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ImportanceBirth in the periviable period between 22 weeks 0 days and 25 weeks 6 days’ gestation is a major source of neonatal morbidity and mortality, and the decision to initiate active life-saving treatment is challenging.ObjectiveTo assess whether the frequency of active treatment among live-born neonates in the periviable period has changed over time and whether active treatment differed by gestational age at birth and race and ethnicity.Design, Setting, and ParticipantsSerial cross-sectional descriptive study using National Center for Health Statistics natality data from 2014 to 2020 for 61 908 singleton live births without clinical anomalies between 22 weeks 0 days and 25 weeks 6 days in the US.ExposuresYear of delivery, gestational age at birth, and race and ethnicity of the pregnant individual, stratified as non-Hispanic Asian/Pacific Islander, non-Hispanic Black, Hispanic/Latina, and non-Hispanic White.Main Outcomes and MeasuresActive treatment, determined by whether there was an attempt to treat the neonate and defined as a composite of surfactant therapy, immediate assisted ventilation at birth, assisted ventilation more than 6 hours in duration, and/or antibiotic therapy. Frequencies, mean annual percent change (APC), and adjusted risk ratios (aRRs) were estimated.ResultsOf 26 986 716 live births, 61 908 (0.2%) were periviable live births included in this study: 5% were Asian/Pacific Islander, 37% Black, 24% Hispanic, and 34% White; and 14% were born at 22 weeks, 21% at 23 weeks, 30% at 24 weeks, and 34% at 25 weeks. Fifty-two percent of neonates received active treatment. From 2014 to 2020, the overall frequency (mean APC per year) of active treatment increased significantly (3.9% [95% CI, 3.0% to 4.9%]), as well as among all racial and ethnic subgroups (Asian/Pacific Islander: 3.4% [95% CI, 0.8% to 6.0%]); Black: 4.7% [95% CI, 3.4% to 5.9%]; Hispanic: 4.7% [95% CI, 3.4% to 5.9%]; and White: 3.1% [95% CI, 1.1% to 4.4%]) and among each gestational age range (22 weeks: 14.4% [95% CI, 11.1% to 17.7%] and 25 weeks: 2.9% [95% CI, 1.5% to 4.2%]). Compared with neonates born to White individuals (57.0%), neonates born to Asian/Pacific Islander (46.2%; risk difference [RD], −10.81 [95% CI, −12.75 to −8.88]; aRR, 0.82 [95% CI, [0.79-0.86]), Black (51.6%; RD, −5.42 [95% CI, −6.36 to −4.50]; aRR, 0.90 [95% CI, 0.89 to 0.92]), and Hispanic (48.0%; RD, −9.03 [95% CI, −10.07 to −7.99]; aRR, 0.83 [95% CI, 0.81 to 0.85]) individuals were significantly less likely to receive active treatment.Conclusions and RelevanceFrom 2014 to 2020 in the US, the frequency of active treatment among neonates born alive between 22 weeks 0 days and 25 weeks 6 days significantly increased, and there were differences in rates of active treatment by race and ethnicity.

To examine the association between initial COVID-19 vaccine hesitancy and subsequent vaccination among pregnant and postpartum individuals.Prospective cohort.A Midwestern tertiary-care academic medical center. Individuals completed a baseline vaccine hesitancy assessment from 22 March 2021 to 2 April 2021, with subsequent ascertainment of vaccination status at 3-6 months follow-up.We used multivariable Poisson regression to estimate the relative risk of vaccination by baseline vaccine hesitancy status, and then characteristics associated with vaccination.Self-report of COVID-19 vaccination, and secondarily, consideration of COVID-19 vaccination among those not vaccinated.Of 456 individuals (93% pregnant, 7% postpartum) initially surveyed, 290 individuals (64%; 23% pregnant, 77% postpartum) provided subsequent vaccination status (median = 17 weeks). Of these 290 individuals, 40% (116/290) reported COVID-19 vaccine hesitancy upon enrolment, of whom 52% reported subsequent vaccination at follow-up. Few individuals transitioned during the study period from vaccine hesitant to vaccinated (10%); in comparison, 80% of those who were not vaccine hesitant were vaccinated at follow-up (aRR 0.19, 95% CI 0.11-0.33). Among those who remained unvaccinated at follow-up, 38% who were vaccine hesitant at baseline were considering vaccination, compared with 71% who were not vaccine hesitant (aRR 0.48, 95% CI 0.33-0.67). Individuals who were older, parous, employed and of higher educational attainment were more likely to be vaccinated, and those who identified as non-Hispanic black, were Medicaid beneficiaries, and were still pregnant at follow-up were less likely to be vaccinated.COVID-19 vaccine hesitancy persisted over time in the peripartum period, and few individuals who reported hesitancy at baseline were later vaccinated. Interventions that address vaccine hesitancy in pregnancy are needed.

To evaluate the association between community-level social vulnerability and achieving glycemic control (defined as hemoglobin A1c [Hb A1c] less than 6.0% or less than 6.5%) among individuals with pregestational diabetes.We conducted a retrospective cohort of individuals with pregestational diabetes with singleton gestations from 2012 to 2016 at a tertiary care center. Addresses were geocoded using ArcGIS and then linked at the census tract to the Centers for Disease Control and Prevention's 2018 SVI (Social Vulnerability Index), which incorporates 15 Census variables to produce a composite score and four scores across thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). Scores range from 0 to 1, with higher values indicating greater community-level social vulnerability. The primary outcome was Hb A1c less than 6.0%, and, secondarily, Hb A1c less than 6.5%, in the second or third trimesters. Multivariable Poisson regression with robust error variance was used to evaluate the association between SVI score as a continuous measure and target Hb A1c.Among 418 assessed pregnant individuals (33.0% type 1; 67.0% type 2 diabetes), 41.4% (173/418) achieved Hb A1c less than 6.0%, and 56.7% (237/418) Hb A1c less than 6.5% at a mean gestational age of 29.5 weeks (SD 5.78). Pregnant individuals with a higher SVI score were less likely to achieve Hb A1c less than 6.0% compared with those with a lower SVI score. For each 0.1-unit increase in SVI score, the risk of achieving Hb A1c less than 6.0% decreased by nearly 50% (adjusted risk ratio [aRR] 0.53; 95% CI 0.36-0.77), and by more than 30% for Hb A1c less than 6.5% (adjusted odds ratio 0.67; 95% CI 0.51-0.88). With regard to specific SVI domains, those who scored higher on socioeconomic status (aRR 0.50; 95% CI 0.35-0.71) as well as on household composition and disability (aRR 0.55; 95% CI 0.38-0.79) were less likely to achieve Hb A1c less than 6.0%.Pregnant individuals with pregestational diabetes living in an area with higher social vulnerability were less likely to achieve glycemic control, as measured by HgbA1c levels. Interventions are needed to assess whether addressing social determinants of health can improve glycemic control in pregnancy.

Objective We estimated the association between diabetes and shoulder dystocia by infant birth weight subgroups (4,500 g) in an era of prophylactic cesarean delivery for suspected macrosomia.Study Design A secondary analysis from the National Institute of Child Health and Human Development U.S. Consortium for Safe Labor of deliveries at ≥24 weeks with a nonanomalous, singleton fetus with vertex presentation undergoing a trial of labor. The exposure was either pregestational or gestational diabetes compared with no diabetes. The primary outcome was shoulder dystocia and secondarily, birth trauma with a shoulder dystocia. We calculated adjusted risk ratios (aRRs) with modified Poison's regression between diabetes and shoulder dystocia and the number needed to treat (NNT) to prevent a shoulder dystocia with cesarean delivery.Results Among 167,589 assessed deliveries (6% with diabetes), pregnant individuals with diabetes had a higher risk of shoulder dystocia at birth weight 4,500 g (aRR: 1.26; 95% CI: 0.87–1.82) versus those without diabetes. The risk of birth trauma with shoulder dystocia was higher with diabetes (aRR: 2.29; 95% CI: 1.54–3.45). The NNT to prevent a shoulder dystocia with diabetes was 11 and 6 at ≥4,000 and >4,500 g, versus without diabetes, 17 and 8 at ≥4,000 and >4,500 g, respectively.Conclusion Diabetes increased the risk of shoulder dystocia, even at lower birth weight thresholds than at which cesarean delivery is currently offered. Guidelines providing the option of cesarean delivery for suspected macrosomia may have decreased the risk of shoulder dystocia at higher birth weights.Key Points

To assess the frequency and associated characteristics of COVID-19 vaccine hesitancy among pregnant and postpartum individuals.Cross-sectional study.Prenatal care at a single academic tertiary care centre.Pregnant and postpartum individuals enrolled in prenatal care at a single academic tertiary care centre from 22 March 2021 to 2 April 2021, concurrent with state guidelines recommending COVID-19 vaccination in pregnancy.We used logistic regression to identify characteristics associated with COVID-19 vaccine hesitancy, and adjusted for: age, parity, race, trimester of pregnancy, and chronic comorbidities.COVID-19 vaccine hesitancy, defined as uncertainty or refusal of the vaccine, despite the availability of vaccine services, in accordance with the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on vaccine hesitancy.Of the 485 individuals screened and approached, 456 (94%) enrolled and completed the survey (435/456, 95% pregnant). The frequency of COVID-19 vaccine hesitancy was 46% (95% CI 41%-51%). Sociodemographic characteristics, including non-Hispanic Black race, younger age, lower education, public health insurance receipt, parity1, and reported substance use, were associated with a higher odds of COVID-19 vaccine hesitancy, but not clinical risk conditions. Individuals who had a family or friend vaccinated for COVID-19, prior or planned vaccination for tetanus, diphtheria and acellular pertussis (Tdap) and/or influenza, and who perceived that vaccination benefited the baby were less likely to express COVID-19 vaccine hesitancy.COVID-19 vaccine hesitancy was frequent among pregnant and postpartum individuals. Those who may face barriers to accessing healthcare services were more likely to report vaccine hesitancy. These results can inform interventions to increase COVID-19 vaccine uptake in pregnancy.COVID-19 vaccination hesitancy is frequent among pregnant and postpartum individuals, and those who face barriers to accessing healthcare services are more likely to report COVID-19 vaccine hesitancy.

Preeclampsia is a common hypertensive disorder of pregnancy associated with considerable neonatal and maternal morbidities and mortalities. However, the exact cause of preeclampsia remains unknown; it is generally accepted that abnormal placentation resulting in the release of soluble antiangiogenic factors, coupled with increased oxidative stress and inflammation, leads to systemic endothelial dysfunction and the clinical manifestations of the disease. Statins have been found to correct similar pathophysiological pathways that underlie the development of preeclampsia. Pravastatin, specifically, has been reported in various preclinical and clinical studies to reverse the pregnancy-specific angiogenic imbalance associated with preeclampsia, to restore global endothelial health, and to prevent oxidative and inflammatory injury. Human studies have found a favorable safety profile for pravastatin, and more recent evidence does not support the previous teratogenic concerns surrounding statins in pregnancy. With reassuring and positive findings from pilot studies and strong biological plausibility, statins should be investigated in large clinical randomized-controlled trials for the prevention of preeclampsia.

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.

OBJECTIVE This study aimed to investigate the association between excess and less than recommended gestational weight gain (GWG) and adverse maternal and neonatal outcomes in women with pregestational and gestational diabetes. STUDY DESIGN We conducted a secondary analysis of the National Institute of Child Health and Human Development (NICHD) Consortium on Safe Labor (CSL) study. We included deliveries >23 weeks of nonanomalous singletons with either pregestational or gestational diabetes. The exposure was GWG greater than or less than compared with the U.S. Institute of Medicine recommendations for total pregnancy weight gain per prepregnancy body mass index. Consistent with the 2020 Delphi outcome for diabetes in pregnancy, maternal outcomes included cesarean delivery and preeclampsia and neonatal outcomes included small for gestational age (SGA), large for gestational age (LGA), macrosomia >4,000 g, preterm birth

Treatment with monoclonal antibodies has been shown to significantly reduce the risk of hospitalization and disease progression among high-risk patients with coronavirus disease 2019 (COVID-19). Pregnant individuals were excluded from the original trials. In this single-center retrospective cohort study, we evaluated whether monoclonal antibody treatment in pregnant individuals is associated with decreased risk of hospitalization. Outcomes of patients who received the treatment were compared with those who were eligible but did not receive the treatment. Analyses were stratified by vaccination status. Unvaccinated pregnant patients with mild or moderate COVID-19 who received outpatient monoclonal antibodies were less likely to be admitted to the hospital (4.2% vs 15.7%, odds ratio 0.24, 95% CI 0.07-0.74), whereas among vaccinated patients, the treatment was not associated with a lower rate of hospitalization (2.3% vs 0%, P=.99).

Remdesivir has been shown to shorten the time to recovery in hospitalized patients with coronavirus disease 2019 (COVID-19). Data on its use in pregnancy are limited. In this single-center retrospective cohort study, our objective was to determine whether early remdesivir use in pregnant individuals is associated with decreased risk of admission to the intensive care unit (ICU). Forty-one pregnant patients were included in this study, and outcomes were compared between those who received remdesivir less than 7 days (early group) and 7 or more days (late group) from onset of patient-reported symptoms. Early remdesivir administration was associated with improved clinical outcomes, including lower rates of ICU admission, decreased length of hospitalization, and decreased progression to critical disease in pregnant individuals hospitalized with COVID-19.

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.)

PROBLEM: Since the start of the pandemic, Pregnant individuals have been disproportionately affected by the severe acute respiratory syndrome coronavirus 2. Vaccination has been shown to be protective against severe disease. However, data on effectiveness of vaccine in reducing disease severity are limited in pregnant individuals who later developed COVID-19. METHOD OF STUDY: This is a single academic center retrospective cohort study of pregnant individuals who tested positive for COVID-19 from December 2020 through January 2022. The cohort was divided into two groups based on vaccination status. The primary outcome of our study was progression to severe or critical disease. A secondary analysis was performed based on the timeframes of predominance of different variants of SARS-CoV-2, to determine whether the effect of vaccination was different during these epochs. RESULTS: Our cohort included 472 patients among which 125 (26.5%) were vaccinated and 347 were unvaccinated. None of the patients in the vaccinated group who later developed COVID-19 progressed to severe or critical disease compared to 7.2% in the unvaccinated one (p < .01). Similarly, after adjusting for medical comorbidities, obesity, receipt of monoclonal antibodies, and trimester at diagnosis, vaccinated individuals who later developed COVID-19 were less likely to be admitted to the hospital (1.6% vs. 14.7%, aOR .14, 95% CI .22-.47) compared with unvaccinated ones. CONCLUSION: Vaccination against SARS-CoV-2 in pregnant individuals who later develop a breakthrough infection, is associated with decreased progression to severe or critical COVID-19, and need for hospital and ICU admissions. Vaccination is specifically effective during the predominance of the more severe Delta variant.

SARS-CoV-2 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 the risk persists later in pregnancy.This study aimed to evaluate whether the risk of SARS-CoV-2 infection during pregnancy persists after an acute maternal illness.A retrospective cohort study of pregnant patients with and without SARS-CoV-2 infection delivering at 17 hospitals in the United States between March 2020 and December 2020. Patients experiencing a SARS-CoV-2-positive test at or before 28 weeks of 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 at20 weeks of gestation in both groups were excluded. The study outcomes included fetal or neonatal death, preterm birth at37 weeks of gestation and34 weeks of gestation, hypertensive disorders of pregnancy (HDP), any major congenital malformation, and size for gestational age of5th or10th percentiles at birth based on published standards. HDP that were collected included HDP and preeclampsia with severe features, both overall and with delivery at37 weeks of gestation.Of 2326 patients who tested positive for SARS-CoV-2 during pregnancy and were at least 20 weeks of gestation at delivery from March 2020 to December 2020, 402 patients (delivering 414 fetuses or neonates) were SARS-CoV-2 positive before 28 weeks of gestation and before their admission for delivery; they were compared with 11,705 patients without a positive SARS-CoV-2 test. In adjusted analyses, those with SARS-CoV-2 before 28 weeks of gestation had a subsequent increased risk of fetal or neonatal death (2.9% vs 1.5%; adjusted relative risk, 1.97; 95% confidence interval, 1.01-3.85), preterm birth at37 weeks of gestation (19.6% vs 13.8%; adjusted relative risk, 1.29; 95% confidence interval, 1.02-1.63), and HDP with delivery at37 weeks of gestation (7.2% vs 4.1%; adjusted relative risk, 1.74; 95% confidence interval, 1.19-2.55). There was no difference in the rates of preterm birth at34 weeks of gestation, any major congenital malformation, and size for gestational age of5th or10th percentiles. In addition, there was no significant difference in the rate of gestational hypertension overall or preeclampsia with severe features.There was a modest increase in the risk of adverse pregnancy outcomes after SARS-CoV-2 infection.

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.

Pregnant patients with severe or critical coronavirus disease 2019 (COVID-19), but not those with mild or moderate COVID-19, were at increased risk for perinatal complications compared with asymptomatic patients., 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

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

Rotational thromboelastometry (ROTEM) is a point-of-care viscoelastic test used in trauma for goal-directed transfusion. However, there are limited data on baseline ROTEM parameters in the U.S. obstetric population. Obtaining baseline parameters is a first step in implementing a goal-directed massive transfusion protocol in obstetric hemorrhage. Our study aimed to establish pre- and postdelivery baseline parameters in a high-risk obstetric population and determine their association with postpartum hemorrhage (PPH). Prospective observational study of patients ≥34 weeks' gestation, at high risk of PPH, admitted for delivery. INTEM, EXTEM, FIBTEM, and APTEM assays were performed at the time of admission to labor and delivery and then 2 hours after delivery. Primary outcome was pre- and postdelivery ROTEM parameters among women without PPH. A sample size of 60 women was needed for90% power to detect at least 50% correlation between pre- and postdelivery assuming a loss of 10% of participants to follow-up. Of 60 women in the study, 10 (17%) had PPH. Baseline characteristics were not different between those with or without PPH. Pre- and postdelivery ROTEM parameters were not significantly different except for APTEM. None of the patients who had PPH, compared with 4 (10%) of those who did not, had shortened clotting time and higher maximum clot firmness in postdelivery APTEM compared with EXTEM, a pattern suggestive of hyperfibrinolysis ( In this study, we describe baseline ROTEM parameters in women at high risk of PPH. The majority of patients did not have a ROTEM pattern that is suggestive of hyperfibrinolysis, for which tranexamic acid is thought to be beneficial. Based on our findings, previously established obstetric transfusion thresholds for goal-directed massive transfusion protocols are likely valid for the majority of the obstetric population regardless of the presence of comorbidities or pregnancy complications.· ROTEM parameters do not vary significantly before and after delivery.. · Most patients did not have a hyperfibrinolysis pattern, for which tranexamic acid is thought to be beneficial.. · Previous goal-directed obstetric transfusion thresholds are likely valid in most populations..

Objective This study aimed to develop and validate a model to predict the probability of vaginal delivery (VD) in low-risk term nulliparous patients, and to determine whether it can predict the risk of severe maternal and neonatal morbidity. Methods Secondary analysis of an obstetric cohort of patients and their neonates born in 25 hospitals across the United States (n = 115,502). Trained and certified research personnel abstracted the maternal and neonatal records. Nulliparous patients with singleton, nonanomalous vertex fetuses, admitted with an intent for VD ≥ 37 weeks were included in this analysis. Patients in active labor (cervical exam > 5 cm), those with prior cesarean and other comorbidities were excluded. Eligible patients were randomly divided into a training and test sets. Based on the training set, and using factors available at the time of admission for delivery, we developed and validated a logistic regression model to predict the probability of VD, and then estimated the prevalences of severe morbidity according to the predicted probability of VD. Results A total of 19,611 patients were included. Based on the training set (n = 9,739), a logistic regression model was developed that included maternal age, body mass index (BMI), cervical dilatation, and gestational age on admission. The model was internally validated on the test set (n = 9,872 patients) and yielded a receiver operating characteristic-area under the curve (ROC-AUC) of 0.71 (95% confidence interval [CI]: 0.70–0.72). Based on a subset of 18,803 patients with calculated predicted probabilities, we demonstrated that the prevalences of severe morbidity decreased as the predicted probability of VD increased (p Conclusion In a large cohort of low-risk nulliparous patients in early labor or undergoing induction of labor, at term with singleton gestations, we developed and validated a model to calculate the probability of VD, and maternal and neonatal morbidity. If externally validated, this calculator may be clinically useful in helping to direct level of care, staffing, and adjustment for case-mix among various systems. Key Points

Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points Pregnancy was excluded from past pandemic research. Pregnancy is being excluded from COVID-19 research. Exclusion of pregnant women is potentially harmful.

We sought to provide a clinical practice protocol for our labor and delivery (LD) unit, to care for confirmed or suspected COVID-19 patients requiring cesarean delivery. A multidisciplinary team approach guidance was designed to simplify and streamline the flow and care of patient with confirmed or suspected COVID-19 requiring cesarean delivery. A protocol was designed to improve staff readiness, minimize risks, and streamline care processes. This is a suggested protocol which may not be applicable to all health care settings but can be adapted to local resources and limitations of individual LD units. Guidance and information are changing rapidly; therefore, we recommend continuing to update the protocol as needed. KEY POINTS: · Cesarean delivery for confirmed or suspected novel coronavirus disease 2019 (COVID-19) patients. · Team-based approach for streamline care. · Labor and delivery protocols for COVID-19 positive patients.

Objective To estimate the effect of antenatal treatment of subclinical hypothyroidism on maternal depressive symptoms. Methods We conducted an ancillary study to a multicenter trial in women with singleton pregnancies diagnosed with subclinical hypothyroidism randomized to antenatal thyroxine therapy or placebo. Treatment was discontinued at the end of pregnancy. Women with overt thyroid disease, diabetes, autoimmune disease, and those diagnosed with depression were excluded. Participants were assessed for depressive symptoms using the Center for Epidemiological Studies-Depression scale (CES-D) before starting the study drug (between 11 and 20 weeks of gestation), between 32 and 38 weeks of gestation, and at 1 year postpartum. The primary outcome was maternal depressive symptoms score as assessed using the CES-D. Secondary outcome was the percentage of women who scored 16 or higher on the CES-D, as such a score is considered screen-positive for depression. Results Two hundred forty-five (36.2% of parent trial) women with subclinical hypothyroidism were allocated to thyroxine (n=124) or placebo (n=121). Median CES-D scores and the proportion of participants with positive scores were similar at baseline between the two groups. Treatment with thyroxine was not associated with differences in CES-D scores (10 [5-15] vs 10 [5-17]; P=.46) or in odds of screening positive in the third trimester compared with placebo, even after adjusting for baseline scores (24.3% vs 30.1%, adjusted odds ratio 0.63, 95% CI 0.31-1.28, P=.20). At 1 year postpartum, CES-D scores were not different (6 [3-11] vs 6 [3-12]; P=.79), nor was the frequency of screen-positive CES-D scores in the treated compared with the placebo group (9.7% vs 15.8%; P=.19). Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores. Sensitivity analysis including women who were diagnosed with depression by the postpartum visit did not change the results. Conclusions This study did not achieve its planned sample size, thus our conclusions may be limited, but in this cohort of pregnant women with subclinical hypothyroidism, antenatal thyroxine replacement did not improve maternal depressive symptoms.

Despite current guidelines recommending universal vaccination, the frequency of vaccination in pregnancy for influenza and tetanus-diphtheria-acellular pertussis remains low.This study aimed to evaluate the association between community-level social vulnerability and influenza and anticipated tetanus-diphtheria-acellular pertussis vaccinations among pregnant and postpartum individuals.We conducted a cross-sectional survey of vaccine hesitancy in the peripartum period among pregnant and postpartum participants enrolled in prenatal care at a single tertiary care center from March 22, 2021, to April 02, 2021. Participant addresses were geocoded using ArcGIS and linked at the census tract level. The primary exposure was community-level social vulnerability as measured by the US Centers for Disease Control and Prevention's Social Vulnerability Index. This index incorporates 15 census variables to produce a composite score and subscores across 4 major thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). The scores range from 0 to 1, with higher values indicating greater social vulnerability. The primary outcomes were self-reported influenza vaccination during the current influenza season and having received or planning to receive the tetanus-diphtheria-acellular pertussis vaccination in pregnancy. We used multivariable logistic regression and adjusted for age, self-reported race and ethnicity, parity, trimester of pregnancy, and chronic comorbid conditions.Of 456 assessed individuals (95% pregnant individuals and 5% postpartum individuals), the frequency of influenza vaccination was 58% (95% confidence interval, 53-62), and the anticipated tetanus-diphtheria-acellular pertussis vaccination was 72% (95% confidence interval, 68-76). Individuals from communities with a higher Social Vulnerability Index were less likely to report vaccination in pregnancy than those from communities with a lower Social Vulnerability Index. Specifically, for each 0.1-unit increase in the Social Vulnerability Index, the odds of influenza vaccination (adjusted odds ratio, 0.23; 95% confidence interval, 0.11-0.46) and anticipated tetanus-diphtheria-acellular pertussis vaccination (adjusted odds ratio, 0.24; 95% confidence interval, 0.11-0.53) decreased by70%. By domain, the Social Vulnerability Index subscores of socioeconomic status (influenza adjusted odds ratio, 0.20 [95% confidence interval, 0.10-0.40]; tetanus-diphtheria-acellular pertussis adjusted odds ratio, 0.25 [95% confidence interval, 0.12-0.53]) and housing type and transportation (influenza adjusted odds ratio, 0.41 [95% confidence interval, 0.19-0.84; tetanus-diphtheria-acellular pertussis adjusted odds ratio, 0.39 [95% confidence interval, 0.18-0.87) were inversely associated with a lower odds of influenza and tetanus-diphtheria-acellular pertussis vaccinations.Pregnant and postpartum individuals living in areas with higher social vulnerability were less likely to report influenza and anticipated tetanus-diphtheria-acellular pertussis vaccinations in pregnancy. The Social Vulnerability Index could be used as a tool to improve vaccine equity and address disparities in vaccination in pregnancy.

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

Managing pregnant individuals with acute respiratory disease secondary to Coronavirus disease 2019 has been a challenge. Most professional societies including the Society for Maternal Fetal Medicine recommend keeping oxygen saturation greater than or equal to 95% in pregnant individuals. Reaching this target has been increasingly difficult in some patients, especially with the latest wave of the virus attributed to the delta variant. In the absence of strong data, and in the setting of reassuring fetal status, we propose maintaining maternal oxygen saturation between 92-96% for admitted patients with acute respiratory failure requiring supplemental oxygen. This may prevent unnecessary invasive interventions that might not be of maternal or fetal benefit, specifically at very preterm gestational ages.

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 (n = 458) and an observational cohort of participants with abnormal 1-hour glucose loading test only (normal OGTT, n = 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

In modern obstetric practice, providers will encounter patients for whom opioid use in pregnancy is reasonable or even necessary. A "one-size-fits-all" approach to the counseling and management of such patients is misguided. Understanding indications for ongoing opioid use in pregnancy is essential to patient-centered care. Specifically, recognition of the nuanced differences between opioid dependence and opioid use disorder is crucial for appropriate diagnosis, screening for common concurrent conditions, adequately counseling about individualized maternal and perinatal risks, and accurate documentation of diagnoses and medical decision-making. In this paper, we explore the current typical scenarios in which opioid use in pregnancy may be encountered, ongoing opioid prescribing should be considered, and provide a guide for the obstetric provider to navigate the antepartum, intrapartum, and postpartum periods. KEY POINTS: · Opioid use in pregnant and postpartum individuals is not rare.. · Obstetric providers may elect to assume opioid prescribing.. · Obstetric providers are positioned to optimize outcomes for the mother-infant dyad..

OBJECTIVE To define patterns of prescription and factors associated with choice of pharmacotherapy for gestational diabetes mellitus (GDM), namely metformin, glyburide and insulin, during a period of evolving professional guidelines. DESING Cross-sectional study. SETTING US commercial insurance beneficiaries from Market-Scan (late 2015 to 2018). STUDY DESIGN We included women with GDM, singleton gestations, 15-51 years of age on pharmacotherapy. The exposure was pharmacy claims for metformin, glyburide and insulin. MAIN OUTCOMES Pharmacotherapy for GDM with either oral agent, metformin or glyburide, compared with insulin as the reference, and secondarily, consequent treatment modification (addition and/or change) to metformin, glyburide or insulin. RESULTS Among 37 762 women with GDM, we analysed data from 10 407 (28%) with pharmacotherapy, 21% with metformin (n = 2147), 48% with glyburide (n = 4984) and 31% with insulin (n = 3276). From late 2015 to 2018, metformin use increased from 17 to 29%, as did insulin use from 26 to 44%, whereas glyburide use decreased from 58 to 27%. By 2018, insulin was the most common pharmacotherapy for GDM; metformin was more likely to be prescribed by 9% compared with late 2015/16, but glyburide was less likely by 45%. Treatment modification occurred in 20% of women prescribed metformin compared with 2% with insulin and 8% with glyburide. CONCLUSIONS Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for GDM among a privately insured US population during a time of evolving professional guidelines. Further evaluation of the relative effectiveness and safety of metformin compared with insulin is needed. TWEETABLE ABSTRACT Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for gestational diabetes mellitus in the USA.

Problem Limited data exists on the temporal trend of the Sars‐CoV‐2 immunologic response and duration of protection following natural infection. We sought to investigate the presence and duration of Sars‐CoV‐2 serum antibodies in obstetrical healthcare workers (HCW) on serial assessments over a 6‐month period, and to assess rates of vaccine acceptance and reported vaccine side effects among this cohort. Method of study A prospective cohort study of a convenience sample of obstetrical HCWs at a tertiary hospital. Serum Sars‐CoV‐2 antibodies for Immunoglobulin G (IgG) and Immunoglobulin M (IgM) were measured longitudinally at four intervals: baseline, 4 weeks, 12 weeks, and 6 months. Participants completed voluntary surveys on COVID19 testing, high‐risk exposures, vaccine acceptance, and vaccine side effects. Results One hundred twenty‐six of 150 (84%) HCWs who volunteered for participation completed all four blood draws. Prevalence of seropositive HCWs based on positive Sars‐CoV‐2 IgG antibodies increased from 2% at baseline to 31% at 12 weeks but declined to 21% by 6 months. Forty‐two percent (19/43) of the participants considered seropositive for Sars‐CoV‐2 IgG antibodies at any of the initial three blood draws converted to seronegative status at the 6‐month follow‐up. Eighty‐seven percent (72/83) of participants who responded to a follow‐up survey were willing to accept the COVID19 vaccine. Rates of acceptance did not differ by participant antibody status. Those that experienced symptoms with the first injection were more likely to have positive Sars‐CoV‐2 IgG antibodies (36.8% vs. 9.6%, p = .01). Conclusion Sars‐CoV‐2 IgG antibodies wane over time and may not provide prolonged and robust immune protection. This underscores the importance of vaccination and continued research in this area while the COVID19 pandemic continues.

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