repair of third- or fourth-degree perineal tears. Obstetricians and patients were blinded to study drug. The perineum was inspected for evidence of infection or breakdown at discharge from the hospital and at 2 weeks postpartum. Primary end points were gross disruption or purulent discharge at site of perineal repair by 2 weeks postpartum.One hundred forty-seven patients were recruited for the study. Of these, 83 patients received placebo and 64 patients received antibiotics. Forty patients (27.2%) did not return for their 2-week appointment. Of the patients seen at 2 weeks postpartum, 4 of 49 (8.2%) patients who received antibiotics and 14 of 58 (24.1%) patients who received placebo developed a perineal wound complication (P=.037). There were no differences between groups in parity, incidence of diabetes, operative delivery, or third-degree compared with fourth-degree lacerations.By 2 weeks postpartum, patients who received prophylactic antibiotics at the time of third- or fourth-degree laceration repair had a lower rate of perineal wound complications than patients who received placebo.ClinicalTrials.gov, www.clincaltrials.gov, NCT00186082.I.

  View details for Web of Science ID 000256191400003

  View details for PubMedID 18515507

• Concealed maternal blood glucose excursions correlate with birth weight centile. Journal of diabetes science and technology Taslimi, M. M., Navabi, K., Acosta, R., Helmer, A., El-Sayed, Y. Y. 2008; 2 (3): 456-460

  Abstract

  The objective of this study was to test the hypothesis that maternal blood glucose excursions correlate with deviation from optimized birth weight.Patients were recruited for 3-day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation. Patients and caregivers were blinded to CGM results. The magnitude and duration of blood glucose (BG) excursions were measured as a "glycemia index." A customized birth weight centile was calculated.Twenty-three patients consented, 21 completed the study: 5 diabetic and 16 nondiabetic individuals. The duration of CGM was 72 (+/-7.2) hours, and each patient performed self-BG monitoring >/=3 times per day. All diabetic and 10 nondiabetic patients had several measured BG excursions above 130 mg/dl. A positive correlation was observed between birth weight centile and glycemia index above 130 (p < 0.03); the trend persisted for nondiabetic patients alone (p < 0.05). No significant correlation was noted between birth weight centile and average 3-day CGM values, 3-day fasting BG, average 3-day self-BG monitoring values, or diabetes screening BG value.The glycemia index has a better correlation with birth weight centile than BG measured by conventional methods in a mixed diabetic and nondiabetic population. Fetal exposure to maternal blood glucose excursions correlates positively with fetal growth, even in nondiabetic patients with apparently normal glucose tolerance.

  View details for PubMedID 19885210

• Alpha-thalassemia and limb defects in humans: A possible hypoxic mechanism? Adam, M. P., Chueh, J., El-Sayed, Y. Y., Stenzel, A., Vogel, H., Weaver, D. D., Hoyme, H. E. WILEY-BLACKWELL. 2008: 315–15

  View details for Web of Science ID 000256655000057

• Once daily vs. 8-hour gentamicin dosing for chorioamnionitis 28th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Pullen, K., Zamah, M., Fuh, K., Caughey, A., Benitz, W., Lyell, D., El-Sayed, Y. MOSBY-ELSEVIER. 2007: S68–S68

  View details for Web of Science ID 000251708500204

• Pre-eclampsia and nasal CPAP: Part 1. Early intervention with nasal CPAP in pregnant women with risk-factors for pre-eclampsia: Preliminary findings SLEEP MEDICINE Guillerninault, C., Palombini, L., Poyares, D., Takaoka, S., Huynh, N. T., El-Sayed, Y. 2007; 9 (1): 9-14

  Abstract

  Pre-eclampsia is a leading cause of maternal-fetal morbidity and mortality. Significant overlap exists between the risk factors for pre-eclampsia and sleep-disordered breathing. Nasal continuous positive airway pressure (CPAP) has been proposed as therapy for pre-eclampsia. This prospective, longitudinal study was designed to characterize sleep-related breathing patterns in pregnant women with pre-eclampsia risk factors, and to describe the effects of early nasal CPAP therapy in these patients.Twelve pregnant women with pre-eclampsia risk factors underwent polysomnography to characterize sleep-related breathing abnormalities and baseline blood pressure determination. Patients with airflow-limitation underwent nasal CPAP titration and were treated with optimal pressures. Periodic assessments of CPAP compliance and tolerance, sleep quality, and blood pressure control were performed until delivery or pre-eclampsia onset. CPAP retitration was performed between weeks 20 and 22 of pregnancy.Mean respiratory disturbance index was 8.5+/-2.6 events/h of sleep, and initial nasal CPAP pressures were 5-6 cm H(2)O with an increase to 6-9 cm H2O after recalibration. All subjects with chronic hypertension maintained blood pressures below 140/90 with a mean diurnal blood pressure of 122+/-2.5 mmHg over 83+/-1.5 mmHg. Patient characteristics of obesity and prior pre-eclampsia were associated with pregnancies complicated by spontaneous abortion, premature delivery, or pre-eclampsia.Early application of nasal CPAP in pregnant women alleviated sleep-related breathing disturbances but was not sufficient to prevent negative pregnancy outcomes. Obesity and prior pre-eclampsia appeared to be important factors and were associated with the worst complications. However, nasal positive pressure may still be beneficial to decrease severity of outcomes, particularly if individualized to patient risk factors, more particularly hypertension at pregnancy onset.

  View details for DOI 10.1016/j.sleep.2007.04.020

  View details for PubMedID 17644420

• Bacterial flora-typing with targeted, chip-based Pyrosequencing BMC MICROBIOLOGY Sundquist, A., Bigdeli, S., Jalili, R., Druzin, M. L., Waller, S., Pullen, K. M., El-Sayed, Y. Y., Taslimi, M. M., Batzoglou, S., Ronaghi, M. 2007; 7

  Abstract

  The metagenomic analysis of microbial communities holds the potential to improve our understanding of the role of microbes in clinical conditions. Recent, dramatic improvements in DNA sequencing throughput and cost will enable such analyses on individuals. However, such advances in throughput generally come at the cost of shorter read-lengths, limiting the discriminatory power of each read. In particular, classifying the microbial content of samples by sequencing the < 1,600 bp 16S rRNA gene will be affected by such limitations.We describe a method for identifying the phylogenetic content of bacterial samples using high-throughput Pyrosequencing targeted at the 16S rRNA gene. Our analysis is adapted to the shorter read-lengths of such technology and uses a database of 16S rDNA to determine the most specific phylogenetic classification for reads, resulting in a weighted phylogenetic tree characterizing the content of the sample. We present results for six samples obtained from the human vagina during pregnancy that corroborates previous studies using conventional techniques.Next, we analyze the power of our method to classify reads at each level of the phylogeny using simulation experiments. We assess the impacts of read-length and database completeness on our method, and predict how we do as technology improves and more bacteria are sequenced. Finally, we study the utility of targeting specific 16S variable regions and show that such an approach considerably improves results for certain types of microbial samples. Using simulation, our method can be used to determine the most informative variable region.This study provides positive validation of the effectiveness of targeting 16S metagenomes using short-read sequencing technology. Our methodology allows us to infer the most specific assignment of the sequence reads within the phylogeny, and to identify the most discriminative variable region to target. The analysis of high-throughput Pyrosequencing on human flora samples will accelerate the study of the relationship between the microbial world and ourselves.

  View details for DOI 10.1186/1471-2180-7-108

  View details for Web of Science ID 000253968300001

  View details for PubMedID 18047683

  View details for PubMedCentralID PMC2244631

• Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: A Randomized controlled trial - In reply OBSTETRICS AND GYNECOLOGY Lyell, D. J., El-Sayed, Y. Y. 2007; 110 (5): 1171-1171

  View details for Web of Science ID 000250360800036

• Randomized comparison of intravenous terbutaline vs nitroglycerin for acute intrapartum fetal resuscitation 27th Annual Meeting of the Society-of-Maternal-Fetal-Medicine Pullen, K. M., Riley, E. T., Waller, S. A., Taylor, L., Caughey, A. B., Druzin, M. L., El-Sayed, Y. Y. MOSBY-ELSEVIER. 2007

  Abstract

  The purpose of this study was to compare terbutaline and nitroglycerin for acute intrapartum fetal resuscitation.Women between 32-, 42 weeks' gestation were assigned randomly to 250 microg of terbutaline or 400 microg nitroglycerin intravenously for nonreassuring fetal heart rate tracings in labor. The rate of successful acute intrapartum fetal resuscitation and the maternal hemodynamic changes were compared. Assuming a 50% failure rate in the terbutaline arm, we calculated that a total of 110 patients would be required to detect a 50% reduction in failure in the nitroglycerin group (50% to 25%), with an alpha value of .05, a beta value of .20, and a power of 80%.One hundred ten women had nonreassuring fetal heart rate tracings in labor; 57 women received terbutaline, and 53 women received nitroglycerin. Successful acute resuscitation rates were similar (terbutaline 71.9% and nitroglycerin 64.2%; P = .38). Terbutaline resulted in lower median contraction frequency per 10 minutes (2.9 [25-75 percentile, 1.7- 3.3] vs 4 [25-75 percentile, 2.5- 5]; P < .002) and reduced tachysystole (1.8% vs 18.9%; P = .003). Maternal mean arterial pressures decreased with nitroglycerin (81-76 mm Hg; P = .02), but not terbutaline (82-81 mm Hg; P = .73).Although terbutaline provided more effective tocolysis with less impact on maternal blood pressure, no difference was noted between nitroglycerin and terbutaline in successful acute intrapartum fetal resuscitation.

  View details for DOI 10.1016/j.ajog.2007.06.063

  View details for Web of Science ID 000250097300031

  View details for PubMedID 17904983

• Cesarean delivery outcomes after a prolonged second stage of labor 27th Annual Meeting of the Society-of-Maternal-Fetal-Medicine Sung, J. F., Daniels, K. I., Brodzinsky, L., El-Sayed, Y. Y., Caughey, A. B., Lyell, D. J. MOSBY-ELSEVIER. 2007

  Abstract

  We hypothesized that prolonged second stage of labor increases the incidence of unintentional hysterotomy extensions at cesarean delivery.A retrospective cohort of term pregnant women who underwent primary cesarean delivery after failed second stage of labor at Stanford University was assessed for hysterotomy extensions and other maternal and neonatal morbidities. Groups included second stage length of 1-3 hours and >4 hours. Data were analyzed with the use of chi-square and Fisher's exact tests.Of the 239 women who were studied, the second stage of labor lasted 1-3 hours in 82 patients and >4 hours in 157 patients. Prolonged second stage of labor was associated with unintentional hysterotomy extensions (40% vs 26%; P = .03), particularly to the cervix (29% vs 5%; P = .005), and with surgery that lasted >90 minutes (9% vs 1%; P = .01). The incidence of hysterotomy extensions was associated positively with the length of the second stage. Other maternal and neonatal morbidities were similar between groups.Prolonged second stage of labor is associated with an increase in unintentional hysterotomy extensions at cesarean delivery and prolonged operative time. The future risk of hysterotomy extensions merits further investigation.

  View details for DOI 10.1016/j.ajog.2007.07.005

  View details for PubMedID 17826431

• Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor - A randomized controlled trial 26th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Lyell, D. J., Pullen, K., Campbell, L., Ching, S., Druzin, M. L., Chitkara, U., Burrs, D., Caughey, A. B., El-Sayed, Y. Y. LIPPINCOTT WILLIAMS & WILKINS. 2007: 61–67

  Abstract

  To compare the efficacy and side effects of intravenous magnesium to oral nifedipine for acute tocolysis of preterm labor.A multicenter randomized trial was performed. Patients in active preterm labor who were at 24 to 33 weeks and 6 days of gestation were randomly assigned to receive magnesium sulfate or nifedipine. The primary outcome was arrest of preterm labor, defined as prevention of delivery for 48 hours with uterine quiescence.One hundred ninety-two patients were enrolled. More patients assigned to magnesium sulfate achieved the primary outcome (87% compared with 72%, P=.01). There were no differences in delivery within 48 hours (7.6% magnesium sulfate compared with 8.0% nifedipine, P=.92), gestational age at delivery (35.8 compared with 36.0 weeks, P=.61), birth before 37 and 32 weeks (57% compared with 57%, P=.97, and 11% compared with 8%, P=.39), and episodes of recurrent preterm labor. Mild and severe maternal adverse effects were significantly more frequent with magnesium sulfate. Birth weight, birth weight less than 2,500 g, and neonatal morbidities were similar between groups, but newborns in the magnesium sulfate group spent longer in the neonatal intensive care unit (8.8+/-17.7 compared with 4.2+/-8.2 days, P=.007).Patients who received magnesium sulfate achieved the primary outcome more frequently. However, delay of delivery, gestational age at delivery, and neonatal outcomes were similar between groups. Nifedipine was associated with fewer maternal adverse effects.

  View details for Web of Science ID 000247572700011

  View details for PubMedID 17601897

• Perinatal outcomes after successful and failed trials of labor after cesarean delivery. American journal of obstetrics and gynecology El-Sayed, Y. Y., Watkins, M. M., Fix, M., Druzin, M. L., Pullen, K. M., Caughey, A. B. 2007; 196 (6): 583 e1-5

  Abstract

  To compare maternal and neonatal outcomes after successful and failed trials of labor after cesarean in women at term, excluding uterine ruptures, and to examine predictors of successful and failed trials of labor.Matched maternal and neonatal data from 1993-1999 in women with singleton term pregnancies with prior cesarean undergoing trial of labor were reviewed. Women with uterine rupture were excluded. Maternal and neonatal outcomes were analyzed for successful and failed trials. Predictors of success and failure were examined.1284 women and their neonates were available for analysis. 1094 (85.2%) had a vaginal birth and 190 (14.8%) underwent repeat cesarean. Failed trials of labor were associated with higher incidence of choriamnionitis (25.8% vs. 5.5%, P<.001), postpartum hemorrhage (35.8% vs. 15.8%, P<.001), hysterectomy (1% vs. 0%, P=.022), neonatal jaundice (17.4% vs.10.2%, P=.004) and composite major neonatal morbidities (6.3% vs. 2.8%, P=.014).Failed trial of labor in women at term with prior cesarean is associated with increased maternal and neonatal morbidities.

  View details for PubMedID 17547905

• Perinatal outcomes after successful and failed trials of labor after cesarean delivery 73rd Annual Meeting of the Pacific-Coast-Obstetrical-and-Gynecological-Society El-Sayed, Y. Y., Watkins, M. M., Fix, M., Druzin, M. L., Pullen, K. M., Caughey, A. B. MOSBY-ELSEVIER. 2007: 583–85

  Abstract

  To compare maternal and neonatal outcomes after successful and failed trials of labor after cesarean in women at term, excluding uterine ruptures, and to examine predictors of successful and failed trials of labor.Matched maternal and neonatal data from 1993-1999 in women with singleton term pregnancies with prior cesarean undergoing trial of labor were reviewed. Women with uterine rupture were excluded. Maternal and neonatal outcomes were analyzed for successful and failed trials. Predictors of success and failure were examined.1284 women and their neonates were available for analysis. 1094 (85.2%) had a vaginal birth and 190 (14.8%) underwent repeat cesarean. Failed trials of labor were associated with higher incidence of choriamnionitis (25.8% vs. 5.5%, P<.001), postpartum hemorrhage (35.8% vs. 15.8%, P<.001), hysterectomy (1% vs. 0%, P=.022), neonatal jaundice (17.4% vs.10.2%, P=.004) and composite major neonatal morbidities (6.3% vs. 2.8%, P=.014).Failed trial of labor in women at term with prior cesarean is associated with increased maternal and neonatal morbidities.

  View details for DOI 10.1016/j.ajog.2007.03.013

  View details for Web of Science ID 000247137600035

• A cost-analysis of neuraxial analgesia to facilitate external cephalic version 39th Annual Meeting of the Society-for-Obstetric-Anesthesia-and-Perinatology Tan, J. M., Macario, A., El-Sayed, Y., Carvalho, B. LIPPINCOTT WILLIAMS & WILKINS. 2007: B53–B53

  View details for Web of Science ID 000246032500129

• Use of a community mobile health van to increase early access to prenatal care MATERNAL AND CHILD HEALTH JOURNAL Edgerley, L. P., El-Sayed, Y. Y., Druzin, M. L., Kiernan, M., Daniels, K. I. 2007; 11 (3): 235-239

  Abstract

  To examine whether the use of a community mobile health van (the Lucile Packard Childrens Hospital Women's Health Van) in an underserved population allows for earlier access to prenatal care and increased rate of adequate prenatal care, as compared to prenatal care initiated in community clinics.We studied 108 patients who initiated prenatal care on the van and delivered their babies at our University Hospital from September 1999 to July 2004. One hundred and twenty-seven patients who initiated prenatal care in sites other than the Women's Health Van, had the same city of residence and source of payment as the study group, and also delivered their babies at our hospital during the same time period, were selected as the comparison group. Gestational age at which prenatal care was initiated and the adequacy of prenatal care - as defined by Revised Graduated Index of Prenatal Care Utilization (RGINDEX) - were compared between cases and comparisons.Underserved women utilizing the van services for prenatal care initiated care three weeks earlier than women using other services (10.2 +/- 6.9 weeks vs. 13.2 +/- 6.9 weeks, P = 0.001). In addition, the data showed that van patients and non-van patients were equally likely to receive adequate prenatal care as defined by R-GINDEX (P = 0.125).Women who initiated prenatal care on the Women's Health Van achieved earlier access to prenatal care when compared to women initiating care at other community health clinics.

  View details for DOI 10.1007/s10995-006-0174-z

  View details for Web of Science ID 000246578900005

  View details for PubMedID 17243022

• Is external cephalic version cost-effective? 39th Annual Meeting of the Society-for-Obstetric-Anesthesia-and-Perinatology Tan, J. M., Macario, A., Carvalho, B., El-Sayed, Y. LIPPINCOTT WILLIAMS & WILKINS. 2007: B16–B16

  View details for Web of Science ID 000246032500055

• Delivery mode by race for breech presentation in the US JOURNAL OF PERINATOLOGY Lee, H. C., El-Sayed, Y. Y., Gould, J. B. 2007; 27 (3): 147-153

  Abstract

  To determine if there are differential cesarean delivery rates by race and other socio-demographic factors for women with breech infants.We calculated cesarean delivery rates for 186 727 White, African American, Hispanic and Asian women delivering breech singletons with gestational age 26 to 41 weeks born in 1999 and 2000 using data from the National Center for Health Statistics. Multivariable logistic regression was used to determine differences in mode of delivery by race, adjusting for socio-demographic and medical factors.Cesarean rates for breech were >80% in most gestational age groups. In 14 of 18 groups, Whites had higher cesarean delivery rates than African Americans. However, this finding did not persist after risk adjustment. Hispanics were more likely to deliver by cesarean delivery than African Americans and Whites.Breech singleton infants are predominantly born by cesarean delivery. Although African-American women with breech presentation have lower cesarean delivery rates than Whites, this difference is not present after adjusting for socio-demographic and medical factors. Hispanics were more likely to be delivered by cesarean delivery and this difference was amplified after risk adjustment. Asians had slightly lower cesarean rates after risk adjustment, but this varied widely according to Asian subgroup.

  View details for DOI 10.1038/sj.jp.7211668

  View details for Web of Science ID 000244420900003

  View details for PubMedID 17314983

• Cesarean delivery on maternal request: Wise use of finite resources? A view from the trenches SEMINARS IN PERINATOLOGY Druzin, M. L., El-Sayed, Y. Y. 2006; 30 (5): 305-308

  Abstract

  Cesarean section rates are rising in the United States and were at an all time high of 29 percent in 2004. Within this context, the issue of cesarean section on maternal request has been described as being part of a "perfect storm" of medical, legal and personal choice issues, and the lack of an opposing view. An increasing cesarean section rate adds an economic burden on already highly stressed medical systems. There is an incremental cost of cesarean section compared to vaginal delivery. The issue of cost must also be considered more broadly. Rising cesarean section rates are associated with a longer length of stay and a higher occupancy rate. This high occupancy rate leads to the diversion of critical care obstetric transports and has dramatically reduced patient satisfaction. These diversions, and the resultant inability to provide needed care to pregnant women, represent a profound societal cost. These critical care diversions and reduced patient satisfaction also negatively impact a health care institution's financial bottom line and competitiveness. The impact of a rising cesarean section rate on both short and long-term maternal and neonatal complications, and their associated costs, must also be taken into account. The incidence of placenta accreta is increasing in conjunction with the rising cesarean section rate. The added costs associated with this complication (MRI, Interventional Radiology, transfusion, hysterectomy, and intensive care admission) can be prohibitive. It has also been demonstrated that infants born by scheduled cesarean delivery are more likely to require advanced nursery support (with all its associated expense) than infants born to mothers attempting vaginal delivery. The practice of maternal request cesarean section, with limited good data and obvious inherent risk and expense, is increasing in the USA. Patient autonomy and a woman's right to choose her mode of delivery should be respected. However, in our opinion, based on the current evidence regarding cesarean delivery on maternal request, promotion of primary cesarean section on request as a standard of care or as a mandated part of patient counseling for delivery will result in a highly questionable use of finite resources. As of 2004, 46 million Americans did not even have basic health insurance. It is critical that we not allow ourselves to be dragged into the eye of a "perfect storm." This conference is an important step in the rational and objective analysis of this issue.

  View details for DOI 10.1053/j.semperi.2006.07.012

  View details for Web of Science ID 000241449600013

  View details for PubMedID 17011403

• Perinatal outcomes among Asian American and Pacific Islander women 26th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Rao, A. K., Daniels, K., El-Sayed, Y. Y., Moshesh, M. K., Caughey, A. B. MOSBY-ELSEVIER. 2006: 834–38

  Abstract

  The purpose of this study was to examine perinatal outcomes between Asian American and Pacific Islander subgroups.This is a retrospective study of all Asian American/Pacific Islander women who were delivered at Stanford University Medical Center from 1998 to 2003. Asian American women were subdivided into the following groups: Indian/Pakistani, Chinese, Filipino, Japanese, Korean, Pacific Islanders (individuals from Tonga, Samoa, Guam, or Polynesia), and Vietnamese. Perinatal outcomes included gestational hypertension/preeclampsia, gestational diabetes mellitus, preterm delivery, cesarean delivery, birthweight <2500 g, and birthweight >4000 g.In the study population of 3779 Asian American women, there were statistically significant differences (P < .01) between most of the outcomes that were examined. Filipina women had the highest risk of gestational hypertension/preeclampsia (adjusted odds ratio, 2.21); Indian/Pakistani women had the highest risk of preterm delivery (adjusted odds ratio, 1.67), gestational diabetes mellitus (adjusted odds ratio, 1.39), and low birthweight at term (adjusted odds ratio, 2.30); and Pacific Islander women had the highest risk of macrosomia (adjusted odds ratio, 3.67).Significant differences in perinatal outcomes exist between subgroups of the Asian American and Pacific Islander community. Future research on race/ethnicity and perinatal outcomes should examine heterogeneity among these groups before collapsing these individual subgroups into the larger group "Asian." Individuals should be counseled regarding perinatal risk according to their specific Asian subgroup.

  View details for DOI 10.1016/j.ajog.2006.06.079

  View details for Web of Science ID 000240473500031

  View details for PubMedID 16949421

• Perinatal outcomes among Asian Americans/Pacific islanders 26th Annual Meeting of the Society-for-Maternal-Fetal-Medicine Rao, A. K., Daniels, K., El-Sayed, Y. Y., Moshesh, M. K., Caughey, A. B. MOSBY-ELSEVIER. 2005: S182–S182

  View details for Web of Science ID 000233947800639

• Vascular-type disruptive defects in fetuses with homozygous alpha-thalassemia: report of two cases and review of the literature PRENATAL DIAGNOSIS Adam, M. P., Chueh, J., El-Sayed, Y. Y., Stenzel, A., Voge, H., Weaver, D. D., Hoyme, H. E. 2005; 25 (12): 1088-1096

  Abstract

  The thalassemias are an inherited group of heterogeneous anemias in which one or more of the globin chains in the hemoglobin tetramer are absent. Fetuses with homozygous alpha-thalassemia, which is particularly prevalent in people of Southeast Asian extraction, experience deficient alpha-globin chain synthesis and cannot produce hemoglobin F (the primary fetal hemoglobin after 8 weeks' gestation). Instead, they produce an anomalous hemoglobin, hemoglobin Bart's, with an unusually high affinity for oxygen, leading to profound anemia and tissue hypoxia.Here we report on two fetuses with homozygous alpha-thalassemia who displayed structural defects of a vascular disruptive type. Both fetuses demonstrated limb anomalies, including terminal transverse limb deficiencies, and one fetus was found to have a brain malformation consisting of a neuronal migrational defect. The limb anomalies and suspected brain malformation were detected on prenatal ultrasound prior to confirmation of the diagnosis of alpha-thalassemia in one case; in the other case prenatal records were not available. While microcephaly, hydrocephalus, and retarded brain growth have been rarely reported in association with homozygous alpha-thalassemia, this is the first report of a true brain malformation in an affected fetus. Limb anomalies, on the other hand, appear to be more frequent. Recently, aggressive in utero and postnatal therapies for homozygous alpha-thalassemia have been attempted with some success.Our cases and those from the medical literature suggest that couples need to be counseled about the risks of congenital anomalies of a vascular disruptive type in affected fetuses. Furthermore, data from the literature suggests that in utero therapy may not significantly decrease these risks as such anomalies may be present prior to the institution of therapy. In addition, in hydropic infants with vascular disruptive defects, especially in those of Southeast Asian origin, homozygous alpha-thalassemia should be suspected as a likely etiology.

  View details for DOI 10.1002/pd.1276

  View details for Web of Science ID 000234280900003

  View details for PubMedID 16231329

• Factors that predict prematurity and preeclampsia in pregnancies that are complicated by systemic lupus erythematosus 71st Annual Meeting of the Central-Association-of-Obstetricians-and-Gynecologists Chakravarty, E. F., Colon, I., Langen, E. S., Nix, D. A., El-Sayed, Y. Y., Genovese, M. C., Druzin, M. L. MOSBY-ELSEVIER. 2005: 1897–1904

  Abstract

  The purpose of this study was to describe the outcomes of a 10-year cohort of pregnancies in patients with systemic lupus erythematosus and to evaluate clinical and laboratory markers for adverse outcomes.We reviewed all pregnancies in patients with systemic lupus erythematosus who were seen at Stanford University from 1991 to 2001. Univariate analyses were performed to identify potential risk factors for adverse outcomes.Sixty-three pregnancies in 48 women were identified. Approximately 35% of the pregnancies occurred in women with previous renal disease and 10% in women with previous central nervous system disease. Flares occurred in 68% of the pregnancies, the majority of which were mild to moderate. Preeclampsia complicated 12 pregnancies. Factors that were associated with premature delivery included prednisone use at conception (relative risk, 1.8), the use of antihypertensive medications (relative risk, 1.8), and a severe flare during pregnancy (relative risk, 2.0). Thrombocytopenia was associated with an increased risk of preeclampsia (relative risk, 3.2).Flares, most of which were mild to moderate, occurred most of the pregnancies in our cohort of patients with systemic lupus erythematosus. Thrombocytopenia, hypertension, and prednisone use may be predictive factors for particular adverse outcomes.

  View details for DOI 10.1016/j.ajog.2005.02.063

  View details for Web of Science ID 000230037600034

  View details for PubMedID 15970846

• Randomized comparison of intravenous nitroglycerin and subcutaneous terbutaline for external cephalic version under tocolysis AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY El-Sayed, Y. Y., Pullen, K., Riley, E. T., Lyell, D., Druzin, M. L., Cohen, S. E., Chitkara, U. 2004; 191 (6): 2051-2055

  Abstract

  The purpose of this study was to compare the efficacy and safety of intravenous nitroglycerin with that of subcutaneous terbutaline as a tocolytic agent for external cephalic version at term.We performed a prospective randomized trial. Patients between 37 and 42 weeks of gestation were assigned randomly to receive either 200 microg of intravenous nitroglycerin therapy or 0.25 mg of subcutaneous terbutaline therapy for tocolysis during external cephalic version. The rate of successful external cephalic version and side effects were compared between groups.Of 59 randomly assigned patients, 30 patients received intravenous nitroglycerin, and 29 patients received subcutaneous terbutaline. The overall success rate of external cephalic version in the study was 39%. The rate of successful external cephalic version was significantly higher in the terbutaline group (55% vs 23%; P = .01). The incidence of palpitations was significantly higher in patients who received terbutaline therapy (17.2% vs 0%; P = .02), as was the mean maternal heart rate at multiple time periods.Compared with intravenous nitroglycerin, subcutaneous terbutaline was associated with a significantly higher rate of successful external cephalic version at term.

  View details for DOI 10.1016/j.ajog.2004.04.040

  View details for Web of Science ID 000225925800030

  View details for PubMedID 15592291

• Medical versus surgical management of biliary tract disease in pregnancy 56th Annual Meeting of the Southwestern-Surgical-Congress Lu, E. J., Curet, M. J., El-Sayed, Y. Y., Kirkwood, K. S. EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC. 2004: 755–59

  Abstract

  The management of symptomatic cholelithiasis during pregnancy remains controversial. We compared outcomes after medical versus surgical management of biliary tract disease in pregnant patients.We reviewed the clinical course of patients with symptomatic cholelithiasis during pregnancy from 1992 to 2002 at two university hospitals.Seventy-six women with 78 pregnancies were admitted with biliary tract disease. Of the 63 women who presented with symptomatic cholelithiasis, 10 underwent surgery while pregnant. There were no deaths, preterm deliveries, or intensive care unit admissions. Fifty-three patients were treated medically. Their clinical courses were complicated by symptomatic relapse in 20 patients (38%), by labor induction to control biliary colic (8 patients), and by premature delivery in 2 patients. Each relapse in the medically managed group accounted for an additional five days in hospital.Surgical management of symptomatic cholelithiasis in pregnancy is safe, decreases days in hospital, and reduces the rate of labor induction and preterm deliveries.

  View details for DOI 10.1016/j.amsjurg.2004.09.002

  View details for Web of Science ID 000226183600040

  View details for PubMedID 15619495

• Vaginal versus ultrasound examination of fetal occiput position during the second stage of labor AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Chou, M. R., Kreiser, D., Taslimi, M. M., Druzin, M. L., El-Sayed, Y. Y. 2004; 191 (2): 521-524

  Abstract

  The purpose of this study was to determine whether ultrasonography is more accurate than vaginal examination in the determination of fetal occiput position in the second stage of labor.Eighty-eight patients in the second stage of labor were evaluated by vaginal examination and by combined transabdominal and transperineal ultrasound examination to determine occiput position. These predictions of position were compared with the actual delivery position at vaginal delivery after spontaneous restitution or at cesarean delivery. Different examiners performed the vaginal examinations and the ultrasound examinations. Each examiner was blinded to the determination of the other examiner.Vaginal examination determined fetal occiput position correctly 71.6% of the time; ultrasound examination determined fetal occiput position correctly 92.0% of the time (P=.018).Ultrasound examination is more accurate than vaginal examination in the diagnosis of fetal occiput position in the second stage of labor.

  View details for DOI 10.1016/j.ajog.2004.01.029

  View details for Web of Science ID 000203976500020

  View details for PubMedID 15343230

• Cost-effectiveness of a trial of labor after previous cesarean delivery depends on the a priori chance of success CLINICAL OBSTETRICS AND GYNECOLOGY Macario, A., El-Sayed, Y. Y., Druzin, M. L. 2004; 47 (2): 378-385

  View details for Web of Science ID 000231530600009

  View details for PubMedID 15166861

• Neu-Laxova syndrome: Detailed prenatal diagnostic and post-mortem findings and literature review AMERICAN JOURNAL OF MEDICAL GENETICS PART A Manning, M. A., Cunniff, C. M., Colby, C. E., El-Sayed, Y. Y., Hoyme, H. E. 2004; 125A (3): 240-249

  Abstract

  Neu-Laxova syndrome (NLS) is a lethal, autosomal recessive multiple malformation syndrome with many features resulting from severe skin restriction and decreased fetal movement. It is characterized by ichthyosis, marked intrauterine growth restriction (IUGR), microcephaly, short neck, central nervous system (CNS) anomalies, limb deformities, hypoplastic lungs, edema, and abnormal facial features including severe proptosis with ectropion, hypertelorism, micrognathia, flattened nose, and malformed ears. We present two new patients with NLS with striking prenatal diagnostic findings and detailed post-mortem examinations and review the previously described cases in the literature. Data from these patients suggest that the NLS represents a heterogeneous phenotype. Prenatal ultrasound findings of marked ocular proptosis in a growth restricted, edematous fetus should prompt consideration of a diagnosis of the NLS.

  View details for DOI 10.1002/ajmg.a.20467

  View details for Web of Science ID 000189316800004

  View details for PubMedID 14994231

• Central nervous system lupus and pregnancy: 11-year experience at a single center. journal of maternal-fetal & neonatal medicine El-Sayed, Y. Y., Lu, E. J., Genovese, M. C., Lambert, R. E., Chitkara, U., Druzin, M. L. 2002; 12 (2): 99-103

  Abstract

  To describe the pregnancy outcomes in women with central nervous system (CNS) manifestations of lupus.Between 1991 and 2002, the outcome of five pregnancies in four patients with CNS lupus were retrospectively reviewed. All patients had an established history of systemic lupus erythematosus (SLE), and either a history of CNS lupus or active CNS lupus. Pregnancy outcomes assessed included term and preterm birth, intrauterine growth restriction, abnormal antepartum testing, perinatal mortality, pre-eclampsia and other maternal morbidities.Evidence of active CNS lupus symptoms developed in three of the five pregnancies. Two pregnancies were complicated by early onset pre-eclampsia, abnormal antepartum testing and extreme prematurity, with one subsequent neonatal death. The remaining three pregnancies had good neonatal outcomes, but were complicated by severe maternal post-pregnancy exacerbations, and the eventual death of one patient.CNS lupus in pregnancy represents an especially severe manifestation of SLE, and may involve great maternal and fetal risks.

  View details for PubMedID 12420839

• A longitudinal analysis of maternal serum insulin-like growth factor I (IGF-I) and total and nonphosphorylated IGF-binding protein-1 in human pregnancies complicated by intrauterine growth restriction IGFBP 2000 Meeting Bhatia, S., Faessen, G. H., Carland, G., Balise, R. L., Gargosky, S. E., Druzin, M., El-Sayed, Y., Wilson, D. M., Giudice, L. C. ENDOCRINE SOC. 2002: 1864–70

  Abstract

  In cord blood and late gestation maternal serum, IGF-I is positively correlated with birth weight, whereas IGF-binding protein-1 (IGFBP-1) is inversely correlated with birth weight. Our goal was to determine whether maternal serum or amniotic fluid concentrations of IGF-I, IGFBP-1, or nonphosphorylated IGFBP-1 (npIGFBP-1) in early gestation predict later fetal growth abnormalities. Maternal serum was collected prospectively across gestation (5-40 wk) from 749 pregnant subjects. Amniotic fluid was collected after amniocentesis during wk 15-26 from 207 subjects. We compared median serum concentrations of IGF-I, IGFBP-1, and npIGFBP-1 in 38 subjects who delivered growth-restricted infants with the control group of 236 subjects with normal weight infants for each gestational age grouping, wk 5-12, 13-23, and 24-34. In the control group median IGF-I concentrations were 14.8, 11, and 15.6 nmol/liter for wk 5-12, 13-23, and 24-34, respectively, compared with 13.7, 14.3, and 10.6 nmol/liter in the intrauterine growth restriction (IUGR) group. Median IGFBP-1 concentrations were 8.5, 30.4, and 24.4 nmol/liter, respectively, in controls, compared with 11.4, 28.6, and 25.5 nmol/liter in the IUGR group. Median npIGFBP-1 concentrations were 6.9, 22, and 17.4 nmol/liter, respectively, in controls, compared with 5.0, 32.1, and 24.2 nmol/liter in the IUGR group. In the control group the median amniotic fluid IGFBP-1 level was 13,160 nmol/liter, and the median npIGFBP-1 level was 15,970 nmol/liter; in the IUGR group these levels were 13,440 and 18,440 nmol/liter, respectively. No clinically useful differences were found between the IUGR and control groups. Our results do not support the use of maternal serum IGF-I or IGFBP-1 or amniotic fluid IGFBP-1 or npIGFBP-1 early in gestation to predict later fetal growth restriction.

  View details for PubMedID 11932331

• Fetal ear length measurement: a useful predictor of aneuploidy? ULTRASOUND IN OBSTETRICS & GYNECOLOGY Chitkara, U., Lee, L., Oehlert, J. W., Bloch, D. A., Holbrook, R. H., El-Sayed, Y. Y., Druzin, M. L. 2002; 19 (2): 131-135

  Abstract

  To determine the usefulness of short ear length (EL) measurement in the prenatal detection of fetuses with chromosomal abnormalities.Fetal EL measurements, routine biometry and complete anatomic survey for fetal abnormalities were prospectively performed by antenatal sonography.One thousand eight hundred and forty-eight patients with singleton pregnancies undergoing genetic amniocentesis in the second or third trimester.Complete data for EL, biometry and anatomic survey for major structural abnormalities and minor sonographic markers of chromosomal abnormality were available in 1311 fetuses. Of these, 48 (3.7%) had an abnormal karyotype and 1263 (96.3%) had a normal karyotype. Using an EL measurement of < or = 10th percentile for corresponding gestational age in normal fetuses as abnormal cut-off values, detection rates for chromosomal abnormalities by short EL were determined.Among the 48 abnormal karyotypes, 34 were considered significant, and 11 of these 34 (32.4%) fetuses had short EL. In 14 cases, the karyotypic abnormality was considered non-significant and fetal EL was normal in all cases. Of the 34 fetuses with significant chromosomal abnormalities, six (17.6%) on antenatal sonography had no detectable abnormal findings, other than short EL. An increased biparietal diameter (BPD)/EL ratio of > or = 4.0 was also noted in fetuses with an abnormal karyotype, but the sensitivity and predictive value of increased BPD/EL ratio alone or increased BPD/EL ratio in combination with short EL was no better than the sensitivity and predictive value of short EL alone. A combination of short EL and abnormal ultrasound, however, gave a much higher positive predictive value (46%) for significant chromosomal abnormalities.Our findings suggest that in women at high risk for fetal chromosomal abnormality, a short fetal EL measurement on prenatal ultrasound, either alone or in combination with other sonographically detectable structural abnormalities, may be a useful parameter in predicting fetal aneuploidy.

  View details for Web of Science ID 000174123500004

  View details for PubMedID 11876803

• Mask induction with sevoflurane in a parturient with severe tracheal stenosis ANESTHESIOLOGY Ratner, E. F., Cohen, S. E., El Sayed, Y., Druzin, M. 2001; 95 (2): 553-555

  View details for Web of Science ID 000170237800040

  View details for PubMedID 11506134

• Decreased amniotic fluid index in low-risk pregnancy JOURNAL OF REPRODUCTIVE MEDICINE Kreiser, D., El-Sayed, Y. Y., Sorem, K. A., Chitkara, U., Holbrook, R. H., Druzin, M. L. 2001; 46 (8): 743-746

  Abstract

  To evaluate the perinatal outcomes of pregnancies complicated by isolated decreased amniotic fluid volume (AFI) after 30 weeks' gestation (AFI < or = 5 or > 5 cm but < 2.5th percentile).We retrospectively studied 150 low-risk singleton pregnancies > 30 weeks' gestation with decreased AFI. We also compared the outcomes of 57 pregnancies with AFI < or = 5 cm to those of 93 pregnancies with AFI > 5 cm but < 2.5th percentile (borderline AFI). Pregnancy outcome was assessed with respect to antepartum, intrapartum and neonatal measures. Statistical significance (P < .05) between groups was determined by means of the Student t test and chi 2 analysis.There were no statistically significant differences between pregnancies with AFI < or = 5 cm and those with AFI > 5 cm but < 2.5th percentile with respect to labor induction for an abnormal nonstress test (7.0% vs. 7.5%, overall 7.3%), cesarean sections for fetal heart rate abnormalities (7.0% vs. 7.5%, overall 7.3%), presence of meconium (16.1% vs. 15.7%, overall 16%) and Apgar score < 7 at five minutes (0 vs. 1.1%, overall 0.66%). There were no perinatal deaths in either group. Antepartum variable decelerations were more common in pregnancies with AFI < or = 5 cm as compared to those with AFI > 5 cm but < 2.5th percentile (63.1% vs. 45.1%, P = .007; overall 53.3%).With antepartum monitoring, perinatal outcome in low-risk pregnancies with an isolated decreased AFI after 30 weeks' gestation (< or = 5 or > 5 cm but < 2.5th percentile) appears to be good.

  View details for Web of Science ID 000170694100009

  View details for PubMedID 11547649

• Cost-effectiveness of a trial of labor after previous cesarean OBSTETRICS AND GYNECOLOGY Chung, A., Macario, A., El-Sayed, Y. Y., Riley, E. T., Duncan, B., Druzin, M. L. 2001; 97 (6): 932-941

  Abstract

  To determine the cost-effective method of delivery, from society's perspective, in patients who have had a previous cesarean.We completed an incremental cost-effectiveness analysis of a trial of labor relative to cesarean using a computerized model for a hypothetical 30-year old parturient. The model incorporated data from peer-reviewed studies, actual hospital costs, and utilities to quantify health-related quality of life. A threshold of $50,000 per quality-adjusted life-years was used to define cost-effective.The model was most sensitive to the probability of successful vaginal delivery. If the probability of successful vaginal birth after cesarean (VBAC) was less than 0.65, elective repeat cesarean was both less costly and more effective than a trial of labor. Between 0.65 and 0.74, elective repeat cesarean was cost-effective (the cost-effectiveness ratio was less than $50,000 per quality-adjusted life-years), because, although it cost more than VBAC, it was offset by improved outcomes. Between 0.74 and 0.76, trial of labor was cost-effective. If the probability of successful vaginal delivery exceeded 0.76, trial of labor became less costly and more effective. Costs associated with a moderately morbid neonatal outcome, as well as the probabilities of infant morbidity occurring, heavily impacted our results.The cost-effectiveness of VBAC depends on the likelihood of successful trial of labor. Our modeling suggests that a trial of labor is cost-effective if the probability of successful vaginal delivery is greater than 0.74. Improved algorithms are needed to more precisely estimate the likelihood that a patient with a previous cesarean will have a successful vaginal delivery.

  View details for Web of Science ID 000169206300013

  View details for PubMedID 11384699

• New therapies for the pregnant patient with diabetes. Diabetes technology & therapeutics El-Sayed, Y. Y., Lyell, D. J. 2001; 3 (4): 635-640

  Abstract

  Gestational diabetes complicates 3-5% of pregnancies. Of diabetes seen during pregnancy, 10% is pregestational and the remaining 90% represents gestational diabetes. (1,2) Pregnancy in women with pregestational diabetes is especially high risk. Spontaneous abortion, preterm labor, congenital malformations, preeclampsia, macrosomia, birth injury, and cesarean section are all increased in these pregnancies. Deterioration of maternal health during pregnancy, especially in the setting of diabetes-induced end-organ disease, is a real concern. Vigilant surveillance and management of associated disorders such as retinopathy, nephropathy, and chronic hypertension are required. During the preinsulin era, maternal and perinatal mortality in pregnancies complicated by pregestational diabetes was approximately 50%. (1,2) Although modern obstetrical management and the appropriate use of insulin have dramatically improved maternal-fetal outcomes, pregnant patient with diabetes remains at increased risk for complications. There is no doubt that optimizing maternal glucose control is a key element in avoiding established perinatal risks. The most effective means to accomplish this control are topics of active research. Further, hormonal changes during pregnancy can make glycemic control difficult even for the most compliant and educated patient. This paper discusses several new approaches, either currently in practice or under consideration, to pregnancies complicated by diabetes, including oral hypoglycemic agents, lispro, the insulin pump, and transplantation.

  View details for PubMedID 11911177

• Is a trial of labor in a patient who has had a previous cesarean delivery cost-effective? Chung, A. J., Macario, A., El-Sayed, Y. Y., Riley, E. T., Druzin, M. L. LIPPINCOTT WILLIAMS & WILKINS. 2000: U212–U212

  View details for Web of Science ID 000089136800986

• Ultrasonographic ear length measurement in normal second-and third-trimester fetuses AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Chitkara, U., Lee, L., El-Sayed, Y. Y., Holbrook, R. H., Bloch, D. K., Oehlert, J. W., Druzin, M. L. 2000; 183 (1): 230-234

  Abstract

  We sought to develop a nomogram for fetal ear length measurements from a large population of healthy second- and third-trimester fetuses and to investigate the correlation of fetal ear length with other standard fetal biometry measurements, as follows: biparietal diameter, head circumference, abdominal circumference, femur length, and humerus length.Ear length measurement was obtained prospectively in 4240 singleton fetuses between 15 and 40 weeks' gestational age. Either complete data for normal karyotype on amniocentesis or normal infant examination at birth or both were available in 2583 cases. These constituted the final study population.A nomogram was developed by linearly regressing ear length on gestational age (Ear length [in millimeters] = 1.076 x Gestational age [in weeks] - 7. 308). There was a high correlation between ear length and gestational age (r = 0.96; P =.0001).The results of this study provide normative data on growth of fetal ear length from 15 to 40 weeks' gestation. Good correlation was also observed between ear length and other fetal biometric measurements (biparietal diameter, head circumference, abdominal circumference, femur length, and humerus length).

  View details for Web of Science ID 000088565500039

  View details for PubMedID 10920337

• Is a trial of labor in a patient who has had a previous cesarean delivery cost-effective? Chung, A., Macario, A., El-Sayed, Y., Riley, E. T., Duncan, B., Sheinberg, D. LIPPINCOTT WILLIAMS & WILKINS. 2000: U11–U11

  View details for Web of Science ID 000086274300035

• Surgical training in selective pelvic arterial ligation or use of embolization only - Reply AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Chitkara, U., Hansch, E., El-Sayed, Y. 2000; 182 (1): 252-252

  View details for Web of Science ID 000084987100044

• A multicenter, placebo-controlled pilot study of intravenous immune globulin treatment of antiphospholipid syndrome during pregnancy AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Branch, D. W., Peaceman, A. M., Druzin, M., Silver, R. K., El-Sayed, Y., SILVER, R. M., Esplin, M. S., Spinnato, J., Harger, J. 2000; 182 (1): 122-127

  Abstract

  Treatment with heparin and low-dose aspirin improves fetal survival among women with antiphospholipid syndrome. Despite treatment, however, these pregnancies are frequently complicated by preeclampsia, fetal growth restriction, and placental insufficiency, often with the result of preterm birth. Small case series suggest that intravenous immune globulin may reduce the rates of these obstetric complications, but the efficacy of this treatment remains unproven. This pilot study was undertaken to determine the feasibility of a multicenter trial of intravenous immune globulin and to assess the impact on obstetric and neonatal outcomes among women with antiphospholipid syndrome of the addition of intravenous immune globulin to a heparin and low-dose aspirin regimen.This multicenter, randomized, double-blind pilot study compared treatment with heparin and low-dose aspirin plus intravenous immune globulin with heparin and low-dose aspirin plus placebo in a group of women who met strict criteria for antiphospholipid syndrome. All patients had lupus anticoagulant, medium to high levels of immunoglobulin G anticardiolipin antibodies, or both. Patients with a single live intrauterine fetus at

  View details for Web of Science ID 000084987100019

  View details for PubMedID 10649166

• Congenital diaphragmatic hernia: the perinatalogist's perspective. Pediatrics in review Halamek, L. P., El-Sayed, Y. Y. 1999; 20 (10): e67-70

  View details for PubMedID 10512894

• Pelvic arterial embolization for control of obstetric hemorrhage: A five-year experience 66th Annual Meeting of the Central-Association-of-Obstetricians-and-Gynecologists Hansch, E., Chitkara, U., McAlpine, J., El-Sayed, Y., Dake, M. D., Razavi, M. K. MOSBY-ELSEVIER. 1999: 1454–60

  Abstract

  Obstetric hemorrhage is a significant cause of maternal morbidity and death. Postpartum hemorrhage that cannot be controlled by local measures has traditionally been managed by bilateral uterine artery or hypogastric artery ligation. These techniques have a high failure rate, often resulting in hysterectomy. In contrast, endovascular embolization techniques have a success rate of >90%. An additional benefit of the latter procedure is that fertility is maintained. We report our experience at Stanford University Medical Center in which this technique was used in 6 cases within the past 5 years.Six women between the ages of 18 and 41 years underwent placement of arterial catheters for emergency (n = 3) or prophylactic (n = 3) control of postpartum bleeding. Specific diagnoses included cervical pregnancy (n = 1), uterine atony (n = 3), and placenta previa and accreta (n = 2).Control of severe or anticipated postpartum hemorrhage was obtained with transcatheter embolization in 4 patients. A fifth patient had balloon occlusion of the uterine artery performed prophylactically, but embolization was not necessary. In a sixth case, bleeding could not be controlled in time, and hysterectomy was performed. The only complication observed with this technique was postpartum fever in 1 patient, which was treated with antibiotics and resolved within 7 days.Uterine artery embolization is a superior first-line alternative to surgery for control of obstetric hemorrhage. Use of transcatheter occlusion balloons before embolization allows timely control of bleeding and permits complete embolization of the uterine arteries and hemostasis. Given the improved ultrasonography techniques, diagnosis of some potential high-risk conditions for postpartum hemorrhage, such as placenta previa or accreta, can be made prenatally. The patient can then be prepared with prophylactic placement of arterial catheters, and rapid occlusion of these vessels can be achieved if necessary.

  View details for Web of Science ID 000081088200038

  View details for PubMedID 10368488

• Randomized comparison of intravenous nitroglycerin and magnesium sulfate for treatment of preterm labor OBSTETRICS AND GYNECOLOGY El-Sayed, Y. Y., Riley, E. T., Holbrook, R. H., Cohen, S. E., Chitkara, U., Druzin, M. L. 1999; 93 (1): 79-83

  Abstract

  To compare the safety and efficacy of high-dose intravenous (IV) nitroglycerin with those of IV magnesium sulfate for acute tocolysis of preterm labor.Thirty-one women with preterm labor before 35 weeks' gestation were assigned randomly to IV magnesium sulfate or IV nitroglycerin for tocolysis. Preterm labor was defined as the occurrence of at least two contractions in 10 minutes, with cervical change or ruptured membranes. Acute tocolysis was defined as tocolysis for up to 48 hours. Magnesium sulfate was administered as a 4-g bolus, then at a rate of 2-4 g/h. Nitroglycerin was administered as a 100-microg bolus, then at a rate of 1- to 10-microg/kg/min. The primary outcome measure was achievement of at least 12 hours of successful tocolysis.Thirty patients were available for analysis. There were no significant differences in gestational age, cervical dilation, or incidence of ruptured membranes between groups at the initiation of tocolysis. Successful tocolysis was achieved in six of 16 patients receiving nitroglycerin, compared with 11 of 14 receiving magnesium sulfate (37.5 versus 78.6%, P = .033). Tocolytic failures (nitroglycerin versus magnesium sulfate) were due to persistent contractions with cervical change or rupture of previously intact membranes (five of 16 versus two of 14), persistent hypotension (four of 16 versus none of 14), and other severe side effects (one of 16 versus one of 14). Maternal hemodynamic alterations were more pronounced in patients who received nitroglycerin, and 25% of patients assigned to nitroglycerin treatment had hypotension requiring discontinuation of therapy.Tocolytic failures were more common with nitroglycerin than with magnesium sulfate. The hemodynamic alterations noted in patients receiving nitroglycerin, including a 25% incidence of persistent hypotension, might limit the usefulness of IV nitroglycerin for the acute tocolysis of preterm labor.

  View details for Web of Science ID 000077885200017

  View details for PubMedID 9916961

• Diltiazem for maintenance tocolysis of preterm labor: comparison to nifedipine in a randomized trial. The Journal of maternal-fetal medicine El-Sayed, Y. Y., Holbrook, R. H., Gibson, R., Chitkara, U., Druzin, M. L., Baba, D. 1998; 7 (5): 217-221

  Abstract

  The objective of this study was to compare the safety and efficacy of maintenance tocolysis with oral diltiazem to oral nifedipine in achieving 37 weeks gestation. After successful intravenous tocolysis with magnesium sulfate, 69 women with preterm labor at <35 weeks gestation were randomly assigned to nifedipine (20 mg orally every 4-6 hr), or diltiazem (30-60 mg orally every 4-6 hr). The primary outcome was the percentage of patients achieving 37 weeks gestation. Maternal cardiovascular alterations and neonatal outcomes were also assessed. Sixty-nine patients were available for final analysis. Less patients on diltiazem as compared to nifedipine achieved 37 weeks (15.1% vs. 41.7%, P = 0.019). Gestational age at delivery was also less for patients receiving diltiazem (35.5 +/- 3.5 weeks vs. 33.4 +/- 3.9 weeks, P = 0.022). There were fewer days gained in utero from randomization to delivery with diltiazem as compared to nifedipine; however, this difference was not statistically significant (22.4 +/- 16.3 days vs. 31.2 +/- 24.4 days, P = 0.084). Maternal blood pressure and pulse during tocolysis did not differ significantly between groups. Despite the theoretical advantages of diltiazem tocolysis, maintenance tocolysis with diltiazem offered no benefit over nifedipine in achieving 37 weeks gestation. The cardiovascular alterations with either drug in normotensive, pregnant patients appear minimal.

  View details for PubMedID 9775988

• Obstetric and gynecologic care of women with epilepsy EPILEPSIA El-Sayed, Y. Y. 1998; 39: S17-S25

  Abstract

  Optimal gynecologic and obstetric care for women with epilepsy requires a multidisciplinary approach throughout the various life stages. Epilepsy has important effects on puberty, contraceptive efficacy, pregnancy and fetal development, and menopause. This article discusses these effects and makes recommendations for gynecologic and obstetric care of patients with epilepsy, with particular focus on pregnancy. Despite very real risks to both the developing fetus and the mother, the majority of women with epilepsy--with appropriate pregnancy planning and management--have good pregnancy outcomes.

  View details for Web of Science ID 000078030000004

  View details for PubMedID 9915616

• INTRATHECAL SUFENTANIL FOR LABOR ANALGESIA - SENSORY CHANGES, SIDE-EFFECTS, AND FETAL HEART-RATE CHANGES ANESTHESIA AND ANALGESIA Cohen, S. E., CHERRY, C. M., Holbrook, R. H., ELSAYED, Y. Y., Gibson, R. N., Jaffe, R. A. 1993; 77 (6): 1155-1160

  Abstract

  This study was designed to evaluate intrathecal (IT) sufentanil for labor analgesia with respect to sensory changes, side effects, and fetal heart rate (FHR) changes. In Phase I of the study, data regarding duration of analgesia and hemodynamic changes were obtained retrospectively from the labor and anesthetic records of 90 patients who had received IT sufentanil, 10 micrograms in 1 mL of saline, during active labor. In Phase II, an additional 18 parturients who received similar treatment were studied prospectively to document sensory, motor, and hemodynamic changes, as well as the incidence of side effects. In Phase I, analgesia occurred rapidly and lasted 124 +/- 68 min (SD); 19% of patients required no further analgesia before delivery. In Phase II, median time to onset of analgesia was 3 min (range 1-6 min) and mean duration of analgesia was 96 +/- 36 min. Decreased sensation to pinprick and cold occurred within 6 min extending from T4 to L4 (upper and lower median levels) in the majority of patients. All subjects requested additional analgesia within approximately 30 min of recession of sensory changes. Motor strength remained normal throughout. Hypotension (systolic blood pressure [BP] < or = 90 mm Hg or > 20% decrease in systolic BP) occurred in 14% and 11% of patients in Phase I and II, respectively. Perineal itching preceded analgesia in 95% of patients and all subjects experienced mild sedation. FHR changes occurred in 15% of cases but were not associated with adverse neonatal outcome.(ABSTRACT TRUNCATED AT 250 WORDS)

  View details for Web of Science ID A1993MK04800013

  View details for PubMedID 8250307