Publications by authors named "Dwight J Rouse"

332 Publications

First or second trimester SARS-CoV-2 infection and subsequent pregnancy outcomes.

Am J Obstet Gynecol 2022 Aug 12. Epub 2022 Aug 12.

University of Texas at Austin, Austin, TX.

Background: SARS-CoV2 infection during pregnancy is associated with adverse pregnancy outcomes including fetal death and preterm birth. It is not known whether that risk occurs only during the time of acute infection or whether risk persists later in pregnancy.

Objective: The goal of this analysis was to evaluate whether the risk of SARS-CoV-2 infection during pregnancy persists after acute maternal illness.

Study Design: A retrospective cohort study of pregnant patients with and without SARS-CoV2 infection delivering at 17 hospitals in the United States between March and December 2020. Patients experiencing a SARS-CoV-2 positive test at or prior to 28 weeks' gestation with a subsequent delivery hospitalization were compared with those without a positive SAR-CoV-2 test at the same hospitals with randomly selected delivery days during the same period. Deliveries occurring <20 weeks' gestation in both groups were excluded. Study outcomes included fetal or neonatal death, preterm birth less than 37 weeks' gestation and less than 34 weeks' gestation, hypertensive disorders of pregnancy, any major congenital malformation, and size for gestational age less than 5 or 10 percentiles at birth based on published standards. Hypertensive disorders of pregnancy that were collected included hypertensive disorders of pregnancy and preeclampsia with severe features, both overall and with delivery <37 weeks' gestation.

Results: Of 2,326 patients who tested positive for SARS-CoV-2 during pregnancy and were at least 20 weeks' gestation at delivery from March through December 2020, 402 patients (delivering 414 fetuses/neonates) were SARS-CoV-2 positive before 28 weeks' gestation and prior to their admission for delivery; they were compared to 11,705 patients without a positive SARS-CoV-2 test. In adjusted analyses, those with SARS-CoV-2 prior to 28 weeks' had a subsequent increased risk of fetal/neonatal death [2·9% vs 1·5%, adjusted relative risk (aRR) 1·97, 95% confidence interval (CI),1·01 - 3·85], preterm birth <37 weeks' (19·6% vs 13·8%, aRR, 1·29; 95%CI, 1·02 - 1·63) and hypertensive disorders of pregnancy with delivery less than 37 weeks' gestation (7·2% vs 4·1%, aRR 1·74, 95% CI 1·19-2·55). There were no significant differences in the rates of preterm birth <34 weeks', any major congenital malformation, size for gestational age less than the 5 or 10 percentiles. There were also no significant differences in the rate of gestational hypertension overall or in preeclampsia with severe features.

Conclusion: There is a modest increase in risk of adverse pregnancy outcomes subsequent to SARS-CoV-2 infection.
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http://dx.doi.org/10.1016/j.ajog.2022.08.009DOI Listing
August 2022

Response to Letter.

Obstet Gynecol 2022 Aug;140(2):342-343

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, Rhode Island.

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http://dx.doi.org/10.1097/AOG.0000000000004882DOI Listing
August 2022

Response to Letter.

Obstet Gynecol 2022 Aug;140(2):340-341

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, Rhode Island.

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http://dx.doi.org/10.1097/AOG.0000000000004880DOI Listing
August 2022

The association of race and ethnicity with severe maternal morbidity among individuals diagnosed with hypertensive disorders of pregnancy.

Am J Perinatol 2022 Jun 28. Epub 2022 Jun 28.

Obstetrics & Gynecology, University of Texas Health Sciences Center at Houston, Houston, United States.

Objective: To examine racial disparities in severe maternal morbidity in patients with hypertensive disorder of pregnancy (HDP).

Study Design: Secondary analysis of an observational study of 115,502 patients who had a live birth at ≥ 20 weeks in 25 hospitals in the US, 2008-2011. Only patients with HDP were included in this analysis. Race and ethnicity were categorized as non-Hispanic White (NHW), non-Hispanic Black (NHB) and Hispanic. Associations were estimated between race and ethnicity and the primary outcome of severe maternal morbidity, defined as any of the following: blood transfusion ≥4 units, unexpected surgical procedure, need for a ventilator ≥ 12 hours, intensive care unit (ICU) admission, or failure of ≥ 1 organ system, were estimated by unadjusted logistic and multivariable backward logistic regressions. Multivariable models were run classifying HDP into 3 levels: 1) gestational hypertension; 2) preeclampsia (mild, severe or superimposed); and 3) eclampsia or HELLP.

Results: A total of 9,612 individuals with HDP were included. The frequency of the primary outcome, composite severe maternal morbidity, was higher in NHB patients compared with that in NHW or Hispanic patients (11.8% vs. 4.5% in NHW and 4.8% in Hispanic, p<0.001). This was driven by a higher frequency of blood transfusions and ICU admissions among NHB individuals. After adjusting for sociodemographic and clinical factors, hospital site, and the severity of HDP, the odds ratios of composite severe maternal morbidity did not differ between the groups (adjusted OR 1.26, 95% CI 0.95, 1.67 for NHB and adjusted OR 1.29, 95% CI 0.94, 1.77 for Hispanic, compared to NHW patients).

Conclusion: NHB patients with HDP had higher rates of the composite maternal morbidity compared with NHW, driven mainly by higher frequencies of blood transfusions and ICU admissions. However, once severity and other confounding factors were taken into account, the differences did not persist.
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http://dx.doi.org/10.1055/a-1886-5404DOI Listing
June 2022

ASSOCIATION OF MATERNAL BODY MASS INDEX AND MATERNAL MORBIDITY AND MORTALITY.

Am J Perinatol 2022 Jun 16. Epub 2022 Jun 16.

Oregon Health Sciences University, Portland, Portland, United States.

Objective: To assess the association of maternal BMI with a composite of severe maternal outcomes.

Study Design: Secondary analysis of a cohort of deliveries on randomly selected days at 25 hospitals from 2008-2011. Data on comorbid conditions, intrapartum events, and postpartum course were collected. The reference group (REF, BMI 18.5-29.9), obese (OB, BMI 30-39.9), morbidly obese (MO, BMI 40-49.9) and super morbidly obese (SMO, BMI  50) women were compared. The composite of severe maternal outcomes was defined as death, ICU admission, ventilator use, DVT/PE, sepsis, hemorrhage, DIC, unplanned operative procedure, or stroke. Patients in the REF group were matched 1:1 with those in all other obesity groups based on propensity score using the baseline characteristics of age, race-ethnicity, previous cesarean, pre-existing diabetes, chronic hypertension, parity, cigarette use, and insurance status. Multivariable Poisson regression was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI) for the association between BMI and the composite outcome. Because cesarean delivery may be in the causal pathway between obesity and adverse maternal outcomes, models were then adjusted for mode of delivery to evaluate potential mediation.

Results: A total of 52,162 pregnant patients are included in the analysis. Risk of composite maternal outcomes was increased for SMO compared with REF, but not for OB and MO [OB aRR 1.06 95%CI (0.99-1.14); MO aRR 1.10 (95%CI 0.97-1.25); SMO aRR 1.32 95%CI (1.02-1.70)]. However, in the mediation analysis, cesarean appears to mediate 46% (95%CI 31% - 50%) of the risk of severe morbidity for SMO compared with REF.

Conclusion: Super morbid obesity is significantly associated with increased serious maternal morbidity and mortality; however, cesarean appears to mediate this association. Obesity and morbid obesity are not associated with maternal morbidity and mortality.
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http://dx.doi.org/10.1055/a-1877-8918DOI Listing
June 2022

Predicting progression from gestational diabetes to impaired glucose tolerance using peri-delivery data: an observational study.

Am J Perinatol 2022 Jun 16. Epub 2022 Jun 16.

Obstetrics and Gynecology, Brown University, Providence, United States.

Objective: To develop a predictive model to identify persons with recent gestational diabetes (GDM) most likely to progress to impaired glucose tolerance postpartum.

Study Design: We conducted an observational study among persons with GDM in their most recent pregnancy, defined by Carpenter-Coustan criteria. Participants were followed from delivery through 1-year postpartum. We used lasso regression with k-fold cross validation to develop a multivariable model to predict progression to impaired glucose tolerance, defined as HbA1c ≥ 5.7%, at 1 year postpartum. Predictive ability was assessed by the area under the curve (AUC), sensitivity, specificity, positive and negative predictive values.

Results: Of 203 participants, 71(35%) had impaired glucose tolerance at 1 year postpartum. The final model had an AUC of 0.79 (95% CI 0.72, 0.85) and included eight indicators of weight, body mass index, family history of type 2 diabetes, GDM in a prior pregnancy, GDM diagnosis < 24 weeks' gestation, and fasting and 2-hour plasma glucose at 2 days postpartum. A cut-point of ≥ 0.25 predicted probability had sensitivity 80% (95% CI 69, 89), specificity 58% (95% CI 49, 67), PPV 51% (95% CI 41, 61) and NPV 85% (95% CI 76, 91) to identify women with impaired glucose tolerance at 1 year postpartum.

Conclusion: Our predictive model had reasonable ability to predict impaired glucose tolerance around delivery for persons with recent GDM.
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http://dx.doi.org/10.1055/a-1877-9587DOI Listing
June 2022

Differential Gene Expression in Cord Blood of Infants Diagnosed with Cerebral Palsy: a Pilot Analysis of the BEAM Cohort.

Dev Neurosci 2022 Jun 15. Epub 2022 Jun 15.

The Beneficial Effects of Antenatal Magnesium (BEAM) clinical trial was conducted between 1997-2007, and demonstrated a significant reduction in cerebral palsy (CP) in preterm infants who were exposed to peripartum magnesium sulfate (MgSO4). However, the mechanism by which MgSO4 confers neuroprotection remains incompletely understood. Cord blood samples from this study were interrogated during an era when next generation sequencing was not widely accessible and few gene expression differences or biomarkers were identified between treatment groups. Our goal was to use bulk RNA deep sequencing to identify differentially expressed genes comparing the following four groups: newborns who ultimately developed CP treated with MgSO4 or placebo, and controls (newborns who ultimately did not develop CP) treated with MgSO4 or placebo. Those who died after birth were excluded. We found that MgSO4 upregulated expression of SCN5A only in the control group, with no change in gene expression in cord blood of newborns who ultimately developed CP. Regardless of MgSO4 exposure, expression of NPBWR1 and FTO were upregulated in cord blood of newborns who ultimately developed CP compared with controls. These data support that MgSO4 may not exert its neuroprotective effect through changes in gene expression. Moreover, NPBWR1 and FTO may be useful as biomarkers, and may suggest new mechanistic pathways to pursue in understanding the pathogenesis of CP. The small number of cases ultimately available for this secondary analysis, with male predominance and mild CP phenotype, is a limitation of the study. In addition, differentially expressed genes were not validated by qRT-PCR.
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http://dx.doi.org/10.1159/000525483DOI Listing
June 2022

Comparison of Cesarean Deliveries in a Multicenter U.S. Cohort Using the 10-Group Classification System.

Am J Perinatol 2022 Jun 3. Epub 2022 Jun 3.

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

Objective:  We sought to (1) use the Robson 10-Group Classification System (TGCS), which classifies deliveries into 10 mutually exclusive groups, to characterize the groups that are primary contributors to cesarean delivery frequencies, (2) describe inter-hospital variations in cesarean delivery frequencies, and (3) evaluate the contribution of patient characteristics by TGCS group to hospital variation in cesarean delivery frequencies.

Study Design:  This was a secondary analysis of an observational cohort of 115,502 deliveries from 25 hospitals between 2008 and 2011. The TGCS was applied to the cohort and each hospital. We identified and compared the TGCS groups with the greatest relative contributions to cohort and hospital cesarean delivery frequencies. We assessed variation in hospital cesarean deliveries attributable to patient characteristics within TGCS groups using hierarchical logistic regression.

Results:  A total of 115,211 patients were classifiable in the TGCS (99.7%). The cohort cesarean delivery frequency was 31.4% (hospital range: 19.1-39.3%). Term singletons in vertex presentation with a prior cesarean delivery (group 5) were the greatest relative contributor to cohort (34.8%) and hospital cesarean delivery frequencies (median: 33.6%; range: 23.8-45.5%). Nulliparous term singletons in vertex (NTSV) presentation (groups 1 [spontaneous labor] and 2 [induced or absent labor]: 28.9%), term singletons in vertex presentation with a prior cesarean delivery (group 5: 34.8%), and preterm singletons in vertex presentation (group 10: 9.8%) contributed to 73.2% of the relative cesarean delivery frequency for the cohort and were correlated with hospital cesarean delivery frequencies (Spearman's rho = 0.96). Differences in patient characteristics accounted for 34.1% of hospital-level cesarean delivery variation in group 2.

Conclusion:  The TGCS highlights the contribution of NTSV presentation to cesarean delivery frequencies and the impact of patient characteristics on hospital-level variation in cesarean deliveries among nulliparous patients with induced or absent labor.

Key Points: · We report on the cesarean delivery frequencies in a multicenter U.S.

Cohort: . · NTSV gestations (groups 1 and 2) are a primary driver of cesarean deliveries.. · Patient characteristics contributed most to hospital variation in cesarean deliveries in group 2..
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http://dx.doi.org/10.1055/s-0042-1748527DOI Listing
June 2022

The effects of betamethasone on the amplitude integrated EEG of infants born at 34- or 35-weeks gestation.

J Perinatol 2022 May 26. Epub 2022 May 26.

Department of Global and Community Health, George Mason University, Fairfax, VA, USA.

Objective: Assess if maternal betamethasone administration at 34-35 weeks accelerated neonatal amplitude integrated EEG (aEEG) maturation.

Study Design: Nested, observational cohort in 7 centers participating in the Antenatal Late Preterm Steroid randomized trial. Up to 2 aEEGs were obtained in neonates born from 34-35 weeks gestation before 72 h (aEEG 1) and at 5-7 days (aEEG 2) if hospitalized. Personnel and aEEG central readers were masked to the intervention. The primary outcome was maturation reflected by cycle frequency; secondary outcomes were border voltage, span, and discontinuity.

Results: 58 neonates were enrolled (betamethasone, 28, placebo, 30). On aEEG 1, cycle frequency did not differ, but betamethasone exposed infants had a greater lower border voltage and a broader span. On aEEG 2, both groups displayed increases in lower border voltage.

Conclusions: Betamethasone associated changes in lower border voltage support accelerated electrical activity. Further investigation is needed to understand the broader span.
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http://dx.doi.org/10.1038/s41372-022-01415-4DOI Listing
May 2022

Association of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation.

Obstet Gynecol 2022 05 5;139(5):866-876. Epub 2022 Apr 5.

Departments of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, 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, MetroHealth 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, 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 compare health care medical resource utilization in low-risk nulliparous pregnancies according to body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) categories.

Methods: This is a secondary analysis of a multicenter randomized controlled trial of induction of labor between 39 0/7 39 and 4/7 weeks of gestation compared with expectant management in low-risk nulliparous pregnant people, defined as those without standard obstetric indications for delivery at 39 weeks. Body mass index at randomization was categorized into four groups (lower than 25, 25-29, 30-39, and 40 or higher). The primary outcome of this analysis was time spent in the labor and delivery department from admission to delivery. Secondary outcomes included length of stay (LOS) postdelivery, total hospital LOS, and antepartum, intrapartum, and postpartum resource utilization, which were defined a priori. Multivariable generalized linear modeling and logistic regressions were performed, and 99% CIs were calculated.

Results: A total of 6,058 pregnant people were included in the analysis; 640 (10.6%) had BMIs of lower than 25, 2,222 (36.7%) had BMIs between 25 and 29, 2,577 (42.5%) had BMIs of 30-39, and 619 (10.2%) had BMIs of 40 or higher. Time spent in the labor and delivery department increased from 15.1±9.2 hours for people with BMIs of lower than 25 to 23.5±13.6 hours for people with BMIs of 40 or higher, and every 5-unit increase in BMI was associated with an average 9.8% increase in time spent in the labor and delivery department (adjusted estimate per 5-unit increase in BMI 1.10, 99% CI 1.08-1.11). Increasing BMI was not associated with an increase in antepartum resource utilization, except for blood tests and urinalysis. However, increasing BMI was associated with higher odds of intrapartum resource utilization, longer total hospital LOS, and postpartum resource utilization. For example, every 5-unit increase in BMI was associated with an increase of 26.1% in the odds of antibiotic administration, 57.6% in placement of intrauterine pressure catheter, 5.1% in total inpatient LOS, 31.0 in postpartum emergency department visit, and 23.9% in postpartum hospital admission.

Conclusion: Among low-risk nulliparous people, higher BMI was associated with longer time from admission to delivery, total hospital LOS, and more frequent utilization of intrapartum and postpartum resources.

Clinical Trial Registration: ClinicalTrials.gov, NCT01990612.
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http://dx.doi.org/10.1097/AOG.0000000000004753DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9142136PMC
May 2022

Amniocentesis to diagnose congenital cytomegalovirus infection following maternal primary infection.

Am J Obstet Gynecol MFM 2022 07 6;4(4):100641. Epub 2022 May 6.

Washington University in St. Louis, MO (Dr Macones).

Background: Congenital cytomegalovirus infection following maternal primary cytomegalovirus infection affects approximately 0.4% of newborns in the United States but may be hard to diagnose prenatally.

Objective: To evaluate the current sensitivity and specificity of amniocentesis in detecting congenital cytomegalovirus infection.

Study Design: Secondary analysis of a multicenter randomized placebo-controlled trial designed to evaluate whether cytomegalovirus hyperimmune globulin reduces congenital cytomegalovirus infection in neonates of individuals diagnosed with primary cytomegalovirus infection before 24 weeks of gestation. At randomization, subjects had no clinical evidence of fetal infection. Eligible subjects were randomized to monthly infusions of cytomegalovirus hyperimmune globulin or placebo until delivery. Although not required by the trial protocol, amniocentesis following randomization was permitted. The fetuses and neonates were tested for the presence of cytomegalovirus at delivery. Comparisons were made between those with and without amniocentesis and between those with cytomegalovirus-positive and negative results, using chi-square or Fisher exact test for categorical variables and the Wilcoxon rank sum test or t test for continuous variables. A P value of <.05 was considered significant.

Results: From 2012 to 2018, 397 subjects were included, of whom 55 (14%) underwent amniocentesis. Cytomegalovirus results were available for 53 fetuses and neonates. Fourteen amniocenteses were positive (25%). Gestational age at amniocentesis was similar between those with and without cytomegalovirus present, as was the interval between maternal diagnosis and amniocentesis. The prevalence of fetal or neonatal infection was 26% (14/53). The neonates of all 12 subjects with a positive amniocentesis and available results had cytomegalovirus infection confirmed at delivery, as did 2 neonates from the group of 41 subjects with a negative amniocentesis, with a sensitivity of 86% (95% confidence interval, 57-98), specificity of 100% (95% confidence interval, 91-100), positive predictive value of 100% (95% confidence interval, 74-100), and negative predictive value of 95% (95% confidence interval, 83-99). Amniocentesis-positive pregnancies were delivered at an earlier gestational age (37.4 vs 39.6 weeks; P<.001) and had lower birthweights (2583±749 vs 3428±608 g, P=.004) than amniocentesis-negative pregnancies.

Conclusion: Amniocentesis results are an accurate predictor of congenital cytomegalovirus infection.
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http://dx.doi.org/10.1016/j.ajogmf.2022.100641DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9167787PMC
July 2022

Assessment and Interpretation of Small or Underpowered Randomized Clinical Trials.

Clin Obstet Gynecol 2022 06 28;65(2):252-259. Epub 2022 Feb 28.

Division of Maternal Fetal Medicine Alpert Medical School of Brown University, Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island, Providence, Rhode Island.

The randomized controlled trial has long been recognized as the gold standard of research designs. As small or underpowered trials have become increasingly common in obstetrics and gynecology, it is essential to appraise the trial design and results with a critical eye and understand the limitations of these trials including the potential for selection bias, inability to discriminate uncommon outcomes and the imprecision of point estimates. When small or underpowered trials are designed to be assessed in combination with other trials in high-quality meta-analysis, some of these limitations are minimized.
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http://dx.doi.org/10.1097/GRF.0000000000000696DOI Listing
June 2022

Maternal Diabetes and Intrapartum Fetal Electrocardiogram.

Am J Perinatol 2022 04 5. Epub 2022 Apr 5.

University of Pittsburgh, Pittsburgh, Pennsylvania.

Objective: Fetal electrocardiogram (ECG) ST changes are associated with fetal cardiac hypoxia. Our objective was to evaluate ST changes by maternal diabetic status and stage of labor.

Methods: This was a secondary analysis of a multicentered randomized-controlled trial in which laboring patients with singleton gestations underwent fetal ECG scalp electrode placement and were randomly assigned to masked or unmasked ST-segment readings. Our primary outcome was the frequency of fetal ECG tracings with ST changes by the stage of labor. ECG tracings were categorized into mutually exclusive groups (ST depression, ST elevation without ST depression, or no ST changes). We compared participants with DM, gestational diabetes mellitus (GDM), and no DM.

Results: Of the 5,436 eligible individuals in the first stage of labor (95 with pregestational DM and 370 with GDM), 4,427 progressed to the second stage. ST depression occurred more frequently in the first stage of labor in participants with pregestational DM (15%, adjusted odds ratio [aOR] 2.20, 95% confidence interval [CI] 1.14-4.24) and with GDM (9.5%, aOR 1.51, 95% CI 1.02-2.25) as compared with participants without DM (5.7%). The frequency of ST elevation was similar in participants with pregestational DM (33%, aOR 0.79, 95% CI 0.48-1.30) and GDM (33.2%, aOR 0.91, 95% CI 0.71-1.17) as compared with those without DM (34.2%). In the second stage, ST depression did not occur in participants with pregestational DM (0%) and occurred more frequently in participants with GDM (3.5%, aOR 2.01, 95% CI 1.02-3.98) as compared with those without DM (2.0%). ST elevation occurred more frequently in participants with pregestational DM (30%, aOR 1.81, 95% CI 1.02-3.22) but not with GDM (19.0%, aOR 1.06, 95% CI 0.77-1.47) as compared with those without DM (17.8%).

Conclusion: ST changes in fetal ECG occur more frequently in fetuses of diabetic mothers during labor.

Clinicaltrials: gov number, NCT01131260.

Precis: ST changes in fetal ECG, a marker of fetal cardiac hypoxia, occur more frequently in fetuses of diabetic parturients.

Key Points: · Fetal hypertrophic cardiomyopathy (HCM) and cardiac dysfunction occur frequently among fetuses of diabetic patients.. · Fetal ECG changes such as ST elevation and depression reflect cardiac hypoxia.. · Fetuses of diabetic patients demonstrate a higher prevalence of fetal ECG tracings with ST changes..
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http://dx.doi.org/10.1055/a-1817-5788DOI Listing
April 2022

Pathologic Assessment of the Placenta: Evidence Compared With Tradition.

Obstet Gynecol 2022 04 10;139(4):660-667. Epub 2022 Mar 10.

Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women & Infants Hospital, Providence, Rhode Island; and the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.

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http://dx.doi.org/10.1097/AOG.0000000000004719DOI Listing
April 2022

Hyperimmune Globulin for Congenital Cytomegalovirus Infection. Reply.

N Engl J Med 2022 03;386(10):1003

George Washington University, Rockville, MD.

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http://dx.doi.org/10.1056/NEJMc2114296DOI Listing
March 2022

Prediction of Cerebral Palsy or Death among Preterm Infants Who Survive the Neonatal Period.

Am J Perinatol 2022 Mar 4. Epub 2022 Mar 4.

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

Objective:  To assess whether neonatal morbidities evident by the time of hospital discharge are associated with subsequent cerebral palsy (CP) or death.

Study Design:  This is a secondary analysis of data from a multicenter placebo-controlled trial of magnesium sulfate for the prevention of CP. The association between prespecified intermediate neonatal outcomes ( = 11) and demographic and clinical factors ( = 10) evident by the time of discharge among surviving infants ( = 1889) and the primary outcome of death or moderate/severe CP at age 2 ( = 73) was estimated, and a prediction model was created.

Results:  Gestational age in weeks at delivery (odds ratio [OR]: 0.74, 95% confidence interval [CI]: 0.67-0.83), grade III or IV intraventricular hemorrhage (IVH) (OR: 5.3, CI: 2.1-13.1), periventricular leukomalacia (PVL) (OR: 46.4, CI: 20.6-104.6), and male gender (OR: 2.5, CI: 1.4-4.5) were associated with death or moderate/severe CP by age 2. Outcomes not significantly associated with the primary outcome included respiratory distress syndrome, bronchopulmonary dysplasia, seizure, necrotizing enterocolitis, neonatal hypotension, 5-minute Apgar score, sepsis, and retinopathy of prematurity. Using all patients, the receiver operating characteristic curve for the final prediction model had an area under the curve of 0.84 (CI: 0.78-0.89). Using these data, the risk of death or developing CP by age 2 can be calculated for individual surviving infants.

Conclusion:  IVH and PVL were the only neonatal complications evident at discharge that contributed to an individual infant's risk of the long-term outcomes of death or CP by age 2. A model that includes these morbidities, gestational age at delivery, and gender is predictive of subsequent neurologic sequelae.

Key Points: · Factors known at hospital discharge are identified which are independently associated with death or CP by age 2.. · A model was created and validated using these findings to counsel parents.. · The risk of death or CP can be calculated at the time of hospital discharge..
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http://dx.doi.org/10.1055/a-1788-6281DOI Listing
March 2022

Predictive performance of newborn small for gestational age by a United States intrauterine vs birthweight-derived standard for short-term neonatal morbidity and mortality.

Am J Obstet Gynecol MFM 2022 05 18;4(3):100599. Epub 2022 Feb 18.

Background: The use of birthweight standards to define small for gestational age may fail to identify neonates affected by poor fetal growth as they include births associated with suboptimal fetal growth.

Objective: This study aimed to compare intrauterine vs birthweight-derived standards to define newborn small for gestational age to predict neonatal morbidity and mortality.

Study Design: This was a secondary analysis of a multicenter observational study of 118,422 births. Live-born singleton, nonanomalous newborns born at 23 to 41 weeks of gestation were included. Those with missing gestational age estimation or without a first- or second-trimester ultrasound to confirm dating, birthweight, or neonatal outcome data were excluded. Birthweight percentile was computed using an intrauterine standard (Hadlock) and a birthweight-derived standard (Olsen). We compared the test characteristics of small for gestational age (birthweight of <10th percentile) by each standard to predict a composite neonatal morbidity and mortality outcome (death before discharge, neonatal intensive care unit admission >48 hours, respiratory distress syndrome, sepsis, necrotizing enterocolitis, grade 3 or 4 intraventricular hemorrhage, or seizures). Severe composite morbidity was analyzed as a secondary outcome and was defined as death, neonatal intensive care unit admission >7 days, necrotizing enterocolitis, grade 3 or 4 intraventricular hemorrhage, or seizures. The areas under the curve using receiver-operating characteristic methodology and proportions of the primary outcome by small for gestational age status were compared by gestational age category at birth (<34, 34 0/7 to 36 6/7, ≥37 weeks).

Results: Of 115,502 mother-newborn dyads in the parent study, 78,203 (67.7%) were included, with most exclusions occurring because of missing or inadequate dating information, multiple gestations, or delivery outside the gestational age range. The primary composite outcome occurred in 9.5% (95% confidence interval, 9.3-9.7), and the severe composite outcome occurred in 5.3% (95% confidence interval, 5.1-5.4). Small for gestational age was diagnosed by intrauterine and birthweight-derived standards in 14.8% and 7.4%, respectively (P<.001). Neonates considered small for gestational age only by the intrauterine standard experienced the primary outcome more than twice as often as those considered non-small for gestational age by both standards (18.4% vs 7.9%; P<.001). For the prediction of the primary outcome, small for gestational age by the intrauterine standard had higher sensitivity (29% vs 15%; P<.001) but lower specificity (87% vs 93%; P<.001) than by the birthweight standard. Both standards had weak performance overall, although the intrauterine standard had a higher area under the curve (0.58 vs 0.53; P<.001). When subanalyzed by gestational age at birth, the difference in areas under the curve was only present among preterm deliveries 34 to 36 competed weeks. Neither standard demonstrated any discrimination for morbidity prediction among term births (area under the curve, 0.50 for both). When the prediction of severe morbidity was compared, the intrauterine still had better overall prediction than the birthweight standard (areas under the curve, 0.65 vs 0.57; P<.001), although this also varied by gestational age at birth.

Conclusion: Among nonanomalous neonates, neither intrauterine nor birthweight-derived standards for small for gestational age accurately predicted neonatal morbidity and mortality, with no discriminatory ability at term. Small for gestational age intrauterine standards performed better than birthweight standards.
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http://dx.doi.org/10.1016/j.ajogmf.2022.100599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097811PMC
May 2022

Association of SARS-CoV-2 Infection With Serious Maternal Morbidity and Mortality From Obstetric Complications.

JAMA 2022 02;327(8):748-759

Department of Women's Health, University of Texas at Austin.

Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity.

Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications.

Design, Setting, And Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period.

Exposures: SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity.

Main Outcomes And Measures: The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth.

Results: Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]).

Conclusions And Relevance: Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications.
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http://dx.doi.org/10.1001/jama.2022.1190DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822445PMC
February 2022

An evaluation of seasonal maternal-neonatal morbidity related to trainee cycles.

Am J Obstet Gynecol MFM 2022 05 2;4(3):100583. Epub 2022 Feb 2.

Department of Obstetrics & Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, TX (Dr Blackwell).

Background: The existence of the "July phenomenon" (worse outcomes related to the presence of new physician trainees in teaching hospitals) has been debated in the literature and media. Previous studies of the phenomenon in obstetrics are limited by the quality and detail of data.

Objective: To evaluate whether the months of June to August, when transitions in trainees occur, are associated with increased maternal and neonatal morbidity.

Study Design: Secondary analysis of an observational cohort of 115,502 mother-infant pairs that delivered at 25 hospitals from March 2008 to February 2011. Inclusion criteria were an individual who had a singleton, nonanomalous live fetus at the onset of labor, and delivered at a hospital with trainees. The primary outcomes were composites of maternal and neonatal morbidity. We evaluated the outcomes by academic quarter during which the delivery occurred, beginning July 1, and by duration of the academic year as a continuous variable. To account for clustering in outcomes at a given delivery location, we applied hierarchical logistic regression with adjustment for hospital as a random effect.

Results: Of 115,502 deliveries, 99,929 met the inclusion criteria. Race and ethnicity, insurance, body mass index, drug use, and the availability of 24/7 maternal-fetal medicine, anesthesia, and neonatology varied by quarter. In adjusted analysis, the frequency of the composite maternal and neonatal morbidity did not differ by quarter. No differences in composite morbidity were observed when using day of the year as a continuous variable (maternal morbidity adjusted odds ratio, 1.00; 95% confidence interval, 0.99-1.00 and neonatal morbidity adjusted odds ratio, 1.00; 95% confidence interval, 1.00-1.01) and after adjustment for hospital as a random effect. Odds of major surgical complications in quarter 2 were twice those in quarter 1. Neonatal injury and intensive care unit were less frequent in later quarters.

Conclusion: Maternal and neonatal morbidity in teaching hospitals was not associated with the academic quarter during which delivery occurred, and there was no evidence of a "July phenomenon".
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http://dx.doi.org/10.1016/j.ajogmf.2022.100583DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9081218PMC
May 2022

Noninvasive Prediction of Congenital Cytomegalovirus Infection After Maternal Primary Infection.

Obstet Gynecol 2022 03;139(3):400-406

Departments of Obstetrics and Gynecology, Brown University, Providence, Rhode Island, University of Texas Medical Branch at Galveston, Galveston, Texas, Northwestern University, Chicago, Illinois, 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 Alabama at Birmingham, Birmingham, Alabama, The Ohio State University, Columbus, Ohio, Duke University, Durham, North Carolina University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, Case Western Reserve University, Cleveland, Ohio, University of Texas Health Science Center at Houston and Children's Memorial Hermann Hospital, Houston, Texas, Stanford University, Stanford, California, University of Texas Southwestern Medical Center, Dallas, Texas University of Pennsylvania, Philadelphia, Pennsylvania, University of Pittsburgh, Pittsburgh, Pennsylvania, Madigan Army Medical Center, Joint Base Lewis-McChord, Washington, and Washington University in St. Louis, St. Louis, Missouri; the Departments of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, and Duke University, Durham, North Carolina; 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 and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.

Methods: We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation).

Results: Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53-0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02-0.07).

Conclusion: We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making.
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http://dx.doi.org/10.1097/AOG.0000000000004691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8857032PMC
March 2022

Risk of Adverse Birth Outcomes in Two Cohorts of Pregnant Women With HIV in Zambia.

Epidemiology 2022 05;33(3):422-430

From the Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: A trial of progesterone to prevent preterm birth among HIV-infected Zambian women [Improving Pregnancy Outcomes with Progesterone (IPOP)] found no treatment effect, but the risk of the primary outcome was among the lowest ever documented in women with HIV. In this secondary analysis, we compare the risks of preterm birth (<37 weeks), stillbirth, and a composite primary outcome comprising the two in IPOP versus an observational pregnancy cohort [Zambian Preterm Birth Prevention Study (ZAPPS)] in Zambia, to evaluate reasons for the low risk in IPOP.

Methods: Both studies enrolled women before 24 gestational weeks, during August 2015-September 2017 (ZAPPS) and February 2018-January 2020 (IPOP). We used linear probability and log-binomial regression to estimate risk differences and risk ratios (RR), before and after restriction and standardization with inverse probability weights.

Results: The unadjusted risk of composite outcome was 18% in ZAPPS (N = 1450) and 9% in IPOP (N = 791) (RR = 2.0; 95% CI = 1.6, 2.6). After restricting and standardizing the ZAPPS cohort to the distribution of IPOP baseline characteristics, the risk remained higher in ZAPPS (RR = 1.6; 95% CI = 1.0, 2.4). The lower risk of preterm/stillbirth in IPOP was only partially explained by measured risk factors.

Conclusions: Possible benefits in IPOP of additional monetary reimbursement, more frequent visits, and group-based care warrant further investigation.
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http://dx.doi.org/10.1097/EDE.0000000000001465DOI Listing
May 2022

Hypertension in pregnancy and adverse outcomes among low-risk nulliparous women expectantly managed at or after 39 weeks: a secondary analysis of a randomised controlled trial.

BJOG 2022 07 6;129(8):1396-1403. Epub 2022 Jan 6.

University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Objective: To evaluate whether hypertensive disorders of pregnancy (HDP) among low-risk nulliparous women expectantly managed at or after 39 weeks of gestation are associated with adverse outcomes.

Design: Secondary analysis of a randomised trial.

Setting: Multicentre, USA.

Population: Individuals in the expectantly managed group who delivered on or after 39 weeks.

Methods: Multivariable analysis to estimate adjusted relative risks (aRR) for binomial outcomes, adjusted odds ratios (aOR) for multinomial outcomes and 95% CI.

Main Outcome Measures: Composite adverse maternal outcome including placental abruption, pulmonary oedema, postpartum haemorrhage, postpartum infection, venous thromboembolism or intensive care unit admission. Secondary outcomes included a composite of perinatal death or severe neonatal complications, mode of delivery, small and large for gestational age and neonatal intermediate or intensive unit length of stay.

Results: Of the 3044 women randomised to expectant management in the original trial, 2718 (89.3%) were eligible for this analysis, of whom 373 (13.7%) developed HDP. Compared with participants who remained normotensive, those who developed HDP were more likely to experience the maternal composite (12% versus 6%, aRR 1.84, 95% CI 1.33-2.54) and caesarean delivery (29% versus 23%, aOR 1.32, 95% CI 1.01-1.71). Differences between the two groups were not significantly different for the adverse perinatal composite (7% versus 5%, aRR 1.38, 95% CI 0.92-2.07) or for other secondary outcomes.

Conclusion: Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed HDP, and were more likely to experience adverse maternal outcomes compared with those who did not develop HDP.

Tweetable Abstract: Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed hypertensive disorders of pregnancy, and were more likely to experience adverse maternal outcomes compared with those who did not develop hypertensive disorders.
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http://dx.doi.org/10.1111/1471-0528.17059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9207156PMC
July 2022

Neonatal Birthweight, Infant Feeding, and Childhood Metabolic Markers.

Am J Perinatol 2022 04 16;39(6):584-591. Epub 2021 Dec 16.

University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.

Objective: Antenatal and early neonatal nutritional environment may influence later metabolic health. Infants of mothers with gestational diabetes mellitus (GDM) have higher risk for childhood obesity and metabolic syndrome (MetS). Leptin and adiponectin are known biomarkers for MetS and may guide interventions to reduce later obesity. We sought to examine the relationship between birthweight, early infancy feeding practices, and biomarkers for MetS in offspring of women with mild GDM.

Study Design: Secondary analysis of a prospective observational follow-up study on the offspring of women who participated in a multicenter randomized treatment trial on mild GDM. Children were evaluated by research coordinators and biospecimens collected at the age of 5 to 10. Plasma concentrations of leptin and adiponectin were compared between large for gestational age (LGA) and average birthweight (AGA) infants, and according to whether solid foods were introduced early (<6 months of age) or at the recommended age (≥6 months of age). Multivariable analysis adjusted for fetal sex, race/ethnicity, and maternal body mass index.

Results: Leptin and adiponectin were measured in 336 plasma samples. In bivariate analysis, compared with AGA children, LGA children had lower leptin (5.0 ng/mL [3.6-6.0] vs. 5.8 ng/mL [4.5 = 6.6],  = 0.01) and similar adiponectin (6.3 µg/mL [5.1-7.9] vs. 6.4 µg/mL [5.3-8.6],  = 0.49) concentrations. Maternal/child characteristics were similar between the early/delayed solid feeding groups. Leptin and adiponectin concentrations were similar in the early fed and delayed feeding groups (5.8 ng/mL [4.6-6.7] vs. 5.6 ng/mL [4.2-6.6],  = 0.50 and 6.4 µg/mL [5.4-8.1] vs. 6.4 µg/mL [5.1-8.8],  = 0.85, respectively). After controlling for covariates, children who were LGA and AGA at birth had similar leptin concentrations.

Conclusion: Birthweight and early infancy feeding practice are not associated with alterations in leptin and adiponectin in children of women with mild GDM.

Key Points: · Adipocytokines are markers of metabolic status.. · Children of women with mild GDM may be at risk for MetS.. · Biomarkers similar in LGA and AGA groups.. · Biomarkers similar in early and delayed solid-fed groups.. · Nonhuman milk does not modify effect of feeding practice..
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http://dx.doi.org/10.1055/s-0041-1740056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9106839PMC
April 2022

Racial and Ethnic Inequities in Cesarean Birth and Maternal Morbidity in a Low-Risk, Nulliparous Cohort.

Obstet Gynecol 2022 01;139(1):73-82

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 at Galveston, 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 Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, 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 race and ethnicity differences in cesarean birth and maternal morbidity in low-risk nulliparous people at term.

Methods: We conducted a secondary analysis of a randomized trial of expectant management compared with induction of labor in low-risk nulliparous people at term. The primary outcome was cesarean birth. Secondary outcome was maternal morbidity, defined as: transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death. Multivariable modified Poisson regression was used to evaluate associations between race and ethnicity, cesarean birth, and maternal morbidity. Indication for cesarean birth was assessed using multivariable multinomial logistic regression. A mediation model was used to estimate the portion of maternal morbidity attributable to cesarean birth by race and ethnicity.

Results: Of 5,759 included participants, 1,158 (20.1%) underwent cesarean birth; 1,404 (24.3%) identified as non-Hispanic Black, 1,670 (29.0%) as Hispanic, and 2,685 (46.6%) as non-Hispanic White. Adjusted models showed increased relative risk of cesarean birth among non-Hispanic Black (adjusted relative risk [aRR] 1.21, 95% CI 1.03-1.42) and Hispanic (aRR 1.26, 95% CI 1.08-1.46) people compared with non-Hispanic White people. Maternal morbidity affected 132 (2.3%) individuals, and was increased among non-Hispanic Black (aRR 2.05, 95% CI 1.21-3.47) and Hispanic (aRR 1.92, 95% CI 1.17-3.14) people compared with non-Hispanic White people. Cesarean birth accounted for an estimated 15.8% (95% CI 2.1-48.7%) and 16.5% (95% CI 4.0-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively.

Conclusion: Non-Hispanic Black and Hispanic nulliparous people who are low-risk at term undergo cesarean birth more frequently than low-risk non-Hispanic White nulliparous people. This difference accounts for a modest portion of excess maternal morbidity.
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http://dx.doi.org/10.1097/AOG.0000000000004620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8678297PMC
January 2022

Prenatal Nicotine or Cannabis Exposure and Offspring Neurobehavioral Outcomes.

Obstet Gynecol 2022 01;139(1):21-30

Departments of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah, University of Texas-Southwestern, Dallas, Texas, 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, Northwestern University, Chicago, Illinois, Brown University, Providence, Rhode Island, University of Texas-Houston, Houston, Texas, The Ohio State University, Columbus, Ohio, Case Western Reserve University, Cleveland, Ohio, and University of Pittsburgh, Pittsburgh, Pennsylvania; the Department of Pathology, University of Utah Health and ARUP Laboratories, Salt Lake City, Utah; 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 study the association between nicotine or cannabis metabolite presence in maternal urine and child neurodevelopmental outcomes.

Methods: We conducted a secondary analysis of two parallel multicenter randomized controlled trials of treatment for hypothyroxinemia or subclinical hypothyroidism among pregnant individuals enrolled at 8-20 weeks of gestation. All maternal-child dyads with a maternal urine sample at enrollment and child neurodevelopmental testing were included (N=1,197). Exposure was urine samples positive for nicotine (cotinine) or cannabis 11-nor-9-carboxy-delta-9-tetrahydrocannabinol [THC-COOH]) or both metabolites. Primary outcome was child IQ at 60 months. Secondary outcomes included cognitive, motor and language, attention, behavioral and social competency, and differential skills assessments at 12, 24, 36, and 48 months. Quantile regression analysis was performed with confounder adjustment.

Results: Of 1,197 pregnant individuals, 99 (8.3%) had positive cotinine samples and 47 (3.9%) had positive THC-COOH samples; 33 (2.8%) were positive for both. Groups differed in self-reported race and ethnicity, education, marital status, insurance, and thyroid status. Median IQ was similar between cotinine-exposed and -unexposed children (90 vs 95, adjusted difference in medians -2.47, 95% CI -6.22 to 1.29) and THC-COOH-exposed and -unexposed children (89 vs 95, adjusted difference in medians -1.35, 95% CI -7.76 to 5.05). In secondary outcome analysis, children with THC-COOH exposure compared with those unexposed had higher attention scores at 48 months of age (57 vs 49, adjusted difference in medians 6.0, 95% CI 1.11-10.89).

Conclusions: Neither prenatal nicotine nor cannabis exposure was associated with a difference in IQ. Cannabis exposure was associated with worse attention scores in early childhood. Longitudinal studies assessing associations between child neurodevelopmental outcomes and prenatal nicotine and cannabis exposure with a focus on timing and quantity of exposure are needed.

Clinical Trial Registration: ClinicalTrials.gov, NCT00388297.
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http://dx.doi.org/10.1097/AOG.0000000000004632DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8715943PMC
January 2022

Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial.

Am J Perinatol 2022 06 28;39(8):808-815. Epub 2021 Nov 28.

Department of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island, Alpert Medical School of Brown University, Providence, Rhode Island.

Objective: Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA.

Study Design: This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol.

Results: The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%,  = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%,  = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups.

Conclusion: IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227.

Key Points: · IV iron decreases rates of anemia on admission for delivery compared with oral iron.. · In an unblinded randomized trial, a significant proportion of patients preferred alternate therapy.. · Future RCTs should incorporate double-blinded technique to reduce risk of patient crossover.. · Results from feasibility trial support a larger RCT comparing IV to oral iron for IDA in pregnancy..
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http://dx.doi.org/10.1055/s-0041-1740003DOI Listing
June 2022

Health Outcomes Associated With Clinician-initiated Delivery for Hypertensive Disorders at 34-38 Weeks' Gestation.

Epidemiology 2022 03;33(2):260-268

From the Department of Epidemiology, Brown University, Providence, RI.

Background: Clinicians caring for the nearly 10% of patients in the United States with nonsevere hypertensive disorders in late pregnancy need better evidence to balance risks and benefits of clinician-initiated delivery.

Methods: We conducted a record-based cohort study of maternal and infant health outcomes among deliveries from 2002-2013 at Women & Infants Hospital of Rhode Island. Participants had gestational hypertension or nonsevere preeclampsia before 39 weeks' gestation (N=4,295). For each gestational week from 34 to 38, we compared outcomes between clinician-initiated deliveries (induction of labor or prelabor cesarean) and those not initiated in that week, using propensity score models to control confounding by indication.

Results: The analysis predicted an increment in risk of adverse maternal and infant outcomes sustained through week 37 if all patients underwent clinician-initiated delivery, with risk differences on the order of 0.2 for maternal outcomes and 0.3 for infant outcomes weeks 34 and 35. For women undergoing clinician-initiated delivery, the analysis identified increased risk of progression to severe disease in weeks 35 and 36, increases in all adverse infant outcomes only in week 34, increases in Neonatal Intensive Care Unit admission and infant hospital stay in weeks 35 and 36, and no meaningful increase in any of the adverse outcomes in weeks 37 or 38.

Conclusions: We estimate that hypertensive pregnancies chosen for intervention were minimally harmed by early delivery after 34 weeks' gestation but predict benefit from extension to 37 weeks. Our study also showed adverse infant health consequences associated with routine delivery prior to 37 weeks.
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http://dx.doi.org/10.1097/EDE.0000000000001442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8810678PMC
March 2022

Oral Glucose Tolerance Test in Pregnancy and Subsequent Maternal Hypertension.

Am J Perinatol 2021 Nov 16. Epub 2021 Nov 16.

Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.

Objective:  The aim of the study is to evaluate whether values and the shape of the glucose curve during the oral glucose tolerance test (OGTT) in pregnancy identify women at risk of developing hypertension (HTN) later in life.

Methods:  This category includes the secondary analysis of a follow-up from a mild gestational diabetes mellitus (GDM) study that included a treatment trial for mild GDM ( = 458) and an observational cohort of participants with abnormal 1-hour glucose loading test only (normal OGTT,  = 430). Participants were assessed at a median of 7 (IQR 6-8) years after their index pregnancy, and trained staff measured their blood pressure (systolic blood pressure [SBP]; diastolic blood pressure [DBP]). The association between values and the shape of the glucose curve during OGTT in the index pregnancy and the primary outcome defined as elevated BP (SBP ≥120, DBP ≥80 mm Hg, or receiving anti-HTN medications), and secondary outcome defined as stage 1 or higher (SBP ≥130, DBP ≥80 mm Hg, or receiving anti-HTN medications) at follow-up were evaluated using multivariable regression, adjusting for maternal age, body mass index, and pregnancy-associated hypertension during the index pregnancy.

Results:  There was no association between fasting, 1-hour OGTT, and the outcomes. However, the 2-hour OGTT value was positively associated (adjusted odds ratio [aRR] per 10-unit increase 1.04, 95% CI 1.01-1.08), and the 3-hour was inversely associated (aRR per 10-unit increase 0.96, 95% CI 0.93-0.99) with the primary outcome. When the shape of the OGTT curve was evaluated, a monophasic OGTT response (peak at 1 hour followed by a decline in glucose) was associated with increased risk of elevated BP (41.3vs. 23.5%, aRR 1.66, 95% CI 1.17-2.35) and stage 1 HTN or higher (28.5 vs. 14.7%, aRR 1.83, 95% CI 1.15-2.92), compared with a biphasic OGTT response.

Conclusion:  Among persons with mild GDM or lesser degrees of glucose intolerance, the shape of the OGTT curve during pregnancy may help identify women who are at risk of HTN later in life, with biphasic shape to be associated with lower risk.

Key Points: · The shape of the Oral Glucose Tolerance Test curve may help identify patients who are at risk of having elevated BP or HTN 5 to 10 years following pregnancy.. · The 2-hour Oral Glucose Tolerance Test values is positively associated with elevated BP 5 to 10 years following pregnancy.. · This supports the concept of pregnancy as a window to future health and represents a potential novel biomarker for maternal cardiovascular health screening..
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http://dx.doi.org/10.1055/s-0041-1740007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108113PMC
November 2021

Association between Hypertensive Disorders of Pregnancy and Long-Term Neurodevelopmental Outcomes in the Offspring.

Am J Perinatol 2022 07 29;39(9):921-929. Epub 2021 Dec 29.

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

Objective: The long-term impact of hypertensive disorders of pregnancy (HDP) exposure on offspring health is an emerging research area. The objective of this study was to evaluate the association between a maternal diagnosis of HDP (gestational hypertension and preeclampsia) and adverse neurodevelopmental outcomes in the offspring.

Study Design: This was a secondary analysis of two parallel multicenter clinical trials of thyroxine therapy for subclinical hypothyroid disorders in pregnancy. Women with singleton nonanomalous gestations diagnosed with subclinical hypothyroidism or hypothyroxinemia were randomized to thyroxine therapy or placebo. The primary outcome was child intelligence quotient (IQ) at 5 years of age. Secondary outcomes included several neurodevelopmental measures, including the Bayley-III cognitive, motor, and language scores at 12 and 24 months, Differential Ability Scales-II (DAS-II) scores at 36 months, the Conners' rating scales-revised at 48 months, and scores from the Child Behavior Checklist at 36 and 60 months. Thyroxine therapy did not influence neurodevelopment in either of the primary studies. Associations between neurodevelopment outcomes and maternal HDP were examined using univariable and multivariable analyses.

Results: A total of 112 woman-child dyads with HDP were compared with 1,067 woman-child dyads without HDP. In univariable analysis, mean maternal age (26.7 ± 5.9 vs. 27.8 ± 5.7 years,  = 0.032) and the frequency of nulliparity (45.5 vs. 31.0%,  = 0.002) differed significantly between the two groups. Maternal socioeconomic characteristics did not differ between the groups. After adjusting for potential confounders, there were no significant differences in any primary or secondary neurodevelopment outcome between offspring exposed to HDP and those unexposed. However, when dichotomized as low or high scores, we found higher rates of language delay (language scores <85: -1 standard deviation) at 2 years of age among offspring exposed to HDP compared with those unexposed (46.5 vs. 30.5%, adjusted odds ratio = 2.22, 95% confidence interval [CI]: 1.44-3.42).

Conclusion: In this cohort of pregnant women, HDP diagnosis was associated with language delay at 2 years of age. However, other long-term neurodevelopmental outcomes in offspring were not associated with HDP.

Key Points: · No differences were found in neurodevelopment between offspring exposed to HDP and controls.. · Higher rates of language delay at 2 years of age were found in offspring exposed to HDP.. · The results did not differ when analysis was stratified by preterm birth..
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http://dx.doi.org/10.1055/a-1692-0659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9081295PMC
July 2022
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