Publications by authors named "Uma M Reddy"

233 Publications

Outcomes in Twins Compared With Singletons Subsequent to Preterm Prelabor Rupture of Membranes.

Obstet Gynecol 2021 Oct 7. Epub 2021 Oct 7.

Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas, Northwestern University, Chicago, Illinois, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, Brown University, Providence, Rhode Island, and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To compare maternal and neonatal outcomes after preterm prelabor rupture of membranes (PROM) from 23 to 34 weeks of gestation in twin compared with singleton gestations.

Methods: We conducted a secondary analysis of an obstetric cohort of 115,502 individuals and their singleton or twin neonates born in 25 hospitals nationwide (2008-2011). Those with preterm PROM from 23 0/7 through 33 6/7 weeks of gestation were included; neonates with major fetal anomalies were excluded. The coprimary outcomes for this analysis were composite maternal morbidity (chorioamnionitis, blood transfusion, postpartum endometritis, wound infection, sepsis, venous thromboembolism, intensive care unit admission, or death) and composite major neonatal morbidity (persistent pulmonary hypertension, intraventricular hemorrhage grade III or IV, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage II or III, bronchopulmonary dysplasia, stillbirth subsequent to admission, or neonatal death before discharge). Logistic regression was used to estimate unadjusted and adjusted odds ratios (ORs) with 95% CIs for twin compared with singleton gestations.

Results: Of 1,531 (1.3%) individuals who met eligibility criteria for this analysis, 218 (14.2%) had twin gestations. The median gestational age at preterm PROM was similar between those with twins and singletons (31.2 weeks [interquartile range 27.4-32.9] vs 30.6 weeks [interquartile range 26.9-32.7], P=.23); however, those with twin gestations had a shorter median latency period (2.0 days [interquartile range 1.0-5.0] vs 3.0 days [interquartile range 2.0-8.0], P<.001). After adjustment for potential confounders, odds of experiencing composite maternal morbidity (17.9% vs 19.3%, adjusted OR 0.97, 95% CI 0.66-1.42) or composite neonatal morbidity (20.4% vs 20.5%, OR 0.97, 95% CI 0.72-1.31) did not differ between groups.

Conclusion: In a large, diverse cohort, the likelihood of composite maternal or neonatal morbidity per fetus after preterm PROM was similar for twin and singleton gestations.
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http://dx.doi.org/10.1097/AOG.0000000000004561DOI Listing
October 2021

Marijuana use, fetal growth, and uterine artery Dopplers.

J Matern Fetal Neonatal Med 2021 Sep 1:1-8. Epub 2021 Sep 1.

Department of Obstetrics & Gynecology, University of Utah Health, Salt Lake City, UT, USA.

Objective: Marijuana (MJ) use is associated with adverse effects on fetal growth. We aimed to investigate the timing of suboptimal fetal growth onset in MJ-exposed pregnancies. In addition, we aimed to explore the relationship between MJ-exposure and both abnormal uterine artery (UtA) Doppler parameters and small for gestational age (SGA).

Study Design: This was a secondary analysis of a prospective multicenter cohort that enrolled nulliparous individuals delivering non-anomalous fetuses beyond 20 weeks' gestation. Marijuana exposure was ascertained by self-report or clinical urine toxicology testing. Ultrasound estimated fetal weights (EFWs) were assessed in participants at both 16w0d-21w6d and 22w0d-29w6d. EFWs and birth weight (BW) were converted to weight percentiles (wPCT). EFW and BW wPCTs were calculated using population-based standards. Additionally, a customized standard designed to be applicable to both EFWs and BWs within the same model was also used to allow for EFW to BW percentile trajectories. The primary outcome, longitudinal wPCT, was compared between individuals with and without MJ use in a linear mixed-effects regression model adjusting for tobacco. For modeling, wPCT was smoothed across gestational age; MJ was estimated as an intercept and linear difference in the slope of gestational age. UtA Doppler notching, resistance index (RI), and pulsatility index (PI) at 16w0d-21w6d were compared using -test and . SGA at delivery was also compared.

Results: Nine thousand one hundred and sixty-three individuals met inclusion criteria; 136 (1.5%) used MJ during pregnancy. Individuals who used MJ were more likely to be younger, identify as non-Hispanic Black, and have had less education. Fetuses exposed to MJ had lower wPCT beginning at 28 weeks using population-based and customized standards, when compared to those without exposure. UtA notching, PI, and RI were similar between groups. SGA was more frequent in neonates exposed to MJ using both population-based (22 vs. 9%, <.001) and customized (25 vs. 14%, <.001) curves.

Conclusions: MJ-exposed fetuses were estimated to be smaller than unexposed fetuses starting at 28 weeks' gestation across both growth standards without a difference in UtA Doppler parameters.
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http://dx.doi.org/10.1080/14767058.2021.1960973DOI Listing
September 2021

Intrapartum Fetal Electrocardiogram in Small- and Large-for-Gestational Age Fetuses.

Am J Perinatol 2021 Aug 31. Epub 2021 Aug 31.

Departments of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.

Objective:  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.

Study Design:  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.

Results:  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.

Conclusion:  The frequency of intrapartum fetal ECG tracings with ST-events is similar among SGA, AGA, and LGA fetuses.

Key Points: · 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..
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http://dx.doi.org/10.1055/s-0041-1735285DOI Listing
August 2021

Society for Maternal-Fetal Medicine Consult Series #58: Use of antenatal corticosteroids for individuals at risk for late preterm delivery: Replaces SMFM Statement #4, Implementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery, August 2016.

Am J Obstet Gynecol 2021 Aug 5. Epub 2021 Aug 5.

The administration of antenatal corticosteroids has been widely adopted as the standard of care in the management of pregnancies at risk for preterm delivery before 37 weeks of gestation, with the primary goal of reducing neonatal morbidity. However, the long-term risks associated with antenatal corticosteroid use remain uncertain. The purpose of this Consult is to review the current literature on the benefits and risks of antenatal corticosteroid use in the late preterm period and to provide recommendations based on the available evidence. The recommendations by the Society for Maternal-Fetal Medicine are as follows: (1) we recommend offering a single course of antenatal corticosteroids (2 doses of 12 mg of intramuscular betamethasone 24 hours apart) to patients who meet the inclusion criteria of the Antenatal Late Preterm Steroids trial, ie, those with a singleton pregnancy between 34 0/7 and 36 6/7 weeks of gestation who are at high risk of preterm birth within the next 7 days and before 37 weeks of gestation (GRADE 1A); (2) we suggest consideration for the use of antenatal corticosteroids in select populations not included in the original Antenatal Late Preterm Steroids trial, such as patients with multiple gestations reduced to a singleton gestation on or after 14 0/7 weeks of gestation, patients with fetal anomalies, or those who are expected to deliver in <12 hours (GRADE 2C); (3) we recommend against the use of antenatal corticosteroids for fetal lung maturity in pregnant patients with a low likelihood of delivery before 37 weeks of gestation (GRADE 1B); (4) we recommend against the use of late preterm corticosteroids in pregnant patients with pregestational diabetes mellitus, given the risk of worsening neonatal hypoglycemia (GRADE 1C); (5) we recommend that patients at risk for late preterm delivery be thoroughly counseled regarding the potential risks and benefits of antenatal corticosteroid administration and be advised that the long-term risks remain uncertain (GRADE 1C).
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http://dx.doi.org/10.1016/j.ajog.2021.07.023DOI Listing
August 2021

Maternal and Neonatal Outcomes in Nulliparous Participants Undergoing Labor Induction by Cervical Ripening Method.

Am J Perinatol 2021 Aug 5. Epub 2021 Aug 5.

Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.

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 ≥3.5 cm. 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 = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 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..
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http://dx.doi.org/10.1055/s-0041-1732379DOI Listing
August 2021

Intrapartum Resuscitation Interventions for Category II Fetal Heart Rate Tracings and Improvement to Category I.

Obstet Gynecol 2021 09;138(3):409-416

Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD; the Departments of Obstetrics and Gynecology, the University of Texas Medical Branch at Galveston, Galveston, Texas, the University of Utah Health Sciences Center, Salt Lake City, Utah, the University of Texas McGovern Medical School at UT Health, Houston, Texas, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, the University of Alabama at Birmingham, Birmingham, Alabama, Columbia University, New York, New York, Northwestern University, Chicago, Illinois, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Brown University, Providence, Rhode Island, Stanford University, Stanford, California, Wayne State University, Detroit, Michigan, and the University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.

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.
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http://dx.doi.org/10.1097/AOG.0000000000004508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506980PMC
September 2021

A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection.

N Engl J Med 2021 07;385(5):436-444

From the Department of Obstetrics and Gynecology, Brown University, Providence, RI (B.L.H., D.J.R., D.A.); George Washington University Biostatistics Center, Washington, DC (R.G.C., L.M.F.); the University of Texas Medical Branch, Galveston (G.R.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.); Northwestern University, Chicago (M.J.D., G.M.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); Columbia University, New York (C.G.-B.); the University of Utah Health Sciences Center, Salt Lake City (M.W.V.); the University of North Carolina at Chapel Hill, Chapel Hill (W.H.G.), and Duke University, Durham (G.K.S.) - both in North Carolina; the Department of Pediatrics (R.P.), University of Alabama at Birmingham (A.T.N.T.), Birmingham; Ohio State University, Columbus (M.M.C.), the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Case Western Reserve University, Cleveland (E.K.C.); Stanford University, Stanford, CA (Y.Y.E.-S.); the University of Pennsylvania, Philadelphia (S.P.), and the University of Pittsburgh, Pittsburgh (H.N.S.); Madigan Army Medical Center, Joint Base Lewis-McChord, WA (P.G.N.); and Washington University, St. Louis (G.A.M.).

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.).
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http://dx.doi.org/10.1056/NEJMoa1913569DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8363945PMC
July 2021

Trajectories of antenatal depression and adverse pregnancy outcomes.

Am J Obstet Gynecol 2021 Jul 17. Epub 2021 Jul 17.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL.

Background: Antenatal depression affects approximately 1 of 7 pregnancies, with an increasing prevalence across gestation. Data regarding the associations between antenatal depression and adverse pregnancy outcomes yielded conflicting results. However, previous studies evaluated the cross-sectional prevalence of depression at various time points and not the depressive symptom trajectory across gestation.

Objective: This study aimed to identify whether the trajectory of antenatal depressive symptoms is associated with different risks of adverse pregnancy outcomes.

Study Design: This was a secondary analysis of a large multisite prospective cohort of nulliparous women across the United States. The Edinburgh Postpartum Depression Scale was administered at 2 study visits: between 6 and 14 weeks' gestation and between 22 and 30 weeks' gestation. The Edinburgh Postpartum Depression Scale score trajectories were categorized as improved, stable, or worsened based on whether the scores changed by at least 1 standard deviation between the 2 visits. The frequencies of adverse pregnancy outcomes (hypertensive disorders of pregnancy, abruption, cesarean delivery, preterm birth [ie, <37 weeks' gestation], small for gestational age neonates, neonatal intensive care unit admission, and maternal readmission) were compared with depression trajectories across gestation in bivariable and multivariable analyses. Secondary analyses evaluated the frequencies of spontaneous and medically indicated preterm births and frequencies of spontaneous and medically indicated preterm births before 35, 32, and 28 weeks' gestation.

Results: Of the 8784 women who completed the 2 antenatal Edinburgh Postpartum Depression Scale screens, 1141 (13.0%) had improved, 6663 (75.9%) had stable, and 980 (11.2%) had worsened depressive symptom trajectories across gestation. Compared with women with improved or stable depressive symptoms, those with worsened symptoms were more likely to experience preterm birth (8.3% vs 7.4% vs 9.9%, respectively; P=.018). After controlling for potential confounders, worsened depressive symptoms remained associated with more frequent preterm birth (adjusted odds ratio, 1.68; 95% confidence interval, 1.10-2.57).

Conclusion: Women with depression symptoms that worsen as pregnancy progresses have increased odds of preterm birth. Future research is warranted to optimize and implement effective prevention, screening, and treatment protocols for antenatal depressive symptoms as a strategy to prevent preterm birth.
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http://dx.doi.org/10.1016/j.ajog.2021.07.007DOI Listing
July 2021

Severe maternal morbidity and mortality during delivery hospitalization of class I, II, III, and super obese women.

Am J Obstet Gynecol MFM 2021 09 19;3(5):100420. Epub 2021 Jun 19.

Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, CT (Drs Ackerman, Illuzzi, Reddy, Xu, and Lipkind).

Background: Previous studies show that obesity predisposes patients to higher risks of adverse pregnancy outcomes. Data on the relationship between increasing degrees of obesity and risks of severe maternal morbidity, including mortality, are limited.

Objective: We examined the association of increasing classes of obesity, especially super obesity, with the risk of severe maternal morbidity and mortality at the time of delivery hospitalization.

Study Design: Using New York City linked birth certificates and hospital discharge data, we conducted a retrospective cohort study. This study identified delivery hospitalizations for singleton, live births in 2008-2012. Women were classified as having obesity (class I, II, III, or super obesity), as opposed to normal weight or overweight, based on prepregnancy body mass index. Cases of severe maternal morbidity were identified based on International Classification of Diseases, Ninth Revision diagnosis and procedure codes according to Centers for Disease Control and Prevention criteria. Multivariable logistic regression was used to evaluate the association between obesity classes and severe maternal morbidity, adjusting for maternal sociodemographic characteristics.

Results: During 2008-2012, there were 570,997 live singleton births with available information on prepregnancy body mass index that met all inclusion criteria. After adjusting for maternal characteristics, women with class II (adjusted odds ratio, 1.14; 95% confidence interval, 1.05-1.23), class III (adjusted odds ratio, 1.34; 95% confidence interval, 1.21-1.49), and super obesity (adjusted odds ratio, 1.99; 95% confidence interval, 1.57-2.54) were all significantly more likely to have severe maternal morbidity than normal and overweight women. Super obesity was associated with specific severe maternal morbidity indicators, including renal failure, air and thrombotic embolism, blood transfusion, heart failure, and the need for mechanical ventilation.

Conclusion: There is a significant dose-response relationship between increasing obesity class and the risk of severe maternal morbidity at delivery hospitalization. The risks of severe maternal morbidity are highest for women with super obesity. Given that this is a modifiable risk factor, women with prepregnancy obesity should be counseled on the specific risks associated with pregnancy before conception to optimize their pregnancy outcomes.
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http://dx.doi.org/10.1016/j.ajogmf.2021.100420DOI Listing
September 2021

Evaluation of Hypoglycemia in Neonates of Women at Risk for Late Preterm Delivery: An Antenatal Late Preterm Steroids Trial Cohort Study.

Am J Perinatol 2021 May 27. Epub 2021 May 27.

Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.

Objective:  In the antenatal late preterm steroids (ALPS) trial betamethasone significantly decreased short-term neonatal respiratory morbidity but increased the risk of neonatal hypoglycemia, diagnosed only categorically (<40 mg/dL). We sought to better characterize the nature, duration, and treatment for hypoglycemia.

Study Design:  Secondary analysis of infants from ALPS, a multicenter trial randomizing women at risk for late preterm delivery to betamethasone or placebo. This study was a reabstraction of all available charts from the parent trial, all of which were requested. Unreviewed charts included those lost to follow-up or from sites not participating in the reabstraction. Duration of hypoglycemia (<40 mg/dL), lowest value and treatment, if any, were assessed by group. Measures of association and regression models were used where appropriate.

Results:  Of 2,831 randomized, 2,609 (92.2%) were included. There were 387 (29.3%) and 223 (17.3%) with hypoglycemia in the betamethasone and placebo groups, respectively (relative risk [RR]: 1.69, 95% confidence interval [CI]: 1.46-1.96). Hypoglycemia generally occurred in the first 24 hours in both groups: 374/385 (97.1%) in the betamethasone group and 214/222 (96.4%) in the placebo group ( = 0.63). Of 387 neonates with hypoglycemia in the betamethasone group, 132 (34.1%) received treatment, while 73/223 (32.7%) received treatment in placebo group ( = 0.73). The lowest recorded blood sugar was similar between groups. Most hypoglycemia resolved by 24 hours in both (93.0 vs. 89.3% in the betamethasone and placebo groups, respectively,  = 0.18). Among infants with hypoglycemia in the first 24 hours, the time to resolution was shorter in the betamethasone group (2.80 [interquartile range: 2.03-7.03) vs. 3.74 (interquartile range: 2.15-15.08) hours;  = 0.002]. Persistence for >72 hours was rare and similar in both groups, nine (2.4%, betamethasone) and four (1.9%, placebo,  = 0.18).

Conclusion:  In this cohort, hypoglycemia was transient and most received no treatment, with a quicker resolution in the betamethasone group. Prolonged hypoglycemia was uncommon irrespective of steroid exposure.

Key Points: · Hypoglycemia was transient and approximately two-thirds received no treatment.. · Neonates in the ALPS trial who received betamethasone had a shorter time to resolution than those with hypoglycemia in the placebo group.. · Prolonged hypoglycemia occurred in approximately 2 out of 100 late preterm newborns, irrespective of antenatal steroid exposure..
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http://dx.doi.org/10.1055/s-0041-1729561DOI Listing
May 2021

Factors associated with appropriate treatment of acute-onset severe obstetrical hypertension.

Am J Obstet Gynecol 2021 09 20;225(3):329.e1-329.e10. Epub 2021 May 20.

Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, CT.

Background: The American College of Obstetricians and Gynecologists recommends that pregnant patients receive expeditious treatment with first-line antihypertensive agents within 1 hour of confirmed severe hypertension to reduce the risk for maternal stroke. However, it is unknown how often this guideline is followed and what factors influence a patient's likelihood of receiving guideline-concordant care.

Objective: We aimed to identify factors associated with receiving guideline-concordant treatment for an obstetrical hypertensive emergency.

Study Design: We present a case-control study of all pregnant and postpartum patients who had persistent severe hypertension (≥2 systolic blood pressures ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg, or both within 1 hour of each other) during their delivery hospitalization at a tertiary hospital from October 1, 2013, to August 31, 2020. Data were extracted from the hospital electronic medical records using standard definitions and billing and diagnosis codes. We defined receipt of the recommended treatment as administration of a first-line antihypertensive agent (intravenous labetalol, intravenous hydralazine, or immediate-release oral nifedipine) within 60 minutes of the first or second severe-range blood pressure measurement during their delivery hospitalization. Delayed treatment was defined as the administration of a first-line agent >60 minutes after the second elevated blood pressure measurement. Patients were considered untreated if a first-line agent was never administered. Maternal sociodemographic, clinical and pregnancy factors, and time and day of the week of the hypertensive emergency were compared among patients who received the recommended treatment, those who received delayed treatment, and those who were untreated. Bivariate analyses were performed, and multinomial and multivariable logistic regression models were used to adjust for potential confounders.

Results: Of the 39,918 deliveries in the cohort, 1987 (5.0%) were complicated by severe, persistent obstetrical hypertension. Of these patients, 532 (26.8%) received the recommended treatment, 356 (17.9%) received delayed treatment, and 1099 (55.3%) did not receive any first-line antihypertensive therapy. The multinomial regression models that were used to compare these 3 groups indicated that patients who received the recommended treatment were more likely to be Black (adjusted odds ratio, 1.85; 95% confidence interval, 1.36-2.51), Hispanic (adjusted odds ratio, 1.77; 95% confidence interval, 1.28-2.52), or pregnant and at <37 weeks of gestation (adjusted odds ratio, 6.65; 95% confidence interval, 5.08-8.72). Treatment was less likely if the severe obstetrical hypertension emergency occurred overnight (7:00 PM to 6:59 AM) (adjusted odds ratio, 0.79; 95% confidence interval, 0.64-0.97) or during the postpartum period (adjusted odds ratio, 0.66; 95% confidence interval, 0.51-0.86).

Conclusion: Approximately half of obstetrical patients with at least 2 documented severely elevated blood pressure measurements did not receive the recommended antihypertensive treatment. Of those who did receive treatment, about 40% had delayed treatment. Black and Hispanic race and preterm gestation were associated with an increased likelihood of receiving the recommended treatment when compared with White race and term pregnancies. Patients whose severe obstetrical hypertension emergency occurred overnight and those who were postpartum were less likely to receive any first-line antihypertensive treatment. Overall, patients without sociodemographic and clinical risk factors for severe obstetrical hypertension or other pregnancy complications were less likely to be treated. However, treatment improved significantly over time with the implementation of targeted quality measures and specific institutional policies based on the American College of Obstetricians and Gynecologists' latest severe obstetrical hypertension management guidelines.
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September 2021

Neonatal and maternal outcomes with trial of labor after two prior cesarean births: stratified by history of vaginal birth.

J Matern Fetal Neonatal Med 2021 Apr 1:1-8. Epub 2021 Apr 1.

Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA.

Introduction: To determine the impact of prior vaginal birth on neonatal and maternal outcomes among individuals undergoing a trial of labor after two cesarean births.

Materials And Methods: This was a cross-sectional study using the U.S. National Vital Statistics 2014-2018 period linked birth and infant death data. Inclusion criteria were term, cephalic, singleton pregnancies with two prior cesarean births. The primary exposure variable was a trial of labor after cesarean vs prelabor repeat cesarean birth. Cohorts were defined by the presence or absence of a prior vaginal birth. The primary outcome was a composite of adverse neonatal outcomes (Apgar score <5 at 5 min, assisted ventilation >6 h, neonatal seizures, or neonatal death within 27 days). Secondary outcomes included a maternal composite and the cesarean birth rate. Propensity score matching was used to account for baseline differences in treatment allocation within each cohort, and conditional logistic regression assessed the association between the exposure and outcomes.

Results: The composite neonatal adverse outcome was significantly higher in those undergoing a trial of labor after cesarean compared to prelabor repeat cesarean birth in both individuals without a prior vaginal birth (8.2 vs 11.6 per 1000 live births, OR 1.41; 95% CI 1.12-1.70) and with a prior vaginal birth (9.6 vs 12.4 per 1000 live births, OR 1.30; 95% CI 1.08-1.57). The composite maternal adverse outcome was significantly higher among individuals without a prior vaginal birth undergoing trial of labor after cesarean (6.0 vs 9.5 per 1000 live births, OR 1.59; 95% CI 1.26-2.09), but was similar in those with a prior vaginal birth (7.9 vs 9.3 per 1000 live births, OR 1.18; 95% CI 0.97-1.46).

Conclusion: In individuals with two prior cesarean births, trial of labor after cesarean was associated with increased neonatal adverse outcomes when compared to prelabor repeat cesarean birth, irrespective of a history of vaginal birth. In individuals with a prior vaginal birth, the composite maternal adverse outcome was not elevated in the trial of labor cohort.
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April 2021

Shoulder dystocia and composite adverse outcomes for the maternal-neonatal dyad.

Am J Obstet Gynecol MFM 2021 07 20;3(4):100359. Epub 2021 Mar 20.

Department of Obstetrics, Gynecology and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX (Drs Mendez-Figueroa, Blackwell, and Chauhan). Electronic address:

Background: Although the neonatal morbidity associated with shoulder dystocia are well known, the maternal morbidity caused by this obstetrical emergency is infrequently reported.

Objective: This study aimed to assess the composite adverse maternal and neonatal outcomes among vaginal deliveries (at 34 weeks or later) with and without shoulder dystocia.

Study Design: This is a secondary analysis of the Consortium of Safe Labor, an observational obstetrical cohort of all vaginal deliveries occurring at 19 hospitals (from 2002-2008) and for which data on the occurrence of shoulder dystocia were available. The composite adverse maternal outcome included third- or fourth-degree perineal laceration, postpartum hemorrhage (>500 cc blood loss for a vaginal delivery and >1000 cc blood loss for cesarean delivery), blood transfusion, chorioamnionitis, endometritis, thromboembolism, admission to intensive care unit, or maternal death. The composite adverse neonatal outcome included an Apgar score of <7 at 5 minutes, a birth injury, neonatal seizure, hypoxic ischemic encephalopathy, or neonatal death. A multivariable Poisson regression was used to estimate the adjusted relative risks with 95% confidence intervals. The area under the receiver operating characteristic curve was constructed to determine if clinical factors would identify shoulder dystocia.

Results: Of the 228,438 women in the overall cohort, 130,008 (59.6%) met the inclusion criteria, and among them, shoulder dystocia was documented in 2159 (1.7%) cases. The rate of composite maternal morbidity was significantly higher among deliveries with shoulder dystocia (14.7%) than without (8.6%; adjusted relative risk, 1.71; 95% confidence interval, 1.64-2.01). The most common maternal morbidity with shoulder dystocia was a third- or fourth-degree laceration (adjusted relative risk, 2.82; 95% confidence interval, 2.39-3.31). The risk of composite neonatal morbidity with shoulder dystocia (12.2%) was also significantly higher than without shoulder dystocia (2.4%) (adjusted relative risk, 5.18; 95% confidence interval, 4.60-5.84). The most common neonatal morbidity was birth injury (adjusted relative risk, 5.39; 95% confidence interval, 4.71-6.17). The area under the curve for maternal characteristics to identify shoulder dystocia was 0.66 and it was 0.67 for intrapartum factors.

Conclusion: Although shoulder dystocia is unpredictable, the associated morbidity affects both mothers and newborns. The focus should be on concurrently averting the composite morbidity for the maternal-neonatal dyad with shoulder dystocia.
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July 2021

Association of Breastfeeding and Child IQ Score at Age 5 Years.

Obstet Gynecol 2021 04;137(4):561-570

Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Texas, Southwestern, Dallas, Texas, University of Utah Health Sciences Center, Salt Lake City, Utah, Wayne State University, Detroit, Michigan, Columbia University, New York, New York, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Medical Branch at Galveston, Galveston, Texas, University of Alabama at Birmingham, Birmingham, Alabama, Brown University, Providence, Rhode Island, University of Texas, Houston, Houston, Texas, Case Western Reserve University, Cleveland, Ohio, Oregon Health & Science University, Portland, OR, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To evaluate whether breastfeeding and its duration are associated with a reduced risk of low IQ scores or other neurodevelopmental problems.

Methods: We conducted a secondary analysis of two parallel multicenter, double-blinded randomized controlled trials in which participants with a singleton pregnancy and either subclinical hypothyroidism or hypothyroxinemia were treated with thyroxine or placebo. Our primary outcome was a low IQ score (less than 85 on the WPPSI-III [Wechsler Preschool and Primary Scale of Intelligence III] at age 5 years). Secondary outcomes included performance measures on other validated neurodevelopmental tests. Univariable and multivariable analyses were performed to evaluate the association between breastfeeding and neurodevelopmental outcomes. Stepwise backward proceeding linear and logistic regression models were used to develop the final adjusted models.

Results: Of the 772 participants studied, 614 (80%) reported breastfeeding. Of these, 31% reported breastfeeding for less than 4 months, 19% for 4-6 months, 11% for 7-9 months, 15% for 10-12 months and 23% for more than 12 months. IQ scores were available for 756 children; mean age-5 scores were higher with any breastfeeding (96.7±15.1) than without (91.2±15.0, mean difference 5.5, 95% CI 2.8-8.2), and low IQ scores were less frequent with any breastfeeding (21.5%) than with no breastfeeding (36.2%, odds ratio 0.48, 95% CI 0.33-0.71). In adjusted analyses, breastfeeding remained associated with reduced odds of low IQ score (adjusted odds ratio [aOR] 0.62, 95% CI 0.41-0.93), and each additional month of breastfeeding was associated with lower odds of a low IQ scores (aOR 0.97, 95% CI 0.939-0.996). No significant associations between breastfeeding and other neurodevelopmental outcomes were identified in adjusted analyses.

Conclusion: Breastfeeding and its duration are associated with lower odds of low IQ score at age 5 years.
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http://dx.doi.org/10.1097/AOG.0000000000004314DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8104129PMC
April 2021

Early Pregnancy Atherogenic Profile in a First Pregnancy and Hypertension Risk 2 to 7 Years After Delivery.

J Am Heart Assoc 2021 02 23;10(5):e017216. Epub 2021 Feb 23.

Northwestern University Feinberg School of Medicine Chicago IL.

Background Cardiovascular risk in young adulthood is an important determinant of lifetime cardiovascular disease risk. Women with adverse pregnancy outcomes (APOs) have increased cardiovascular risk, but the relationship of other factors is unknown. Methods and Results Among 4471 primiparous women, we related first-trimester atherogenic markers to risk of APO (hypertensive disorders of pregnancy, preterm birth, small for gestational age), gestational diabetes mellitus (GDM) and hypertension (130/80 mm Hg or antihypertensive use) 2 to 7 years after delivery. Women with an APO/GDM (n=1102) had more atherogenic characteristics (obesity [34.2 versus 19.5%], higher blood pressure [systolic blood pressure 112.2 versus 108.4, diastolic blood pressure 69.2 versus 66.6 mm Hg], glucose [5.0 versus 4.8 mmol/L], insulin [77.6 versus 60.1 pmol/L], triglycerides [1.4 versus 1.3 mmol/L], and high-sensitivity C-reactive protein [5.6 versus 4.0 nmol/L], and lower high-density lipoprotein cholesterol [1.8 versus 1.9 mmol/L]; <0.05) than women without an APO/GDM. They were also more likely to develop hypertension after delivery (32.8% versus 18.1%, <0.05). Accounting for confounders and factors routinely assessed antepartum, higher glucose (relative risk [RR] 1.03 [95% CI, 1.00-1.06] per 0.6 mmol/L), high-sensitivity C-reactive protein (RR, 1.06 [95% CI, 1.02-1.11] per 2-fold higher), and triglycerides (RR, 1.27 [95% CI, 1.14-1.41] per 2-fold higher) were associated with later hypertension. Higher physical activity was protective (RR, 0.93 [95% CI, 0.87-0.99] per 3 h/week). When evaluated as latent profiles, the nonobese group with higher lipids, high-sensitivity C-reactive protein, and insulin values (6.9% of the cohort) had increased risk of an APO/GDM and later hypertension. Among these factors, 7% to 15% of excess RR was related to APO/GDM. Conclusions Individual and combined first-trimester atherogenic characteristics are associated with APO/GDM occurrence and hypertension 2 to 7 years later. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02231398.
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http://dx.doi.org/10.1161/JAHA.120.017216DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174276PMC
February 2021

Maternal and Perinatal Outcomes of Expectant Management of Full-Term, Low-Risk, Nulliparous Patients.

Obstet Gynecol 2021 02;137(2):250-257

Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, Metro Health Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas; University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To compare risks of maternal and perinatal outcomes by completed week of gestation from 39 weeks in low-risk nulliparous patients undergoing expectant management.

Methods: 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.

Results: 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.

Conclusion: 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.
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http://dx.doi.org/10.1097/AOG.0000000000004230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8404416PMC
February 2021

Later sleep timing is associated with an increased risk of preterm birth in nulliparous women.

Am J Obstet Gynecol MFM 2019 11 9;1(4):100040. Epub 2019 Sep 9.

Department of Obstetrics, Gynecology-Maternal Fetal Medicine & Preventive Medicine, Northwestern University, Chicago, IL.

Background: Although uterine contractions have a diurnal periodicity and increase in frequency during hours of darkness, data on the relationship between sleep duration and sleep timing patterns and preterm birth are limited.

Objective: We sought to examine the relationship of self-reported sleep duration and timing in pregnancy with preterm birth.

Study Design: In the prospective Nulliparous Pregnancy Outcome Study: Monitoring Mothers-to-be cohort, women completed a survey of sleep patterns at 6-13 weeks gestation (visit 1) and again at 22-29 weeks gestation (visit 3). Additionally, at 16-21 weeks gestation (visit 2), a subgroup completed a weeklong actigraphy recording of their sleep. Weekly averages of self-reported sleep duration and sleep midpoint were calculated. A priori, sleep duration of <7 hours was defined as "short," and sleep midpoint after 5 am was defined as "late." The relationships among these sleep characteristics and all preterm birth and spontaneous preterm birth at <37 weeks gestation were examined in univariate analyses. Multivariable logistic regressions that controlled for age and body mass index alone (model 1) and with additional covariates (race, smoking, insurance, and employment schedule) following a backward elimination process (model 2) were performed.

Results: Of the 10,038 women who were enrolled, sleep survey data were available on 7524 women at visit 1 and 7668 women at visit 3. The rate of short sleep duration was 17.1% at visit 1 and 20.7% at visit 3. The proportion with a late sleep midpoint was 11.6% at visit 1 and 12.2% at visit 3. There was no significant relationship between self-reported short sleep and preterm birth across all visits. However, self-reported late sleep midpoint (>5 am) was associated with preterm birth . Women with a late sleep midpoint (>5 am) in early pregnancy had a preterm birth rate of 9.5%, compared with 6.9% for women with sleep midpoint ≤5 am (P=.005). Similarly, women with a late sleep midpoint had a higher rate of spontaneous preterm birth (6.2% vs 4.4%; P=.019). Comparable results were observed for women with a late sleep midpoint at visit 3 (all preterm birth 8.9% vs 6.6%; P=.009; spontaneous preterm birth 5.9% vs 4.3%; P=.023). All adjusted analyses on self-reported sleep midpoint (models 1 and 2) maintained statistical significance (P<.05), except for visit 1, model 2 for spontaneous preterm birth (P=.07). The visit 2 objective data from the smaller subgroup (n=782) demonstrated similar trends in preterm birth rates by sleep midpoint status.

Conclusion: Self-reported late sleep midpoint in both early and late pregnancy, but not short sleep duration, is associated with an increased rate of preterm birth.
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http://dx.doi.org/10.1016/j.ajogmf.2019.100040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757682PMC
November 2019

Perinatal outcomes in women with elevated blood pressure and stage 1 hypertension.

Am J Obstet Gynecol 2021 05 4;224(5):521.e1-521.e11. Epub 2020 Nov 4.

Department of Obstetrics, Gynecology, and Reproductive Science, Yale University, New Haven, CT.

Background: Hypertension was redefined in 2017 with lower diagnostic thresholds; elevated blood pressure is defined as systolic blood pressure of 120 to 129 mm Hg with diastolic blood pressure of <80 mm Hg and stage 1 hypertension as systolic blood pressure of 130 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg. These guidelines did not include pregnant women. There is limited information on stage 1 hypertension and pregnancy outcomes.

Objective: This study aimed to determine whether elevated blood pressure and stage 1 hypertension as newly defined by the 2017 American College of Cardiology and the American Heart Association guidelines are associated with an increased risk of hypertensive disorders of pregnancy and other adverse maternal and neonatal outcomes.

Study Design: In this retrospective cohort study, 18,801 women with singletons from 2013 to 2019 were categorized as normotensive, prehypertensive (elevated blood pressure), stage 1 hypertensive, or chronic hypertensive. Women with ≥2 systolic blood pressures of 120 to 129 mm Hg before 20 weeks' gestation were classified into the elevated blood pressure group. Women with ≥2 systolic blood pressures of 130 to 139 mm Hg or ≥2 diastolic blood pressures of 80 to 89 mm Hg before 20 weeks' gestation were assigned to the stage 1 hypertension group. Women were classified as chronic hypertensives if they had any of the following: ≥2 systolic blood pressure of ≥140 mm Hg or ≥2 diastolic blood pressure of ≥90 mm Hg before 20 weeks' gestation, a history of chronic hypertension, or antihypertensive medication use before 20 weeks' gestation. Women with pregestational diabetes, lupus, or <2 blood pressures before 20 weeks' gestation were excluded. The association of stage 1 hypertension with the risk of developing hypertensive disorders of pregnancy was estimated using multivariate logistic regression controlling for maternal sociodemographic characteristics, gestational weight gain by prepregnancy body mass index, parity, and aspirin use. Secondary outcomes included subgroups of hypertensive disorders (gestational hypertension, preeclampsia, eclampsia, and hemolysis, elevated liver enzymes, and low platelet count syndrome), gestational diabetes, placental abruption, intrauterine growth restriction, preterm birth, neonatal intensive care unit admission, stillbirth and neonatal death, and maternal intensive care unit admission. All outcomes were adjusted for potential confounders.

Results: Of the 18,801 women, 13,478 (71.7%) were normotensive, 2659 (14.1%) had elevated blood pressure, 1384 (7.4%) were stage 1 hypertensive, and 1280 (6.8%) were chronic hypertensive. A dose-response relationship was observed: the risk of hypertensive disorders of pregnancy increased from 4.2% in normotensive women to 6.7% (adjusted odds ratio, 1.50; 95% confidence interval, 1.26-1.79) in women with elevated blood pressure, to 10.9% (adjusted odds ratio, 2.54; 95% confidence interval, 2.09-3.08) in women with stage 1 hypertension, and 28.4% (adjusted odds ratio, 7.14; 95% confidence interval, 6.06-8.40) in women with chronic hypertension. Compared with normotensive women, women with stage 1 hypertension had an increased risk of neonatal intensive care unit admissions (15.8% vs 13.0%; adjusted odds ratio, 1.21; 95% confidence interval, 1.03-1.42), preterm birth at <37 weeks' gestation (7.2% vs 5.2%; adjusted odds ratio, 1.45; 95% confidence interval, 1.16-1.81), and gestational diabetes (14.8% vs 6.8%; adjusted odds ratio, 2.68; 95% confidence interval, 2.27-3.17).

Conclusion: Our study demonstrates that elevated blood pressure and stage 1 hypertension, using the 2017 American College of Cardiology and the American Heart Association guideline definition, are associated with increased maternal and neonatal risk. This group of women warrants further investigation to determine whether pregnancy management can be altered to reduce maternal and neonatal morbidity.
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May 2021

Characteristics of Stillbirths Associated With Diabetes in a Diverse U.S. Cohort.

Obstet Gynecol 2020 12;136(6):1095-1102

University of Utah Health, Salt Lake City, Utah; Intermountain Health Care, Murray, Utah; Northwestern University, Feinberg School of Medicine, Chicago, Illinois; RTI International, Research Triangle Park, North Carolina; the University of Health Sciences, Van Training and Research Hospital, Van, Turkey; University of Virginia Healthcare, Charlottesville, Virginia; the University of Texas Medical Branch at Galveston, Galveston, Texas; Columbia University, New York, New York; the University of Texas Health Science Center at Houston, Houston, Texas; the Rollins School of Public Health, Emory University, Atlanta, Georgia; the University of Texas at Austin, Austin, Texas; the University of Texas Health Science Center at San Antonio, San Antonio, Texas; Brown University, Providence, Rhode Island; and Yale School of Medicine, New Haven, Connecticut.

Objective: To characterize stillbirths associated with pregestational diabetes and gestational diabetes mellitus (GDM) in a large, prospective, U.S. case-control study.

Methods: A secondary analysis of stillbirths among patients enrolled in a prospective; multisite; geographically, racially, and ethnically diverse case-control study in the United States was performed. Singleton gestations with complete information regarding diabetes status and with a complete postmortem evaluation were included. A standard evaluation protocol for stillbirth cases included postmortem evaluation, placental pathology, clinical testing as performed at the discretion of the health care professional, and a recommended panel of tests. A potential cause of death was assigned to stillbirth cases using a standardized classification tool. Demographic and delivery characteristics among women with pregestational diabetes and GDM were compared with characteristics of women with no diabetes in pairwise comparisons using χ or two-sample t tests as appropriate. Sensitivity analysis was performed excluding pregnancies with genetic conditions or major fetal malformations.

Results: Of 455 stillbirth cases included in the primary analysis, women with stillbirth and diabetes were more likely to be older than 35 years and have a higher body mass index. They were also more likely to have a gestational hypertensive disorder than women without diabetes (28% vs 9.1%; P<.001). Women with pregestational diabetes had more large-for-gestational-age (LGA) neonates (26% vs 3.4%; P<.001). Stillbirths occurred more often at term in women with pregestational diabetes (36%) and those with GDM (52%). Maternal medical complications, including pregestational diabetes and others, were more often identified as a probable or possible cause of death among stillbirths with maternal diabetes (43% vs 4%, P<.001) as compared with stillbirths without diabetes.

Conclusion: Compared with stillbirths in women with no diabetes, stillbirths among women with pregestational diabetes and GDM occur later in pregnancy and are associated with hypertensive disorders of pregnancy, maternal medical complications, and LGA.
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http://dx.doi.org/10.1097/AOG.0000000000004117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7680368PMC
December 2020

Exome sequencing analysis on products of conception: a cohort study to evaluate clinical utility and genetic etiology for pregnancy loss.

Genet Med 2021 03 26;23(3):435-442. Epub 2020 Oct 26.

Departments of Genetics, Yale School of Medicine, New Haven, CT, USA.

Purpose: Pregnancy loss ranging from spontaneous abortion (SAB) to stillbirth can result from monogenic causes of Mendelian inheritance. This study evaluated the clinical application of exome sequencing (ES) in identifying the genetic etiology for pregnancy loss.

Methods: A cohort of 102 specimens from products of conception (POC) with normal karyotype and absence of pathogenic copy-number variants were selected for ES. Abnormality detection rate (ADR) and variants of diagnostic value correlated with SAB and stillbirth were evaluated.

Results: ES detected 6 pathogenic variants, 16 likely pathogenic variants, and 17 variants of uncertain significance favor pathogenic (VUSfp) from this cohort. The ADR for pathogenic and likely pathogenic variants was 22% and reached 35% with the inclusion of VUSfp. The ADRs of SAB and stillbirth were 36% and 33%, respectively. Affected genes included those associated with multisystem abnormalities, neurodevelopmental disorders, cardiac anomalies, skeletal dysplasia, metabolic disorders, and renal diseases.

Conclusion: These results supported the clinical utility of ES for detecting monogenic etiology of pregnancy loss. The identification of disease-associated variants provided information for follow-up genetic counseling of recurrence risk and management of subsequent pregnancies. Discovery of novel variants could provide insight for underlying molecular mechanisms causing fetal death.
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http://dx.doi.org/10.1038/s41436-020-01008-6DOI Listing
March 2021

A Model to Predict Vaginal Delivery and Maternal and Neonatal Morbidity in Low-Risk Nulliparous Patients at Term.

Am J Perinatol 2020 Oct 19. Epub 2020 Oct 19.

Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.

Objective:  This study aimed to develop and validate a model to predict the probability of vaginal delivery (VD) in low-risk term nulliparous patients, and to determine whether it can predict the risk of severe maternal and neonatal morbidity.

Methods:  Secondary analysis of an obstetric cohort of patients and their neonates born in 25 hospitals across the United States ( = 115,502). Trained and certified research personnel abstracted the maternal and neonatal records. Nulliparous patients with singleton, nonanomalous vertex fetuses, admitted with an intent for VD ≥ 37 weeks were included in this analysis. Patients in active labor (cervical exam > 5 cm), those with prior cesarean and other comorbidities were excluded. Eligible patients were randomly divided into a training and test sets. Based on the training set, and using factors available at the time of admission for delivery, we developed and validated a logistic regression model to predict the probability of VD, and then estimated the prevalences of severe morbidity according to the predicted probability of VD.

Results:  A total of 19,611 patients were included. Based on the training set ( = 9,739), a logistic regression model was developed that included maternal age, body mass index (BMI), cervical dilatation, and gestational age on admission. The model was internally validated on the test set ( = 9,872 patients) and yielded a receiver operating characteristic-area under the curve (ROC-AUC) of 0.71 (95% confidence interval [CI]: 0.70-0.72). Based on a subset of 18,803 patients with calculated predicted probabilities, we demonstrated that the prevalences of severe morbidity decreased as the predicted probability of VD increased ( < 0.01).

Conclusion:  In a large cohort of low-risk nulliparous patients in early labor or undergoing induction of labor, at term with singleton gestations, we developed and validated a model to calculate the probability of VD, and maternal and neonatal morbidity. If externally validated, this calculator may be clinically useful in helping to direct level of care, staffing, and adjustment for case-mix among various systems.

Key Points: · A model to predict the probability of vaginal delivery in low-risk nulliparous patients at term.. · The model also predicts the risk of severe maternal and neonatal morbidity.. · The prevalences of severe morbidity decrease as the probability of vaginal delivery increases..
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http://dx.doi.org/10.1055/s-0040-1718704DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053722PMC
October 2020

Coronavirus disease 2019 pregnancy outcomes in a racially and ethnically diverse population.

Am J Obstet Gynecol MFM 2020 11 7;2(4):100246. Epub 2020 Oct 7.

Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, Yale University, New Haven, CT.

Background: Older age and medical comorbidities are identified risk factors for developing severe coronavirus disease 2019. However, there are limited data on risk stratification, clinical and laboratory course, and optimal management of coronavirus disease 2019 in pregnancy.

Objective: Our study aimed to describe the clinical course of coronavirus disease 2019, effect of comorbidities on disease severity, laboratory trends, and pregnancy outcomes of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2-positive pregnant women.

Study Design: This is a case series of pregnant and postpartum women who received positive test results for severe acute respiratory syndrome coronavirus 2 between March 3, 2020, and May 11, 2020, within 3 hospitals of the Yale New Haven Health delivery network. Charts were reviewed for basic sociodemographic and prepregnancy characteristics, coronavirus disease 2019 course, laboratory values, and pregnancy outcomes.

Results: Of the 1567 tested pregnant and postpartum women between March 3, 2020, and May 11, 2020, 9% (n=141) had a positive severe acute respiratory syndrome coronavirus 2 result. Hispanic women were overrepresented in the severe acute respiratory syndrome coronavirus 2-positive group (n=61; 43.8%). In addition, Hispanic ethnicity was associated with a higher rate of moderate and severe diseases than non-Hispanic (18% [11/61] vs 3.8% [3/78], respectively; odds ratio, 5.5; 95% confidence interval, 1.46-20.7; =.01). Of note, 44 women (31.2%) were asymptomatic, 37 of whom (26.2%) were diagnosed on universal screening upon admission for delivery. Moreover, 59% (n=83) were diagnosed before delivery, 36% (n=51) upon presentation for childbirth, and 5% (n=7) after delivery. Severe disease was diagnosed in 6 cases (4.3%), and there was 1 maternal death. Obese women were more likely to develop moderate and severe diseases than nonobese women (16.4% [9/55] vs 3.8% [3/79]; odds ratio, 4.96; 95% confidence interval, 1.28-19.25; =.02). Hypertensive disorders of pregnancy were diagnosed in 22.3% of women (17/77) who delivered after 20 weeks' gestation. Higher levels of C-reactive protein during antepartum coronavirus disease 2019-related admission were more common in women with worse clinical course; however, this association did not reach statistical significance.

Conclusion: Coronavirus disease 2019 in pregnancy may result in severe disease and death. Hispanic women were more likely to receive a positive test result for severe acute respiratory syndrome 2 than other ethnic groups. Obesity and Hispanic ethnicity represent risk factors for moderate and severe diseases.
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http://dx.doi.org/10.1016/j.ajogmf.2020.100246DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539936PMC
November 2020

Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation.

Obstet Gynecol 2020 10;136(4):698-705

Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

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.
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http://dx.doi.org/10.1097/AOG.0000000000004046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899015PMC
October 2020

Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women.

Obstet Gynecol 2020 10;136(4):692-697

Departments of Obstetrics and Gynecology, Stanford University, Stanford, California, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

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.
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http://dx.doi.org/10.1097/AOG.0000000000004055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529933PMC
October 2020

Externally Validated Prediction Model of Vaginal Delivery After Preterm Induction With Unfavorable Cervix.

Obstet Gynecol 2020 10;136(4):716-724

Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, MedStar Washington Hospital Center, Washington, DC; the Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Science, Yale University, New Haven, Connecticut; the Department of Biostatistics and Bioinformatics, MedStar Health Research Institute, Hyattsville, Maryland; the Georgetown-Howard Universities Center for Clinical and Translational Science, Washington, DC; and the MedStar Simulation Training & Education Lab, Washington, DC.

Objective: To create and externally validate a predictive model to calculate the likelihood of vaginal delivery after preterm induction with unfavorable cervix.

Methods: This was a retrospective cohort study of women with a singleton gestation from a single academic institution who underwent an induction of labor at less than 37 weeks of gestation from January 2009 to June 2018. Women with contraindications for vaginal delivery were excluded. Analyses were limited to women with unfavorable cervix (both simplified Bishop score [dilation, station, and effacement: range 0-9] less than 6 and cervical dilation less than 3 cm). A stepwise logistic regression analysis was used to identify the factors associated with vaginal delivery by considering maternal characteristics and comorbidities as well as fetal conditions. The final model was validated using an external data set of the Consortium on Safe Labor after applying the same inclusion and exclusion criteria. We compared the area under the curve (AUC) of our predictive model and the simplified Bishop score.

Results: Of the 835 women, 563 (67%) had vaginal delivery. Factors associated with vaginal delivery included later gestational age at delivery, higher parity, more favorable simplified Bishop score, and preterm prelabor rupture of membranes. Factors including older maternal age, non-Hispanic Black race, higher body mass index, and abruption were associated with decreased likelihood of vaginal delivery. In the external validation cohort, 1,899 women were analyzed, of whom 1,417 (75%) had vaginal delivery. The AUCs of simplified Bishop score and the final model were 0.65 (95% CI 0.59-0.66) and 0.73 (95% CI 0.72-0.79), respectively, for the external validation cohort. The online calculator was created and is available at www.medstarapps.org/obstetricriskcalculator/ and in the Obstetric Risk Calculator mobile application in the Apple App Store and Google Play Store.

Conclusion: Our externally validated model was efficient in predicting vaginal delivery after preterm induction with unfavorable cervix.
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October 2020

Optimal timing of antenatal corticosteroid administration and preterm neonatal and early childhood outcomes.

Am J Obstet Gynecol MFM 2020 02 17;2(1):100077. Epub 2019 Dec 17.

Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of North Carolina-Chapel Hill, Chapel Hill, NC.

Background: Antenatal corticosteroids reduce morbidity and mortality among preterm neonates. However, the optimal timing of steroid administration with regards to severe neonatal and early childhood morbidity is uncertain.

Objective: To evaluate the association between the timing of antenatal corticosteroid adminstration and preterm outcomes. We hypothesized that neonates exposed to antenatal corticosteroids 2 to <7 days before delivery would have the lowest risks of neonatal and childhood morbidity.

Study Design: Secondary analysis of two prospective multicenter studies enriched for spontaneous preterm birth, Genomics and Proteomics Network for Preterm Birth Research (11/2007-1/2011) and Beneficial Effect of Antenatal Magnesium (12/1997-5/2004). We included women with singleton gestations who received antenatal corticosteroids and delivered at 23 0/7-33 6/7 weeks' gestation. Women who received ≥1 course of corticosteroids were excluded. Neonatal outcomes were compared by the timing of the first dose of antenatal corticosteroids in relation to delivery: <2 days, 2 to <7 days, 7 to <14 days, and ≥14 days. The primary outcome was respiratory distress syndrome. Secondary outcomes included composite neonatal morbidity (death, intraventricular hemorrhage grade III or IV, periventricular leukomalacia, bronchopulmonary dysplasia, or necrotizing enterocolitis), and early childhood morbidity (death or moderate to severe cerebral palsy at age 2). Multivariable logistic regression estimated the association between timing of antenatal corticosteroid administration and study outcomes.

Results: A total of 2,259 subjects met inclusion criteria: 622 (27.5%) received antenatal corticosteroids <2 days before delivery, 821 (36.3%) 2 to <7 days, 401 (17.8%) 7 to <14 days, and 415 (18.4%) ≥14 days. The majority (78.1%) delivered following idiopathic spontaneous preterm labor or preterm premature rupture of membranes at a mean gestational age of 29.5 +/-2.8 weeks. Neonates exposed to antenatal corticosteroids 2 to <7 days before delivery were the least likely to develop respiratory distress syndrome (51.3%), compared to those receiving antenatal corticosteroids <2 days, 7 to <14 days, and ≥14 days before delivery (62.7%, 55.9%, and 57.6%, respectively, p<0.001). Compared to receipt 2 to <7 days before delivery, there was an increased odds of respiratory distress syndrome with receipt of antenatal corticosteroids <2 days (aOR 2.07, 95%CI 1.61-2.66), 7 to <14 days (aOR 1.40, 95% CI 1.07-1.83), and ≥14 days (aOR 2.34, 95%CI 1.78-3.07). Neonates exposed to antenatal corticosteroids ≥14 days before delivery were at increased odds for severe neonatal morbidity (aOR 1.57, 95%CI 1.12-2.19) and early childhood morbidity (aOR 1.74, 95%CI 1.02-2.95), compared to those exposed 2 to <7 days before delivery. There was no significant association between antenatal corticosteroid receipt <2 days or 7 to <14 days and severe neonatal morbidity or severe childhood morbidity.

Conclusions: Preterm neonates exposed to antenatal corticosteroids 2 to <7 days before delivery had the lowest odds of respiratory distress syndrome, compared to shorter and longer time intervals between steroid administration and delivery. Antenatal corticosteroid administration ≥14 days before delivery is associated with an increased odds of severe neonatal and childhood morbidity, compared to 2 to <7 days before delivery. These results emphasize the importance of optimally timed antenatal corticosteroids to improve both short- and long-term outcomes.
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http://dx.doi.org/10.1016/j.ajogmf.2019.100077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7469940PMC
February 2020

Causal Genetic Variants in Stillbirth.

N Engl J Med 2020 09 12;383(12):1107-1116. Epub 2020 Aug 12.

From the Institute for Genomic Medicine at Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center (K.E.S., J.G., A.R.-P., M.E., N.L., H.H., G.P., J.H., V.A., R.J.W., D.B.G.), and the Departments of Obstetrics and Gynecology (J.G., R.G., R.J.W.) and Pathology and Cell Biology (C.B., A.T., M.G., J.L., A.V.D., V.A.), Columbia University Medical Center, New York; RTI International, Research Triangle Park (V.T., C.B.P.), and the Department of Biostatistics and Bioinformatics, Duke University, Durham (A.S.A.) - both in North Carolina; the Departments of Obstetrics and Gynecology and Cell Biology, University of Texas Medical Branch, Galveston (G.R.S.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville (D.J.D.); the Division of Perinatal and Pediatric Pathology, Women and Infants Hospital, Warren Alpert School of Medicine of Brown University, Providence, RI (H.P.); Rollins School of Public Health, Emory University, Atlanta (C.H.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Pregnancy and Perinatology Branch, Bethesda, MD (U.M.R.); and the University of Utah and Intermountain Healthcare, Salt Lake City (R.M.S.).

Background: In the majority of cases, the cause of stillbirth remains unknown despite detailed clinical and laboratory evaluation. Approximately 10 to 20% of stillbirths are attributed to chromosomal abnormalities. However, the causal nature of single-nucleotide variants and small insertions and deletions in exomes has been understudied.

Methods: We generated exome sequencing data for 246 stillborn cases and followed established guidelines to identify causal variants in disease-associated genes. These genes included those that have been associated with stillbirth and strong candidate genes. We also evaluated the contribution of 18,653 genes in case-control analyses stratified according to the degree of depletion of functional variation (described here as "intolerance" to variation).

Results: We identified molecular diagnoses in 15 of 246 cases of stillbirth (6.1%) involving seven genes that have been implicated in stillbirth and six disease genes that are good candidates for phenotypic expansion. Among the cases we evaluated, we also found an enrichment of loss-of-function variants in genes that are intolerant to such variation in the human population (odds ratio, 2.15; 95% confidence interval [CI], 1.46 to 3.06). Loss-of-function variants in intolerant genes were concentrated in genes that have not been associated with human disease (odds ratio, 2.22; 95% CI, 1.41 to 3.34), findings that differ from those in two postnatal clinical populations that were also evaluated in this study.

Conclusions: Our findings establish the diagnostic utility of clinical exome sequencing to evaluate the role of small genomic changes in stillbirth. The strength of the novel risk signal (as generated through the stratified analysis) was similar to that in known disease genes, which indicates that the genetic cause of stillbirth remains largely unknown. (Funded by the Institute for Genomic Medicine.).
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http://dx.doi.org/10.1056/NEJMoa1908753DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7604888PMC
September 2020

Neonatal and Maternal Composite Adverse Outcomes Among Low-Risk Nulliparous Women Compared With Multiparous Women at 39-41 Weeks of Gestation.

Obstet Gynecol 2020 09;136(3):450-457

Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas, Northwestern University, Chicago, Illinois, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch, Galveston, Texas, Wayne State University, Detroit, Michigan, Brown University, Providence, Rhode Island, and Oregon Health & Science University, Portland, Oregon; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To estimate whether the frequency of adverse maternal and neonatal outcomes differs between low-risk nulliparous and multiparous women at 39-41 weeks of gestation.

Methods: This is a secondary analysis of an observational obstetrics cohort of maternal-neonatal dyads at 25 hospitals. Low-risk women with nonanomalous singletons who delivered between 39 0/7 and 41 6/7 weeks of gestation were included. The composite neonatal adverse outcome included 5-minute Apgar score less than five, ventilator support or cardiopulmonary resuscitation, seizure, hypoxic ischemic encephalopathy, sepsis, bronchopulmonary dysplasia, persistent pulmonary hypertension, necrotizing enterocolitis, birth injury or perinatal death. The composite maternal adverse outcome included infection, third- or fourth-degree perineal laceration, thromboembolism, transfusion of blood products, or maternal death. Small for gestational age (SGA), large for gestational age (LGA), and shoulder dystocia requiring maneuvers were also evaluated. Multivariable regression was used to estimate adjusted relative risks (aRRs) and adjusted odds ratios (aORs) with 95% CIs.

Results: Of the 115,502 women in the overall cohort, 39,870 (34.5%) met eligibility criteria for this analysis; 18,245 (45.8%) were nulliparous. The risk of the composite neonatal adverse outcome (1.5% vs 1.0%, aRR 1.80, 95% CI 1.48-2.19), composite maternal adverse outcome (15.1% vs 3.3%, aRR 5.04, 95% CI 4.62-5.49), and SGA (8.9% vs 5.8%, aOR 1.45, 95% CI 1.33-1.57) was significantly higher in nulliparous than multiparous patients. The risk of LGA (aOR 0.65, 95% CI 0.60-0.71) and shoulder dystocia with maneuvers (aRR 0.68, 95% CI 0.60-0.77) was significantly lower in nulliparous rather than multiparous patients.

Conclusion: The risk of composite adverse outcomes and SGA among low-risk nulliparous women at 39-41 weeks of gestation is significantly higher than among multiparous counterparts. However, nulliparous women had a lower risk of shoulder dystocia with maneuvers and LGA.
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http://dx.doi.org/10.1097/AOG.0000000000003951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483669PMC
September 2020

Antenatal Corticosteroids and Preterm Neonatal Morbidity and Mortality among Women with and without Diabetes in Pregnancy.

Am J Perinatol 2020 Jul 27. Epub 2020 Jul 27.

Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.

Objective:  The objective of this study was to determine whether antenatal corticosteroid exposure has a differential association with preterm neonatal morbidity among women with and without diabetes.

Study Design:  Secondary analysis of an observational cohort of 115,502 women and their neonates born in 25 U.S. hospitals (2008-2011). Women who delivered at 23 to 33 weeks' gestation and received antenatal corticosteroids were compared with those who did not receive antenatal corticosteroids. Women with a stillbirth and women who delivered a neonate that was not resuscitated were excluded. The primary outcome was neonatal respiratory distress syndrome or death within 48 hours. Secondary outcomes included composite neonatal morbidity (respiratory distress syndrome, necrotizing enterocolitis, grades 3-4 intraventricular hemorrhage, sepsis, or death) and mechanical ventilation. Multivariable modified Poisson regression was used to estimate the association between antenatal corticosteroid exposure and neonatal outcomes. Maternal diabetes (pregestational and gestational) was evaluated as a potential effect modifier, and sensitivity analyses were conducted to evaluate whether receipt of a partial, single, or multiple course(s) of antenatal corticosteroids influenced results.

Results:  A total of 4,429 women with 5,259 neonates met inclusion criteria: 3,716 (83.9%) women received antenatal corticosteroids and 713 (16.1%) did not. Of the 510 diabetic women (181 pregestational and 329 gestational), 439 (86.1%) received antenatal corticosteroids. Of the 3,919 nondiabetic women, 3,277 (83.6%) received antenatal corticosteroids. Antenatal corticosteroid exposure was not associated with respiratory distress syndrome or early death (adjusted relative risk [aRR] = 0.94, 95% confidence interval [CI]: 0.85-1.04), composite neonatal morbidity (aRR = 0.98, 95% CI: 0.89-1.07), or mechanical ventilation (aRR = 0.95, 95% CI: 0.86-1.05). There was no significant effect modification of maternal diabetes on the relationship between antenatal corticosteroids and neonatal outcomes ( > 0.05), and outcomes were similar in sensitivity analyses of partial, single, or multiple courses of corticosteroids.

Discussion:  Antenatal corticosteroid administered to reduce preterm neonatal morbidity does not appear to have a differential association among women with diabetes compared with those without.

Key Points: · Antenatal corticosteroids are used ubiquitously in women with and without diabetes.. · Maternal diabetes does not appear to modify the neonatal effect of antenatal corticosteroids.. · Larger studies of antenatal corticosteroids are needed to confirm our findings in diabetic women..
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http://dx.doi.org/10.1055/s-0040-1714391DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854806PMC
July 2020

SARS-COV-2 Maternal-Child Transmission: Can It Occur Before Delivery and How Do We Prove It?

Pediatr Infect Dis J 2020 09;39(9):e263-e264

Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.

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September 2020
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