Publications by authors named "George Saade"

530 Publications

Buprenorphine X-waiver exemption - beyond the basics for the obstetric provider.

Am J Obstet Gynecol MFM 2021 Jul 25:100451. Epub 2021 Jul 25.

Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, The Ohio State University College of Medicine, Columbus, OH.

Buprenorphine is one of three medications approved by the US Food and Drug administration for treatment of opioid use disorder, and practitioners must obtain a federal waiver in order to prescribe buprenorphine. Until recently, physicians and advanced practice clinicians were required to complete 8 and 24 hours of training, respectively, before applying for this waiver and to provide psychosocial services when prescribing buprenorphine to 30 or fewer patients. The US Department of Health and Human Services announced in April 2021 that eligible providers would be exempt from the educational requirement for certification, making the waiver more accessible for those intending to prescribe to 30 or fewer patients. Here we review the historical background to the exemption and provide practical guidelines to practitioners caring for obstetric patients with opioid use disorder who are considering applying for the waiver for the first time. Because the educational requirements will no longer be required for X-waiver application, we review fundamental topics and challenging scenarios that are often reviewed in certification courses.
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http://dx.doi.org/10.1016/j.ajogmf.2021.100451DOI Listing
July 2021

A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection.

N Engl J Med 2021 Jul;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
July 2021

Trajectories of antenatal depression and adverse pregnancy outcomes.

Am J Obstet Gynecol 2021 Jul 16. Epub 2021 Jul 16.

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

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

Objective: To identify whether the trajectory of antenatal depressive symptoms is associated with different risks of adverse pregnancy outcomes.

Study Design: This is a secondary analysis of a large multi-site prospective cohort of nulliparous women across the United States. Edinburgh Postpartum Depression Scales (EPDS) were administered at two study visits: between 6-14 weeks and again between 22-30 weeks of gestation. The EPDS score trajectories were categorized as improved, stable, or worsened based on whether the scores changed by at least one standard deviation between the two visits. The frequencies of adverse pregnancy outcomes [hypertensive disorders of pregnancy, abruption, cesarean delivery, preterm birth (i.e., < 37 weeks gestation), small for gestational age neonates, NICU admission, and maternal readmission] were compared according to depression trajectories across gestation in bivariable and multivariable analyses. Secondary analyses evaluated the frequencies of spontaneous and medically-indicated preterm birth, as well as the frequencies of spontaneous and medically-indicated preterm birth before 35, 32, and 28 weeks gestation.

Results: Of the 8,784 women who completed both antenatal EPDS, 1,141 (13.0%) had improved, 6,663 (75.9%) had stable, and 980 (11.2%) had worsened depressive symptom trajectories across gestation. Compared to 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=0.018). After controlling for potential confounders, worsened depressive symptoms remained associated with more frequent preterm birth (aOR 1.68, 95% CI 1.10-2.57).

Conclusions: 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

Associations of the Neighborhood Built Environment with Gestational Weight Gain.

Am J Perinatol 2021 Jun 3. Epub 2021 Jun 3.

Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Objective:  This study aimed to determine whether specific factors of the built environment related to physical activity and diet are associated with inadequate and excessive gestational weight gain (GWG).

Study Design:  This analysis is based on data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be, a prospective cohort of nulliparous women who were followed from the beginning of their pregnancies through delivery. At each study visit, home addresses were recorded and geocoded. Locations were linked to several built-environment characteristics such as the census tract National Walkability Score (the 2010 Walkability Index) and the number of gyms, parks, and grocery stores within a 3-km radius of residential address. The primary outcome of GWG (calculated as the difference between prepregnancy weight and weight at delivery) was categorized as inadequate, appropriate, or excessive based on weight gained per week of gestation. Multinomial regression (generalized logit) models evaluated the relationship between each factor in the built environment and excessive or inadequate GWG.

Results:  Of the 8,182 women in the analytic sample, 5,819 (71.1%) had excessive GWG, 1,426 (17.4%) had appropriate GWG, and 937 (11.5%) had inadequate GWG. For the majority of variables examined, built environments more conducive to physical activity and healthful food availability were associated with a lower odds of excessive or inadequate GWG category. For example, a higher number of gyms or parks within 3 km of a participant's residential address was associated with lower odds of having excessive (gyms: adjusted odds ratio [aOR] = 0.93 [0.89-0.96], parks: 0.94 [0.90-0.98]) or inadequate GWG (gyms: 0.91 [0.86-0.96]; parks: 0.91 [0.86-0.97]). Similarly, a higher number of grocery stores was associated with lower odds of having excessive GWG (0.94 [0.91-0.97]).

Conclusion:  Among a diverse population of nulliparous women, multiple aspects of the built environment are associated with excessive and inadequate GWG.

Key Points: · There are little data on the association between the built environment and pregnancy outcomes.. · Multiple aspects of the built environment are associated with excessive and inadequate GWG.. · These results suggest the role that neighborhood investment may play in improving pregnancy outcomes..
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http://dx.doi.org/10.1055/s-0041-1730363DOI Listing
June 2021

Racial and Ethnic Disparities in Adverse Perinatal Outcomes at Term.

Am J Perinatol 2021 May 31. Epub 2021 May 31.

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

Objective:  This study aimed to evaluate whether racial and ethnic disparities in adverse perinatal outcomes exist at term.

Study Design:  We performed a secondary analysis of a multicenter observational study of 115,502 pregnant patients and their neonates (2008-2011). Singleton, nonanomalous pregnancies delivered from 37 to 41 weeks were included. Race and ethnicity were abstracted from the medical record and categorized as non-Hispanic White (White; referent), non-Hispanic Black (Black), non-Hispanic Asian (Asian), or Hispanic. The primary outcome was an adverse perinatal composite defined as perinatal death, Apgar score < 4 at 5 minutes, ventilator support, hypoxic-ischemic encephalopathy, subgaleal hemorrhage, skeletal fracture, infant stay greater than maternal stay (by ≥ 3 days), brachial plexus palsy, or facial nerve palsy.

Results:  Of the 72,117 patients included, 48% were White, 20% Black, 5% Asian, and 26% Hispanic. The unadjusted risk of the primary outcome was highest for neonates of Black patients (3.1%, unadjusted relative risk [uRR] = 1.16, 95% confidence interval [CI]: 1.04-1.30), lowest for neonates of Hispanic patients (2.1%, uRR = 0.80, 95% CI: 0.71-0.89), and no different for neonates of Asian (2.6%), compared with those of White patients (2.7%). In the adjusted model including age, body mass index (BMI), smoking, obstetric history, and high-risk pregnancy, differences in risk for the primary outcome were no longer observed for neonates of Black (adjusted relative risk [aRR] = 1.06, 95% CI: 0.94-1.19) and Hispanic (aRR = 0.92, 95% CI: 0.81-1.04) patients. Adding insurance to the model lowered the risk for both groups (aRR = 0.85, 95% CI: 0.75-0.96 for Black; aRR = 0.68, 95% CI: 0.59-0.78 for Hispanic).

Conclusion:  Although neonates of Black patients have the highest frequency of adverse perinatal outcomes at term, after adjustment for sociodemographic factors, this higher risk is no longer observed, suggesting the importance of developing strategies that address social determinants of health to lessen extant health disparities.

Key Points: · Term neonates of Black patients have the highest crude frequency of adverse perinatal outcomes.. · After adjustment for confounders, higher risk for neonates of Black patients is no longer observed.. · Disparities in outcomes are strongly related to insurance status..
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http://dx.doi.org/10.1055/s-0041-1730348DOI Listing
May 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

Prediction of vaginal birth after cesarean delivery in term gestations: a calculator without race and ethnicity.

Am J Obstet Gynecol 2021 May 24. Epub 2021 May 24.

Department of Obstetrics and Gynecology, Ohio State University, Columbus, OH.

Background: Investigators have attempted to derive tools that could provide clinicians with an easily obtainable estimate of the chance of vaginal birth after cesarean delivery for those who undertake trial of labor after cesarean delivery. One tool that has been validated externally was derived from data from the Maternal-Fetal Medicine Units Cesarean Registry. However, concern has been raised that this tool includes the socially constructed variables of race and ethnicity.

Objective: This study aimed to develop an accurate tool to predict vaginal birth after cesarean delivery, using data easily obtainable early in pregnancy, without the inclusion of race and ethnicity.

Study Design: This was a secondary analysis of the Cesarean Registry of the Maternal-Fetal Medicine Units Network. The approach to the current analysis is similar to that of the analysis in which the previous vaginal birth after cesarean delivery prediction tool was derived. Specifically, individuals were included in this analysis if they were delivered on or after 37 0/7 weeks' gestation with a live singleton cephalic fetus at the time of labor and delivery admission, had a trial of labor after cesarean delivery, and had a history of 1 previous low-transverse cesarean delivery. Information was only considered for inclusion in the model if it was ascertainable at an initial prenatal visit. Model selection and internal validation were performed using a cross-validation procedure, with the dataset randomly and equally divided into a training set and a test set. The training set was used to identify factors associated with vaginal birth after cesarean delivery and build the logistic regression predictive model using stepwise backward elimination. A final model was generated that included all variables found to be significant (P<.05). The accuracy of the model to predict vaginal birth after cesarean delivery was assessed using the concordance index. The independent test set was used to estimate classification errors and validate the model that had been developed from the training set, and calibration was assessed. The final model was then applied to the overall analytical population.

Results: Of the 11,687 individuals who met the inclusion criteria for this secondary analysis, 8636 (74%) experienced vaginal birth after cesarean delivery. The backward elimination variable selection yielded a model from the training set that included maternal age, prepregnancy weight, height, indication for previous cesarean delivery, obstetrical history, and chronic hypertension. Vaginal birth after cesarean delivery was significantly more likely for women who were taller and had a previous vaginal birth, particularly if that vaginal birth had occurred after a previous cesarean delivery. Conversely, vaginal birth after cesarean delivery was significantly less likely for women whose age was older, whose weight was heavier, whose indication for previous cesarean delivery was arrest of dilation or descent, and who had a history of medication-treated chronic hypertension. The model had excellent calibration between predicted and empirical probabilities and, when applied to the overall analytical population, an area under the receiver operating characteristic curve of 0.75 (95% confidence interval, 0.74-0.77), which is similar to the area under the receiver operating characteristic curve of the previous model (0.75) that included race and ethnicity.

Conclusion: We successfully derived an accurate model (available at https://mfmunetwork.bsc.gwu.edu/web/mfmunetwork/vaginal-birth-after-cesarean-calculator), which did not include race or ethnicity, for the estimation of the probability of vaginal birth after cesarean delivery.
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http://dx.doi.org/10.1016/j.ajog.2021.05.021DOI Listing
May 2021

In Reply.

Obstet Gynecol 2021 06;137(6):1126-1127

University of Texas Medical Branch at Galveston, Galveston, Texas.

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http://dx.doi.org/10.1097/AOG.0000000000004417DOI Listing
June 2021

COVID-19 Vaccine Considerations during Pregnancy and Lactation.

Am J Perinatol 2021 05 1;38(6):523-528. Epub 2021 May 1.

Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.

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http://dx.doi.org/10.1055/s-0041-1726390DOI Listing
May 2021

Associations of the Neighborhood Built Environment With Physical Activity Across Pregnancy.

J Phys Act Health 2021 Apr 15;18(5):541-547. Epub 2021 Apr 15.

Background: Several features of the neighborhood built environment have been shown to promote leisure-time physical activity (PA) in the general population, but few studies have examined its impact on PA during pregnancy.

Methods: Data were extracted from 8362 Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be cohort participants (2010-2013). Residential address information was linked to 3 built environment characteristics: number of gyms and recreation areas within a 3-km radius of residence and census block level walkability. Self-reported leisure-time PA was measured in each trimester and dichotomized as meeting PA guidelines or not. Relative risks for cross-sectional associations between neighborhood characteristics and meeting PA guidelines were estimated using Poisson regression.

Results: More gyms and recreation areas were each associated with a greater chance of meeting PA guidelines in models adjusted for sociodemographic characteristics and preexisting conditions. Associations were strongest in the third trimester where each doubling in counts of gyms and recreation areas was associated with 10% (95% confidence interval, 1.07-1.13) and 8% (95% confidence interval, 1.03-1.12), respectively, greater likelihood of meeting PA guidelines. Associations were similar though weaker for walkability.

Conclusions: Results from a large, multisite cohort suggest that these built environment characteristics have similar PA-promoting benefits in pregnant women as seen in more general populations.
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http://dx.doi.org/10.1123/jpah.2020-0510DOI Listing
April 2021

Differences in obstetrical care and outcomes associated with the proportion of the obstetrician's shift completed.

Am J Obstet Gynecol 2021 Apr 2. Epub 2021 Apr 2.

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

Background: Understanding and improving obstetrical quality and safety is an important goal of professional societies, and many interventions such as checklists, safety bundles, educational interventions, or other culture changes have been implemented to improve the quality of care provided to obstetrical patients. Although many factors contribute to delivery decisions, a reduced workload has addressed how provider issues such as fatigue or behaviors surrounding impending shift changes may influence the delivery mode and outcomes.

Objective: The objective was to assess whether intrapartum obstetrical interventions and adverse outcomes differ based on the temporal proximity of the delivery to the attending's shift change.

Study Design: This was a secondary analysis from a multicenter obstetrical cohort in which all patients with cephalic, singleton gestations who attempted vaginal birth were eligible for inclusion. The primary exposure used to quantify the relationship between the proximity of the provider to their shift change and a delivery intervention was the ratio of time from the most recent attending shift change to vaginal delivery or decision for cesarean delivery to the total length of the shift. Ratios were used to represent the proportion of time completed in the shift by normalizing for varying shift lengths. A sensitivity analysis restricted to patients who were delivered by physicians working 12-hour shifts was performed. Outcomes chosen included cesarean delivery, episiotomy, third- or fourth-degree perineal laceration, 5-minute Apgar score of <4, and neonatal intensive care unit admission. Chi-squared tests were used to evaluate outcomes based on the proportion of the attending's shift completed. Adjusted and unadjusted logistic models fitting a cubic spline (when indicated) were used to determine whether the frequency of outcomes throughout the shift occurred in a statistically significant, nonlinear pattern RESULTS: Of the 82,851 patients eligible for inclusion, 47,262 (57%) had ratio data available and constituted the analyzable sample. Deliveries were evenly distributed throughout shifts, with 50.6% taking place in the first half of shifts. There were no statistically significant differences in the frequency of cesarean delivery, episiotomy, third- or fourth-degree perineal lacerations, or 5-minute Apgar scores of <4 based on the proportion of the shift completed. The findings were unchanged when evaluated with a cubic spline in unadjusted and adjusted logistic models. Sensitivity analyses performed on the 22.2% of patients who were delivered by a physician completing a 12-hour shift showed similar findings. There was a small increase in the frequency of neonatal intensive care unit admissions with a greater proportion of the shift completed (adjusted P=.009), but the findings did not persist in the sensitivity analysis.

Conclusion: Clinically significant differences in obstetrical interventions and outcomes do not seem to exist based on the temporal proximity to the attending physician's shift change. Future work should attempt to directly study unit culture and provider fatigue to further investigate opportunities to improve obstetrical quality of care, and additional studies are needed to corroborate these findings in community settings.
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http://dx.doi.org/10.1016/j.ajog.2021.03.033DOI Listing
April 2021

Maternal Opioid Exposure Culminates in Perturbed Murine Neurodevelopment and Hyperactive Phenotype in Adolescence.

Neuroscience 2021 05 31;463:272-287. Epub 2021 Mar 31.

Department of Neuroscience, Cell Biology, and Anatomy, University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555, United States; Center for Addiction Research, University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555, United States. Electronic address:

Opioid use by women during pregnancy has risen dramatically since 2004, accompanied by a striking increase in the prevalence of neonatal opioid withdrawal syndrome (NOWS) and other long-term neurological deficits. However, the mechanisms underlying the impact of prenatal opioid exposure on fetal neurodevelopment are largely unknown. To translate from the clinical presentation, we developed a novel mouse model to study the neurodevelopmental consequences of maternal opioid use and management. Female mice were treated with oxycodone (OXY) before mating to mimic opioid use disorder (OUD) in humans. Following pregnancy confirmation, dams were switched to buprenorphine (BUP) via oral administration, simulating medication management of OUD (MOUD) in pregnant women. Here, we document critical changes in fetal brain development including reduced cortical thickness, altered corticogenesis, and ventriculomegaly in embryos from dams that were treated with opioids before and throughout pregnancy. Maternal care giving behavior was slightly altered without affecting gross growth of offspring. However, adolescent offspring exposed to maternal opioid use during pregnancy exhibited hyperactivity in late adolescence. Remarkably, we also show increased generation of dopaminergic neurons within the ventral tegmental area (VTA) of mice exposed to prenatal opioids. These data provide critical evidence of teratogenic effects of opioid use during pregnancy and suggest a causal relationship between maternal opioid use and neurodevelopmental/behavioral anomalies in adolescence.
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http://dx.doi.org/10.1016/j.neuroscience.2021.03.014DOI Listing
May 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 Feb 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

Quality criteria for randomized controlled studies: obstetrical journal guidelines.

Am J Obstet Gynecol MFM 2021 05 16;3(3):100334. Epub 2021 Feb 16.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA (Dr Berghella). Electronic address:

Background: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later.

Objective: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals.

Study Design: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals.

Results: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals.

Conclusion: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324065PMC
May 2021

Disease Severity and Perinatal Outcomes of Pregnant Patients With Coronavirus Disease 2019 (COVID-19).

Obstet Gynecol 2021 04;137(4):571-580

Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, University of Texas Medical Branch at Galveston, Galveston, Texas, Northwestern University, Chicago, Illinois, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Columbia University, New York, New York, University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, Texas, University of Pennsylvania, Philadelphia, Pennsylvania, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio, The Ohio State University, Columbus, Ohio, University of Pittsburgh, Pittsburgh, Pennsylvania, and University of Texas at Austin, Austin, Texas; 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 describe coronavirus disease 2019 (COVID-19) severity in pregnant patients and evaluate the association between disease severity and perinatal outcomes.

Methods: We conducted an observational cohort study of all pregnant patients with a singleton gestation and a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who delivered at 1 of 33 U.S. hospitals in 14 states from March 1 to July 31, 2020. Disease severity was classified by National Institutes of Health criteria. Maternal, fetal, and neonatal outcomes were abstracted by centrally trained and certified perinatal research staff. We evaluated trends in maternal characteristics and outcomes across COVID-19 severity classes and associations between severity and outcomes by multivariable modeling.

Results: A total of 1,219 patients were included: 47% asymptomatic, 27% mild, 14% moderate, 8% severe, 4% critical. Overall, 53% were Hispanic; there was no trend in race-ethnicity distribution by disease severity. Those with more severe illness had older mean age, higher median body mass index, and pre-existing medical comorbidities. Four maternal deaths (0.3%) were attributed to COVID-19. Frequency of perinatal death or a positive neonatal SARS-CoV-2 test result did not differ by severity. Adverse perinatal outcomes were more frequent among patients with more severe illness, including 6% (95% CI 2-11%) incidence of venous thromboembolism among those with severe-critical illness compared with 0.2% in mild-moderate and 0% in asymptomatic (P<.001 for trend across severity). In adjusted analyses, severe-critical COVID-19 was associated with increased risk of cesarean birth (59.6% vs 34.0%, adjusted relative risk [aRR] 1.57, 95% CI 1.30-1.90), hypertensive disorders of pregnancy (40.4% vs 18.8%, aRR 1.61, 95% CI 1.18-2.20), and preterm birth (41.8% vs 11.9%, aRR 3.53, 95% CI 2.42-5.14) compared with asymptomatic patients. Mild-moderate COVID-19 was not associated with adverse perinatal outcomes compared with asymptomatic patients.

Conclusion: Compared with pregnant patients with SARS-CoV-2 infection without symptoms, those with severe-critical COVID-19, but not those with mild-moderate COVID-19, were at increased risk of perinatal complications.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984765PMC
April 2021

Clinical Stratification of Pregnant COVID-19 Patients based on Severity: A Single Academic Center Experience.

Am J Perinatol 2021 04 6;38(5):515-522. Epub 2021 Feb 6.

Division of Maternal-Fetal Medicine, The University of Texas Medical Branch, Galveston, Texas.

Objective: This study aimed to describe baseline characteristics of a cohort of pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and determine if these correlate with disease severity and perinatal outcomes.

Study Design: This was a retrospective cohort trial conducted at the University of Texas Medical Branch Galveston, Texas. All pregnant women presented to our medical center, who were screened and tested positive for SARS-CoV-2 virus, were included. We stratified our study population in three groups: asymptomatic, symptomatic not requiring oxygen therapy, and patients requiring oxygen support to maintain oxygen saturation >94%. Relevant population characteristics, laboratory data, and maternal and neonatal outcomes were abstracted. A -value <0.05 was considered statistically significant.

Results: Between March and July 2020, 91 women tested positive for SARS-CoV-2 upon admission to our labor and delivery unit. Among these, 61.5% were asymptomatic, 34.1% were symptomatic, and 4.4% required oxygen support. Our population was mainly Hispanic (80.2%), multiparous (76.9%), obese (70.3%), and with a median age of 27 years. Median gestational age at symptom onset or diagnosis was 36 weeks. Significant differences were found between gestational age and disease severity. Maternal characteristics including age, body mass index (BMI), and presence of comorbid conditions did not appear to influence severity of SARS-CoV-2 infection. Significant laboratory findings associated with increasing disease severity included decreasing hemoglobin and white blood cell count, lymphopenia, and increasing levels of inflammatory markers including CRP, ferritin, and procalcitonin. Maternal and neonatal outcomes did not differ among groups. No SARS-CoV-2 was detected by polymerase chain reaction testing in neonates of mothers with COVID-19.

Conclusion: Pregnant patients with COVID-19 infection are predominantly asymptomatic. Patients appear to be at increased risk for more severe infection requiring oxygen support later in pregnancy.

Key Points: · The majority of pregnant patients with COVID-19 are asymptomatic and <1 in 20 require oxygen support.. · Women in the later stages of pregnancy may be at increased risk for severe infection.. · Anemia, leukopenia, CRP, ferritin, and procalcitonin are associated with increasing severity..
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April 2021

In Reply.

Obstet Gynecol 2021 02;137(2):380-381

Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, and the Division of Surgical Critical Care, Department of Anesthesiology, the University of Texas Medical Branch at Galveston, Galveston, Texas.

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February 2021

In Reply.

Obstet Gynecol 2021 02;137(2):373-374

Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.

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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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February 2021

The association between personal weight gain goals, provider recommendations, and appropriate gestational weight gain.

Am J Obstet Gynecol MFM 2020 11 22;2(4):100231. Epub 2020 Sep 22.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University, Evanston, IL.

Background: Nearly half of all women exceed the 2009 Institute of Medicine guidelines for gestational weight gain. Excess gestational weight gain is associated with adverse pregnancy outcomes.

Objective: Our objective was to determine whether having a personal gestational weight gain goal consistent with the Institute of Medicine's recommendations for appropriate gestational weight gain and whether having a discussion with one's obstetrical provider regarding that goal were associated with appropriate gestational weight gain.

Study Design: This is a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be study, a prospective cohort study of nulliparous women. We asked women at their first study visit (between 6 and 13 weeks' gestation) whether they had a gestational weight gain goal and what that goal was. Furthermore, we asked whether their provider discussed a gestational weight gain goal and what that goal was. We classified personal and provider-recommended gestational weight gain goals as consistent or inconsistent with the Institute of Medicine guidelines, taking into account a woman's initial body mass index category (underweight, normal weight, overweight, and obese). We included women with live singleton term deliveries (between 37 and 43 weeks' gestation) in this analysis. We classified the primary outcome, which was gestational weight gain (defined as the difference between first visit weight and final weight before delivery), as inadequate, appropriate, or excessive, based on the Institute of Medicine guidelines and initial body mass index category. We used Student t, Wilcoxon rank-sum, and chi-square tests for bivariable analyses, and multinomial logistic regression was performed to control for confounding variables.

Results: Of 6727 eligible women, 3799 (56.5% of all eligible women) stated they had a gestational weight gain goal. Of the 3799 women with a stated goal, 2589 (38.5% of all women) had a goal consistent with the Institute of Medicine's recommendations. In addition, of the 6727 eligible women, 2188 (32.5%) reported that they discussed gestational weight gain with their provider, and 1548 of these (23.0% of all women) recalled that their provider gave a gestational weight gain goal in accordance with the Institute of Medicine guidelines. Although having any gestational weight gain goal was not associated with appropriate gestational weight gain, having a gestational weight gain goal that was consistent with the Institute of Medicine's recommendations was associated with a reduced risk of excessive (adjusted relative risk ratio, 0.77; 95% confidence interval, 0.64-0.92) and inadequate weight gain (adjusted relative risk ratio, 0.66; 95% confidence interval, 0.53-0.82). Conversely, discussing gestational weight gain goals with a provider was not associated with either inadequate or excessive gestational weight gain even if the provider's recommendations for gestational weight gain were consistent with the guidelines.

Conclusion: Nulliparas who delivered singleton pregnancies at term who had a personal gestational weight gain goal consistent with the Institute of Medicine's recommendations were less likely to have excessive or inadequate gestational weight gain. Further study is required to evaluate the most effective way to communicate this information to patients.
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November 2020

Performance of a proteomic preterm delivery predictor in a large independent prospective cohort.

Am J Obstet Gynecol MFM 2020 08 17;2(3):100140. Epub 2020 May 17.

Sera Prognostics, Salt Lake City, UT. Electronic address:

Background: Preterm birth remains a common and devastating complication of pregnancy. There remains a need for effective and accurate screening methods for preterm birth. Using a proteomic approach, we previously discovered and validated (Proteomic Assessment of Preterm Risk study, NCT01371019) a preterm birth predictor comprising a ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin.

Objective: To determine the performance of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin to predict both spontaneous and medically indicated very preterm births, in an independent cohort distinct from the one in which it was developed.

Study Design: This was a prospective observational study (Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor, NCT02787213) at 18 sites in the United States. Women had blood drawn at 17 to 21 weeks' gestation. For confirmation, we planned to analyze a randomly selected subgroup of women having blood drawn between 19 and 20 weeks' gestation, with the results of the remaining study participants blinded for future validation studies. Serum from participants was analyzed by mass spectrometry. Neonatal morbidity and mortality were analyzed using a composite score by a method from the PREGNANT trial (NCT00615550, Hassan et al). Scores of 0-3 reflect increasing numbers of morbidities or length of neonatal intensive care unit stay, and 4 represents perinatal mortality.

Results: A total of 5011 women were enrolled, with 847 included in this planned substudy analysis. There were 9 preterm birth cases at <32 weeks' gestation and 838 noncases at ≥32 weeks' gestation; 21 of 847 infants had neonatal composite morbidity and mortality index scores of ≥3, and 4 of 21 had a score of 4. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was substantially higher in both preterm births at <32 weeks' gestation and there were more severe neonatal outcomes. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was significantly predictive of birth at <32 weeks' gestation (area under the receiver operating characteristic curve, 0.71; 95% confidence interval, 0.55-0.87; P=.016). Stratification by body mass index, optimized in the previous validation study (22
Conclusion: We confirmed in an independent cohort the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio as a predictor of very preterm birth, with additional prediction of increased length of neonatal hospital stay and increased severity of adverse neonatal outcomes. Potential uses of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin predictor may be to risk stratify patients for implementation of preterm birth preventive strategies and direct patients to appropriate levels of care.
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August 2020

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://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757682PMC
November 2019

Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.

Obstet Gynecol 2021 Jan;137(1):139-145

Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.

Objective: To test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection.

Methods: In an open-label noninferiority randomized trial, pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced) were randomly assigned to balloon catheter that was placed either digitally or using a sterile speculum. The primary outcome was a composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife). Prespecified secondary outcomes included outcomes in the primary composite, cesarean delivery rates, and maternal and neonatal outcomes. A patient satisfaction survey was also obtained. On the basis of a noninferiority margin of 10% and an expected primary outcome frequency of 10%, a sample size of 372 women was needed (90% power to confirm noninferiority with 90% protocol adherence).

Results: From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum). Baseline characteristics were similar between groups. The composite maternal infection rate was not different between groups (digital placement arm: 15.7% vs speculum arm: 12.8%), with an absolute difference with respect to the sterile speculum arm of 2.8% (95% CI -4.3 to 9.9%), indicating noninferiority for the prespecified margin. Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm. Maternal and neonatal adverse events were not different between groups. Irrespective of method of placement, women were equally satisfied with the explanation of the method before placement, anxiety regarding the procedure, and pain during placement. More women in the sterile speculum group would choose the digital placement method for the subsequent pregnancy (37.6% vs 25.7%; P=.02.).

Conclusion: Digital placement of a balloon catheter for preinduction cervical ripening is noninferior to the sterile speculum method, in terms of maternal infection. Women in the sterile speculum group more frequently required a second round of the mechanical dilator. The blind digital approach is a reasonable option for balloon placement for cervical ripening.

Clinical Trial Registration: ClinicalTrials.gov, NCT03450408.
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January 2021

Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial.

Am J Perinatol 2020 Dec 2. Epub 2020 Dec 2.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.

Objective:  This study aimed to evaluate the effect of a novel antimicrobial dressing on patient satisfaction and health-related quality of life (HRQoL) following a cesarean delivery.

Study Design:   This was an open-label, single-center, two-arm randomized controlled trial. This study was done at the tertiary center, maternal unit, Galveston, TX. Pregnant women with body mass indices ≥35 kg/m2 were screened for eligibility. Women were randomized to ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing (STANDARD). Primary outcome was patient satisfaction and HRQoL using validated questionnaires. Secondary outcomes were provider satisfaction, surgical site infection (SSI) rates, and wound complications.

Results:  In total, 160 women were randomized. Population characteristics were not significant among groups. RELIATECT dressing group had an overall higher score of satisfaction and HRQoL compared with STANDARD group. Women in the RELIATECT group reported less incision odor and incisional pain. Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep. Providers reported that the RELIATECT dressing allowed better assessment of the surgical incision site, allowed patients to shower early, and did observe less wound dressing leakage. No differences were found in other secondary end points.

Conclusion:  Postcesarean RELIATECT dressing for wound care in pregnant women with obesity had better patient and provider satisfaction as well as better HRQoL scores. Further, level 1 evidence is needed to assess its impact on SSI rates and wound complication, as this trial was not powered to accomplish this goal.

Key Points: · This study was conducted to evaluate RELIATECT on patient satisfaction and HRQoL following a cesarean.. · Post-cesarean RELIATECT dressing for wound care had better HRQoL and patient and provider satisfaction scores.. · This is the first randomized controlled trial evaluating RELIATECT dressing in obese pregnant women undergoing cesarean section..
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December 2020

The Golden Hour: Early Interventions for Medical Emergencies during Pregnancy.

Am J Perinatol 2020 Nov 26. Epub 2020 Nov 26.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.

Maternal mortality has increased in the last decades in the United States as a result of increased prevalence of coexisting medical diseases such as hypertension, diabetes, and both acquired and congenital heart diseases. Obstetricians and maternal-fetal medicine physicians should have the basic medical knowledge to initiate appropriate diagnostic and early therapeutic interventions since they may be the only provider available at the time of presentation. The goal of this article is not to extensively discuss the management of complex medical diseases during pregnancy, rather we provide a concise review of key early medical interventions that will likely result in improved clinical outcomes. KEY POINTS: · Obstetricians and maternal-fetal medicine physicians must be familiar with initial basic management of common medical emergencies.. · Management of these complex cases is ideally multidisciplinary.. · Residency/fellowship programs should include common disease management to improve maternal outcomes..
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November 2020

Proteinuria in pregnancy: much ado about nothing.

Authors:
George R Saade

Am J Obstet Gynecol 2021 04 16;224(4):421. Epub 2020 Nov 16.

Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, The University of Texas Medical Branch at Galveston, 301 University Blvd, Galveston, TX 77555-0587. Electronic address:

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April 2021
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