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Background: Preterm prelabor rupture of membranes before or around the limit of fetal viability is associated with serious maternal and neonatal complications, including chorioamnionitis, extremely preterm birth, and pulmonary hypoplasia., Objective: This study aimed to describe the contemporary outcomes of extremely preterm infants born after prolonged periviable preterm prelabor rupture of membranes and to identify perinatal factors associated with survival and survival without severe neurodevelopmental impairment., Study Design: Among actively treated infants born alive at <27 weeks' gestational age in centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network from 2012 to 2018, the outcomes of survival and survival without severe neurodevelopmental impairment at 22 to 26 months' corrected age were compared between infants exposed to prolonged (≥120 hours) periviable (<24 weeks' gestational age) preterm prelabor rupture of membranes and unexposed infants born after rupture of membranes ≤18 hours before delivery or at delivery with adjustment for birth gestational age, sex, multiple gestation, antenatal steroids, small for gestational age, insurance, and center. Regression models were used to identify perinatal factors associated with survival and survival without severe neurodevelopmental impairment among the infants exposed to prolonged periviable preterm prelabor rupture of membranes., Results: The analysis included 609 infants exposed to prolonged periviable preterm prelabor rupture of membranes and 4489 unexposed infants. In the prolonged periviable preterm prelabor rupture of membranes group, 444 of 608 (73%) infants survived and 298 of 533 (56%) infants survived without severe neurodevelopmental impairment. The odds of survival (odds ratio, 0.84; 95% confidence interval, 0.68-1.05) and survival without severe neurodevelopmental impairment (odds ratio, 0.91; 95% confidence interval, 0.75-1.12) were not significantly different between prolonged periviable preterm prelabor rupture of membranes and unexposed groups. The variables associated with higher odds of survival without severe neurodevelopmental impairment were later gestational age at birth (odds ratio, 1.37; 95% confidence interval, 1.13-1.67), later gestational age at preterm prelabor rupture of membranes (odds ratio, 1.44; 95% confidence interval, 1.26-1.63), and female sex (odds ratio, 1.57; 95% confidence interval, 1.06-2.34), whereas small-for-gestational-age infants had lower odds of survival without severe neurodevelopmental impairment (odds ratio, 0.14; 95% confidence interval, 0.04-0.51)., Conclusion: The odds of survival and survival without severe neurodevelopmental impairment among infants exposed to prolonged periviable preterm prelabor rupture of membranes were not significantly different from those of unexposed infants but decreased with earlier gestational age at birth and rupture of membranes., (Copyright © 2025 Elsevier Inc. All rights reserved.)

Objective:  This study aimed to test the hypothesis that being pregnant and delivering during the coronavirus disease 2019 (COVID-19) pandemic was associated with changes in gestational weight gain (GWG) or frequency of small- (SGA) or large-for-gestational-age (LGA) neonates., Study Design:  Secondary analysis of a multicenter observational cohort comparing pregnant people who delivered during the COVID-19 pandemic (June-December 2020) to people who delivered prior to the pandemic (March-December 2019). Those with multiple gestations, fetuses with major congenital anomalies, implausible GWG values, unavailable body mass index (BMI), or who were severe acute respiratory syndrome coronavirus-2-positive were excluded. The primary outcome was frequency of optimal recommended GWG based on prepregnancy BMI. Neonatal outcomes included birth weight, ponderal index, and frequency of SGA, LGA, and small head circumference for live births. Multivariable regression analysis was used to assess associations between exposure to the pandemic and outcomes., Results:  A total of 10,717 pregnant people were included in our analysis. A total of 4,225 pregnant people were exposed to the pandemic and 6,492 pregnant people delivered prior to the COVID-19 pandemic. Pregnant people exposed to the pandemic were older and more likely to have gestational diabetes. The frequency of appropriate GWG was 28.0% during the pandemic and 27.6% before the pandemic (adjusted odds ratio [aOR]: 1.02, 95% confidence interval [CI]: 0.93-1.11). Excessive GWG was more likely (54.9 vs. 53.1%; aOR: 1.08, 95% CI: 1.001-1.17), and inadequate GWG was less likely during the pandemic (17.0 vs. 19.3%; aOR: 0.86, 95% CI: 0.77-0.95). The frequency of SGA was 5.4% during the pandemic and 6.1% before the pandemic (aOR: 0.90, 95% CI: 0.76-1.06), and the frequency of LGA was 16.0% during the pandemic versus 15.0% before the pandemic (aOR: 1.06, 95% CI: 0.95-1.18). Other neonatal outcomes including birth weight percentile (62.1 [35.8-83.2] vs. 60.2 [34.4-82.2]; adjusted mean difference (aMD) = 1.50, 95% CI: -0.28 to 3.29), ponderal index (2.6 g/cm 3 [2.4-2.8] in both groups; aMD = 0.01, 95% CI: 0.00-0.02), and small head circumference for livebirths (<10th percentile [8.2 vs. 8.1%; aOR: 1.03, 95% CI: 0.89-1.19], <3rd percentile [3.5 vs. 3.1%; aOR: 1.16, 95% CI: 0.93-1.44]) were similar between groups as well., Conclusion:  Being pregnant and delivering during the COVID-19 pandemic was associated with a higher likelihood of excessive GWG and a lower likelihood of inadequate GWG., Key Points: · Delivering during the COVID-19 pandemic was associated with higher likelihood of excessive GWG.. · Delivering during the COVID-19 pandemic was associated with lower likelihood of inadequate GWG.. · COVID-19 pandemic was not associated with changes in frequency of SGA or LGA.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: To test whether treatment of mild chronic hypertension (CHTN) in pregnancy is associated with lower rates of unplanned maternal healthcare utilization postpartum., Methods: This was a secondary analysis of the CHTN and pregnancy study, a prospective, open-label, pragmatic, multicenter, randomized treatment trial of pregnant people with mild CHTN. All patients with a postpartum follow-up assessment were included. The primary outcome was unplanned healthcare utilization, defined as unplanned postpartum clinic visits, Emergency Department (ED) or triage visits, or unplanned hospital admissions within 6 weeks postpartum. Differences in outcomes were compared between study groups (Active Group: blood pressure goal of<140/90 mm Hg, and Control Group: blood pressure goal of <160/105 mm Hg), and factors associated with outcomes were examined using logistic regression., Results: A total of 2293 patients were included with 1157 (50.5%) in the active group and 1136 (49.5%) in the control group. Rates of unplanned maternal postpartum healthcare utilization did not differ between treatment and control groups, (20.2% vs 23.3%, P=.07, aOR 0.84, 95% CI 0.69-1.03). However, ED or triage/maternity evaluation unit visits were significantly lower in the Active group (10.2% vs 13.2%, P=.03, aOR 0.76, 95% 0.58-0.99). Higher BMI at enrollment and cesarean delivery were associated with higher odds of unplanned postpartum healthcare utilization., Conclusion: While treatment of mild CHTN during pregnancy and postpartum was not significantly associated with overall unplanned healthcare resource utilization, it was associated with lower rates of postpartum ED and triage visits., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective:  This study aimed to develop a prediction model that estimates the probability that a pregnant person who has had asymptomatic or mild coronavirus disease 2019 (COVID-19) prior to delivery admission will progress in severity to moderate, severe, or critical COVID-19., Study Design:  This was a secondary analysis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients who delivered from March through December 2020 at hospitals across the United States. Those eligible for this analysis presented for delivery with a current or previous asymptomatic or mild SARS-CoV-2 infection. The primary outcome was moderate, severe, or critical COVID-19 during the delivery admission through 42 days postpartum. The prediction model was developed and internally validated using stratified cross-validation with stepwise backward elimination, incorporating only variables that were known on the day of hospital admission., Results:  Of the 2,818 patients included, 26 (0.9%; 95% confidence interval [CI], 0.6-1.3%) developed moderate-severe-critical COVID-19 during the study period. Variables in the prediction model were gestational age at delivery admission (adjusted odds ratio [aOR], 1.15; 95% CI, 1.08-1.22 per 1-week decrease), a hypertensive disorder in a prior pregnancy (aOR 3.05; 95% CI, 1.25-7.46), and systolic blood pressure at admission (aOR, 1.04; 95% CI, 1.02-1.05 per mm Hg increase). This model yielded an area under the receiver operating characteristic curve of 0.82 (95% CI, 0.72-0.91)., Conclusion:  Among individuals presenting for delivery who had asymptomatic-mild COVID-19, gestational age at delivery admission, a hypertensive disorder in a prior pregnancy, and systolic blood pressure at admission were predictive of delivering with moderate, severe, or critical COVID-19. This prediction model may be a useful tool to optimize resources for SARS-CoV-2-infected pregnant individuals admitted for delivery., Key Points: · Three factors were associated with delivery with more severe COVID-19.. · The developed model yielded an area under the receiver operating characteristic curve of 0.82 and model fit was good.. · The model may be useful tool for SARS-CoV-2 infected pregnancies admitted for delivery.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: To evaluate the risks of adverse maternal and neonatal outcomes associated with pregnancies complicated by hepatitis C virus (HCV) infection., Methods: This is a secondary analysis of a multicenter prospective cohort study of HCV infection in pregnancy. Participants were screened for HCV infection with serum antibody tests, and each participant with a positive HCV result (case group) was matched with up to two individuals with negative HCV results (control group) prospectively by gestational age (±2 weeks) at enrollment. Maternal outcomes included gestational diabetes, abruption, preeclampsia or gestational hypertension, cholestasis, and preterm delivery. Neonatal outcomes included hyperbilirubinemia, admission to neonatal intensive care (NICU); small-for-gestational-age (SGA) birth weight; and neonatal infection , defined as sepsis or pneumonia. Models were adjusted for maternal age, body mass index, injection drug use, and maternal medical comorbidities., Results: The 249 individuals in the case group were prospectively matched to 486 individuals in the control group who met eligibility criteria. There were significant differences in demographic characteristics between the groups, including race, socioeconomic markers, education, insurance status, and drug and tobacco use. The frequencies of maternal outcomes of gestational diabetes, preeclampsia, and abruption were similar between the case and control groups. Preterm birth was similar between groups, but neonates born to individuals in the case group were more likely to be admitted to the NICU (45.1% vs 19.0%, adjusted odds ratio [aOR] 2.6, 95% CI, 1.8-3.8) and to have SGA birth weights below the 5th percentile (10.6% vs 3.1%, aOR 2.9, 95% CI, 1.4-6.0). There were no increased odds of hyperbilirubinemia or neonatal infection., Conclusion: Despite no increased odds of preterm birth or other adverse maternal outcomes in adjusted analyses, maternal HCV infection was associated with twofold increased odds of NICU admission and nearly threefold increased odds of SGA birth weight below the 5th percentile., Competing Interests: Financial Disclosure Brenna Hughes reports an ongoing financial relationship with UpToDate. Rebecca Clifton reports funding from the University of Arkansas for Medical Sciences for DSMB meetings and from the NIH to her institution. Anna Bartholomew reports money paid to her institution by NICHD and George Washington University. Alan Tita reports money paid to his institution from Pfizer. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Money was paid to her institution from Pfizer (site PI for phase III respiratory syncytial virus [RSV] vaccine trial and site PI for a COVID-19 vaccination trial in pregnancy). Geeta Swamy reports receiving past funding from GlaxoSmithKline and ongoing funding from Pfizer, Medscape, UpToDate, Moderna, and Sanofi. The other authors did not disclose any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: The Chronic Hypertension and Pregnancy Study demonstrated that a target blood pressure of <140/90 mm Hg during pregnancy is associated with improved perinatal outcomes. Outside of pregnancy, pharmacologic therapy for patients with diabetes and hypertension is adjusted to a target blood pressure of <130/80 mm Hg. During pregnancy, patients with both diabetes and chronic hypertension may also benefit from tighter control with a target blood pressure <130/80 mm Hg., Objective: We compared perinatal outcomes in patients with hypertension and diabetes who achieved blood pressure <130/80 vs 130 to 139/80 to 89 mm Hg., Study Design: This was a secondary analysis of a multcenter randomized controlled trial. Participants were included in this secondary analysis if they had diabetes diagnosed prior to pregnancy or at <20 weeks of gestation and at least 2 recorded blood pressure measurements prior to delivery. Average systolic and diastolic blood pressure were calculated using ambulatory antenatal blood pressures. The primary composite outcome was preeclampsia with severe features, indicated preterm birth <35 weeks, or placental abruption. Secondary outcomes were components of the primary outcome, cesarean delivery, fetal or neonatal death, neonatal intensive care unit admission, and small for gestational age. Comparisons were made between those with an average systolic blood pressure <130 mm Hg and average diastolic blood pressure <80 mm Hg and those with an average systolic blood pressure 130 to 139 mm Hg or diastolic blood pressure 80 to 89 mm Hg using Student's t test and chi-squared tests. Multivariable log-binomial regression models were used to evaluate risk ratios between blood pressure groups for dichotomous outcomes while accounting for baseline covariates., Results: Of 434 participants included, 150 (34.6%) had an average blood pressure less than 130/80 mm Hg. Participants with an average blood pressure less than 130/80 were more likely to be on antihypertensive medications at the start of pregnancy and more likely to have newly diagnosed diabetes mellitus prior to 20 weeks. Participants with an average blood pressure less than 130/80 mm Hg were less likely to have the primary adverse perinatal outcome (19.3% vs 46.5%, adjusted relative risk 0.43, 95% confidence interval 0.30-0.61, P<.01), with decreased risks specifically of preeclampsia with severe features (adjusted relative risk 0.35, 95% confidence interval 0.23-0.54) and indicated preterm birth prior to 35 weeks (adjusted relative risk 0.44, 95% confidence interval 0.24-0.79). The risk of neonatal intensive care unit admission was lower in the lower blood pressure group (adjusted relative risk 0.74, 95% confidence interval 0.59-0.94). No differences were noted in cesarean delivery (adjusted relative risk 1.04, 95% confidence interval 0.90-1.20), fetal or neonatal death (adjusted relative risk 0.59, 95% confidence interval 0.12-2.92). Small for gestational age less than the 10th percentile was lower in the lower blood pressure group (adjusted relative risk 0.37, 95% confidence interval 0.14-0.96)., Conclusion: In those with chronic hypertension and diabetes prior to 20 weeks, achieving an average goal blood pressure of <130/80 mm Hg may be associated with improved perinatal outcomes., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To investigate the optimal gestational age to deliver pregnant people with chronic hypertension to improve perinatal outcomes., Methods: We conducted a planned secondary analysis of a randomized controlled trial of chronic hypertension treatment to different blood pressure goals. Participants with term, singleton gestations were included. Those with fetal anomalies and those with a diagnosis of preeclampsia before 37 weeks of gestation were excluded. The primary maternal composite outcome included death, serious morbidity (heart failure, stroke, encephalopathy, myocardial infarction, pulmonary edema, intensive care unit admission, intubation, renal failure), preeclampsia with severe features, hemorrhage requiring blood transfusion, or abruption. The primary neonatal outcome included fetal or neonatal death, respiratory support beyond oxygen mask, Apgar score less than 3 at 5 minutes, neonatal seizures, or suspected sepsis. Secondary outcomes included intrapartum cesarean birth, length of stay, neonatal intensive care unit admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn, and hypoglycemia. Those with a planned delivery were compared with those expectantly managed at each gestational week. Adjusted odds ratios (aORs) with 95% CIs are reported., Results: We included 1,417 participants with mild chronic hypertension; 305 (21.5%) with a new diagnosis in pregnancy and 1,112 (78.5%) with known preexisting hypertension. Groups differed by body mass index (BMI) and preexisting diabetes. In adjusted models, there was no association between planned delivery and the primary maternal or neonatal composite outcome in any gestational age week compared with expectant management. Planned delivery at 37 weeks of gestation was associated with RDS (7.9% vs 3.0%, aOR 2.70, 95% CI, 1.40-5.22), and planned delivery at 37 and 38 weeks was associated with neonatal hypoglycemia (19.4% vs 10.7%, aOR 1.97, 95% CI, 1.27-3.08 in week 37; 14.4% vs 7.7%, aOR 1.82, 95% CI, 1.06-3.10 in week 38)., Conclusion: Planned delivery in the early-term period compared with expectant management was not associated with a reduction in adverse maternal outcomes. However, it was associated with increased odds of some neonatal complications. Delivery timing for individuals with mild chronic hypertension should weigh maternal and neonatal outcomes in each gestational week but may be optimized by delivery at 39 weeks., Competing Interests: Financial Disclosure: Torri D. Metz reports personal fees from Pfizer for her role as a medical consultant for a SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for SARS-CoV-2 vaccination in pregnancy study, and grants from Pfizer for role as a site PI for RSV vaccination in pregnancy study outside the submitted work. Sherri Longo reports that UAB received NIH funding for the CHAP trial and Ochsner was one of the sites participating in the trial. Ochsner received a subaward from UAB for participation in the trial. Ochsner is a subsite to UAB, who is in the MFMU network; therefore, they have participated in trials. They have participated in other studies with UAB, including the CSOAP trial. They have collaborated on studies with Tulane and have subawards. Kelly Gibson reports money was paid to her institution from NHLBI, NICHD, and Materna Medical. Lauren Plante reports receiving payment from Cambridge University Press and Taylor & Francis for textbook royalties. She also received an honorarium speaking fee from Monmouth Medical Center. Sean Esplin received payment from Laborie and Nemo Health. Heather Frey and Wendy Kinzler received payment from UpToDate. Todd Rosen's institution received payment from Materna, Inc. and Myriad, Inc. Mary Norton received payment from Luna Genetics. Daniel Skupski received payment from Organon and Cooper Surgical. Leonardo Pereira's institution received payment for a Johnson & Johnson clinical trial. He received payment from Prehevbrio for serving on the data safety monitoring board for hepatitis vaccine in pregnancy. Namasivayam Ambalavanan received payment from Oak Hill Bio and for serving on the advisory board and holding intellectual property with AlveolusBio and Resbiotic. Alan T. N. Tita's institution received payment from Pfizer. Everett Magann received payment from UpToDate for co-authorship of the Ultrasound Assessment of Amniotic Fluid Volume chapter. Lorraine Dugoff reports that money was paid to her institution from Myriad and Natera. Brenna L. Hughes reports receiving funding from UpToDate and Moderna. Eugene Chang reports money was paid to his institution from Roche Diagnostics and Roche. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors., Methods: In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC., Results: Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9-10.9%) measured at a median of 10.3 months (interquartile range 6.1-21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12-2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79-3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05-2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00-3.44) were associated with increased prevalence of PASC., Conclusion: The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy., Clinical Trial Registration: ClinicalTrials.gov , NCT05172024., Competing Interests: Financial Disclosure Torri D. Metz is the site PI for a Pfizer study of Paxlovid in pregnancy and was the site PI for a Pfizer study of COVID-19 vaccination in pregnancy. She has received UpToDate royalties for two topics on trial of labor after cesarean. Carmen J. Beamon disclosed receiving payments from Wellcare of North Carolina. Ann Chang's institution received payment from New York University for her efforts on this study. Kelly S. Gibson disclosed that her institution received funding from the NICHD, NHLBI, and Materna. Rachel Hess received payment from Astellas Pharmaceuticals. M. Camile Hoffman disclosed her institution received payment for her expert testimony for one medicolegal trial from Wheeler, Trigg, and Associates (a defense attorneys firm). Her institution also received payment for a disease state presentation on postpartum depression and zuranolone from SAGE/Biogen. Brenna L. Hughes disclosed receiving payments from UpToDate and Moderna. Stuart Katz disclosed payments for providing expert testimony for Venable LLP. Jennifer Hadlock has received funding (paid to institution) for retrospective studies of COVID-19 from Pfizer, Novartis, Janssen, and Gilead. Grace A. McComsey served as an advisor for Gilead and ViiVGlaxoSmithKline. Patrick Ramsey disclosed receiving royalties from UpToDate. His institution was paid by the Texas Collaborative for Healthy Mothers and Babies (TCHMB)—Texas PQC for part of his efforts. Daniel W. Skupski reports receiving payments from Organon, Inc and Cooper Surgical. Alan T.N. Tita disclosed money paid to his institution from Pfizer for his efforts in this study. Andrea Foulkes disclosed receiving past payments from Round Table, Inc. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Prior studies have shown that maternal deaths due to sepsis occur due to delays in recognition, treatment, and escalation of care through medical chart reviews. This study was conducted to obtain the patient perspective for near-miss and maternal mortality cases due to sepsis., Objective: To identify quality improvement opportunities for improving maternal sepsis through patient and support person experiences., Study Design: Twenty semi-structured interviews and three follow-up focus groups with patients who experienced critical illness from maternal sepsis in the United States and their support persons (when available) were conducted from May 23, 2022, through October 14, 2022. In this qualitative study, data were analyzed using inductive thematic analysis., Results: In this qualitative study of patients with maternal sepsis and their support persons, four main quality improvement themes were identified. The themes were the following: (1) participants reported a lack of awareness of pregnancy-related warning signs and symptoms of when to seek care, (2) many of the presenting symptoms participants experienced were not typical of expected warning signs of maternal sepsis, such as severe pain, overwhelming tiredness, and lack of fever (3) participant concerns were met with dismissal leading to delays in diagnosis, (4) participants experienced long-term sequelae but had difficulty receiving screening and referrals for treatment., Conclusions: The findings of this study suggest that standardized patient education about the warning signs of maternal sepsis and provider education about the presentation of maternal sepsis, improved listening to patients, and follow-up for sequalae of sepsis are needed., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objective: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial., Methods: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated., Results: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations., Conclusion: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits., Clinical Trial Registration: ClinicalTrials.gov , NCT02299414., Competing Interests: Financial Disclosure Rodney K. Edwards' institution received grants from the Oklahoma Center for Advancement of Science and Technology for a pilot study related to postcesarean opioids, and from the NIH through Oklahoma CTR for a pilot trial on warming preterm infants during delayed cord clamping, a Presbyterian Health Foundation Team Science grant for a pilot trial evaluating effect of omega-3 fatty acid supplementation on maternal triglycerides and fetal growth, an NIH grant to evaluate changes in atherogenic apolipoproteins with immediate prepregnancy intervention and whether they were maintained during pregnancy, a grant from Cepheid for clinical evaluation of the Xpert Xpress GBS test using vaginal/rectal dual swabs collected intrapartum, and an NIH grant for a multicenter RCT evaluating intensive glycemic targets in overweight and obese women with GDM. He has a pending NIH grant for a multicenter RCT evaluating prophylactic antibiotics for inductions of labor in nulliparous women with obesity at term. Dr. Edwards served as an expert witness in a case regarding a malpractice claim. Kelly S. Gibson's institution received funding for the Materna Medical research study (EASE). She received payment from the NIH for serving on the RADX grant review committee. She has been a speaker at an ACOG-AIM webinar and received a Ohio State AIM grant for hypertension treatment. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Pfizer, as she has been a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial, a COVID-19 vaccine trial in pregnancy, and pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19 (institution received money to conduct studies). Sean Esplin received payment from Laborie. Anna Palatnik received payment from the American Heart Association career development award and from NHLBI HL165013 to evaluate intensive postpartum antihypertensive treatment following gestational hypertension or preeclampsia. Mary E. Norton received payment from Luna Genetics. Leonardo Pereira's institution received payment from Johnson & Johnson/Janssen pharmaceuticals to support a clinical trial in alloimmunized patients. Everett F. Magann received a royalty as an author of the UpToDate chapter on ultrasound estimate of amniotic fluid volume. Eugene Chang's institution received payment from Roche Diagnostics. Alan T.N. Tita's institution received payment from Pfizer. Sherri Longo acknowledges the financial support received for the Prospect study and other NIH-funded studies including CHAP maternal follow-up and CSOAP follow-up. She is also an investigator for the Moms on the Bayou research project with Tulane University and is receiving funding from the NIH Maternal Health Research Center of Excellence awarded to a collaborative effort between Tulane University, Ochsner Health, and RHI. Todd Rosen acknowledges the financial support received as a co-investigator from Materna Medical Inc to evaluate the safety and effectiveness of the Materna Prep Device; NEIHS/HIN for the Ambient Air Pollution, Weather, and Placental Abruption (APWA) study; NIH/NICHD for The Genomic Architecture of Pregnancy Loss study and Multicenter Maternal-Fetal Medicine Unit Research Network—MFMU Clinical Center (TAC); NIH/NHLBI for Pregnancy as a Window to the Future study (a CHAP maternal follow-up study) and for Cardiovascular Health After Placental Abruption study; and as a principal investigator for Sulfasalazine to Prevent Preterm Birth, funded by the Hudson Shea Foundation and The Perinatal Research Consortium. Daniel Skupski's institution received payment from Pfizer, as he served as a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial (institution received money to conduct study). His institution also received payment for her to serve as a site PI for a COVID-19 vaccination trial in pregnancy. Dr. Skupski is also a paid consultant for the Organon company in relation to a medical device (Fetal Pillow) used to manage cesarean deliveries performed during the second stage of labor. Rachel Sinkey received funding paid to her institution from the NIH and the American Heart Association. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial., Methods: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding., Results: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine., Conclusion: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy., Clinical Trial Registration: ClinicalTrials.gov, NCT02299414., Competing Interests: Financial Disclosure Brenna L. Hughes reports receiving payment from UpToDate. Rodney K. Edwards' institution received payment from the Oklahoma Center for Advancement of Science and Technology and the Presbyterian Health Foundation. He received payment from the NIH through Oklahoma CTR grant for a pilot trial on warming preterm infants during delayed cord clamping. He received a Presbyterian Health Foundation grant for a pilot trial on omega-3 fatty acid supplementation effects on maternal triglycerides and fetal growth. He received an NIH grant for evaluation of atherogenic lipoproteins changes with immediate prepregnancy intervention and whether they were maintained during pregnancy. He received a grant from Cepheid for the clinical evaluation of the Xpert Xpress GBS test using vaginal/rectal swabs collected intrapartum. He was awarded an Oklahoma State DOH contract for support for patient-centered, comprehensive pregnancy care for women with substance use disorders. He received an NIH grant for a multicenter RCT of intensive glycemic targets in women with overweight and obesity with GDM. Lastly, he has a pending NIH grant for a multicenter RCT of prophylactic antibiotics for induction of labor in women with obesity. He has served on an expert witness case regarding a medical malpractice claim. Kelly S. Gibson's institution received an NHCID-MFMU network grant and Materna Medical research support (EASE). She received payment from NIH as a RADx grant reviewer and was an Ohio AIM grant recipient as an AIM webinar speaker. Rachel Sinkey received funding paid to her institution from the NIH and the American Heart Association. Kelly S. Gibson reports her institution received an NHCID-MFMU network grant and Materna Medical research support (EASE). She received payment as a NIH-RADx grant reviewer. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Pfizer, as she has been a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial (institution received money to conduct study). Her institution also received payment for her to serve as a site PI for a COVID-19 vaccination trial in pregnancy. She has received payment from Pfizer as a site PI for a pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19. Sean Esplin received payment from Laborie. Mary E. Norton received payment from Luna Genetics. Daniel Skupski received payment from Organon and Cooper Surgical. Leonardo Pereira's institution received payment from Johnson & Johnson/Janssen Pharmaceuticals for an FDA trial on alloimmunization management. Everett F. Magann is a co-author on and UpToDate chapter on amniotic fluid volume assessment. Heather Frey also received royalties for contributions to UpToDate on the topic of uterine rupture. Alan T.N. Tita's institution received funding from Pfizer. Torri D. Metz received UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Pfizer, as she has been a site PI for a phase III respiratory syncytial virus (RSV) vaccine trial, a COVID-19 vaccine trial in pregnancy, and pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19 (institution received money to conduct studies). Kara K. Hoppe's institution received an NIH grant for a multicenter RCT of remote blood pressure monitoring with health coaching versus standard of care, HHS funding for a hypertension challenge initiative, Marani to study implementation of their remote patient monitoring platform for hypertensive patients in pregnancy and postpartum. Additionally, she received payment for the NIH as a grant reviewer and WisPQC for providing physician leadership for the state quality initiative on hypertension in pregnancy. Eugene Chang received payment from Roche diagnostics for research on sflt-1/plgf. Sherri Longo acknowledges the financial support received for the Prospect study and other NIH-funded studies including CHAP maternal follow-up and CSOAP follow-up. She is also an investigator for the Moms on the Bayou research project with Tulane University and is receiving funding from the NIH Maternal Health Research Center of Excellence awarded to a collaborative effort between Tulane University, Ochsner Health, and RHI. Alan T.N. Tita's institution received funding from Pfizer. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Recent data in nonpregnant individuals suggest a protective effect of influenza vaccination against SARS-CoV-2 infection and its severity., Objectives: Our primary objective was to evaluate whether influenza vaccination was associated with COVID-19 severity and pregnancy and neonatal outcomes among those infected with SARS-CoV-2. The secondary objective was to examine the association between influenza vaccination and SARS-CoV-2 infection., Study Design: Secondary analysis of a multicenter retrospective cohort of pregnant people who tested positive for SARS-CoV-2 between March and August 2020, and a cohort of random deliveries during the same time period. The associations between 2019 influenza vaccination and the primary outcome of moderate-to-critical COVID-19 as well as maternal and perinatal outcomes were examined among all people who tested positive for SARS-CoV-2 between March and August 2020. The association between 2019 influenza vaccination and having a positive SARS-CoV-2 test was examined among a cohort of individuals who delivered on randomly selected dates between March and August 2020. Univariable and multivariable analyses were performed., Results: Of 2325 people who tested positive for SARS-CoV-2, 1068 (45.9%) were vaccinated against influenza in 2019. Those who received the influenza vaccine were older, leaner, more likely to have private insurance, and identify as White or Hispanic. They were less likely to smoke tobacco and identify as Black. Overall, 419 (18.0%) had moderate, 193 (8.3%) severe, and 52 (2.2%) critical COVID-19. There was no association between influenza vaccination and moderate-to-critical COVID-19 (29.2% vs. 28.0%, adjusted OR 1.10, 95% CI 0.90-1.34) or adverse maternal and perinatal outcomes among those who tested positive. Of 8152 people who delivered in 2020, 4658 (57.1%) received the influenza vaccine. Prior vaccination was not associated with a difference in the odds of SARS-CoV-2 infection (3.8% vs. 4.2%, adjusted OR 0.94, 95% CI 0.74-1.19)., Conclusion: Prior influenza vaccination was not associated with decreased severity of COVID-19 or lower odds of SARS-CoV-2 infection in pregnancy., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Venous thromboembolism accounts for approximately 9% of pregnancy-related deaths in the United States. National guidelines recommend postpartum risk stratification and pharmacologic prophylaxis in at-risk individuals. Knowledge on modern rates of postpartum pharmacologic thromboprophylaxis and its associated risks is limited., Objective: This study aimed to describe the rate of, and factors associated with, initiation of postpartum pharmacologic prophylaxis for venous thromboembolism, and to assess associated adverse outcomes., Study Design: This was a secondary analysis of a multicenter cohort of individuals delivering on randomly selected days at 17 US hospitals (2019-2020). Medical records were reviewed by trained and certified personnel. Those with an antepartum diagnosis of venous thromboembolism, receiving antepartum anticoagulation, or known SARS-CoV-2 infection were excluded. The primary outcome was use of postpartum pharmacologic thromboprophylaxis. Secondary outcomes included bleeding complications, surgical site infection, hospital readmission, and venous thromboembolism through 6 weeks postpartum. The rate of thromboprophylaxis administration was assessed by mode of delivery, institution, and continuance to the outpatient setting. Multivariable regression models were developed using k-fold cross-validation with stepwise backward elimination to evaluate factors associated with thromboprophylaxis administration. Univariable and multivariable logistic models with propensity score covariate adjustment were performed to assess the association between thromboprophylaxis administration and adverse outcomes., Results: Of 21,114 individuals in the analytical cohort, 11.9% (95% confidence interval, 11.4%-12.3%) received postpartum pharmacologic thromboprophylaxis; the frequency of receipt was 29.8% (95% confidence interval, 28.7%-30.9%) following cesarean and 3.5% (95% confidence interval, 3.2%-3.8%) following vaginal delivery. Institutional rates of prophylaxis varied from 0.21% to 34.8%. Most individuals (83.3%) received thromboprophylaxis only as inpatients. In adjusted analysis, cesarean delivery (adjusted odds ratio, 19.17; 95% confidence interval, 16.70-22.00), hysterectomy (adjusted odds ratio, 15.70; 95% confidence interval, 4.35-56.65), and obesity (adjusted odds ratio, 3.45; 95% confidence interval, 3.02-3.95) were the strongest factors associated with thromboprophylaxis administration. Thromboprophylaxis administration was not associated with surgical site infection (0.9% vs 0.6%; odds ratio, 1.48; 95% confidence interval, 0.80-2.74), bleeding complications (0.2% vs 0.1%; odds ratio, 2.60; 95% confidence interval, 0.99-6.80), or postpartum readmission (0.9% vs 0.3%; adjusted odds ratio, 1.38; 95% confidence interval, 0.68-2.81). The overall rate of venous thromboembolism was 0.06% (95% confidence interval, 0.03%-0.10%) and was higher in those receiving prophylaxis (0.2%) compared with those not receiving prophylaxis (0.04%)., Conclusion: Approximately 1 in 10 patients received postpartum pharmacologic thromboprophylaxis in this US cohort. Rates of prophylaxis varied widely by institution. Cesarean delivery, hysterectomy, and obesity were predominant factors associated with postpartum thromboprophylaxis administration., (Copyright © 2023. Published by Elsevier Inc.)

Objective: To improve timely and equitable access to postpartum blood pressure (BP) monitoring in individuals with hypertensive disorders of pregnancy (HDP)., Methods: A quality improvement initiative was implemented at a large academic medical centre in the USA for postpartum individuals with HDP. The primary aim was to increase completed BP checks within 7 days of hospital discharge from 40% to 70% in people with HDP in 6 months. Secondary aims included improving rates of scheduled visits, completed visits within 3 days for severe HDP and unattended visits. The balancing measure was readmission rate. Statistical process control charts were used, and data were stratified by race and ethnicity. Direct feedback from birthing individuals was obtained through phone interviews with a focus on black birthing people after a racial disparity was noted in unattended visits., Results: Statistically significant improvements were noted across all measures. Completed and scheduled visits within 7 days of discharge improved from 40% to 76% and 61% to 90%, respectively. Completed visits within 3 days for individuals with severe HDP improved from 9% to 49%. The unattended visit rate was 26% at baseline with non-Hispanic black individuals 2.3 times more likely to experience an unattended visit than non-Hispanic white counterparts. The unattended visit rate decreased to 15% overall with an elimination of disparity. A need for BP devices at discharge and enhanced education for black individuals was identified through patient feedback., Conclusion: Timely follow-up of postpartum individuals with HDP is challenging and requires modification to our care delivery. A hospital-level quality improvement initiative using birthing individual and frontline feedback is illustrated to improve equitable, person-centred care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The COVID pandemic has been associated with varied effects on preterm birth (PTB). We sought to compare rates of PTB during the pre- and post vaccination COVID periods with pre-pandemic PTB rates, stratified by race and ethnicity., Study Design: Retrospective cohort comparing all deliveries over 20 weeks at a single tertiary center during "early" (March 2020-June 2020) versus "late" COVID (March 2021-June 2021), and "late" COVID versus pre-COVID (March to June 2014-2019). PTBs <37, <34, and <28 weeks were compared and stratified by race/ethnicity., Results: A total of 16,483 deliveries occurred including 2,068 "early" COVID, 2,115 "late" COVID, and 12,300 pre-COVID. The PTB rate during "late" COVID was lower compared to "early" COVID (12.1 vs. 14.6%, p  = 0.02). Rate of PTB <34 was also lower during "late" COVID (4.4 vs. 5.7%, p  = 0.05). PTB <28 did not differ. When controlling for prior PTB, "late" COVID remained associated with a decreased risk of PTB compared to "early" COVID, adjusted odds ratio (aOR) of 0.82 (95% confidence interval [CI]: 0.68, 0.98). Although there was no difference in PTB among Hispanic individuals when comparing "late" COVID versus pre-COVID, when further subdivided, a small number of Hispanic Puerto Rican individuals had higher odds of PTB < 37 during "late" COVID versus pre-COVID (aOR = 4.29 [95% CI: 1.12, 16.4]). Additionally, White individuals had reduced odds of PTB <37 (aOR = 0.80 [95% CI: 0.65, 0.98]) during "late" COVID versus pre-COVID while the PTB rate was unchanged when comparing "late" COVID versus pre-COVID in all other racial and ethnic groups., Conclusion: During 2021, PTB rates decreased from rates observed in 2020 at the height of COVID restrictions. Among White birthing individuals, PTB decreased in 2021 compared to pre-COVID rates. This decrease was not observed in Black and Hispanic birthing individuals. These data highlight the continued racially disparate impact of the COVID-19 pandemic on PTB rates., Key Points: · The COVID-19 pandemic has been associated with varied effects on the preterm birth (PTB) rate.. · PTB rates decreased in "late" COVID compared to "early" COVID.. · When stratified, PTB decreased among white individuals, but not in Black or Hispanic individuals.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objectives: The objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction., Materials and Methods: Secondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8 kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine >5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure ( p  < 0.05) in univariate analysis., Results: Of 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55-4.20), but the difference was not significantly different (adjusted odds ratio [aOR] = 1.0, 95% CI 0.30-3.31). This association was similar when exposure was stratified as heavy (>100 ng/mL, aOR 0.72, 95% CI 0.15-3.51) or mild (5-100 ng/mL, aOR 1.28, 95% CI 0.33-4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude., Conclusion: In a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs., Key Points: · Nicotine exposure was quantified from maternal urine.. · Nicotine exposure was identified in 30% of the cohort.. · Exposure was not associated with offspring hearing dysfunction.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: The use of extracorporeal membrane oxygenation (ECMO) therapy has increased in the adult population. Studies from the H1N1 influenza pandemic suggest that ECMO deployment in pregnancy is associated with favorable outcomes. With increasing numbers of pregnant women affected by COVID-19 (coronavirus disease 2019) and potentially requiring this life-saving therapy, we sought to compare comorbidities, costs, and outcomes between pregnancy- and nonpregnancy-associated ECMO therapy among reproductive-aged female patients., Study Design: We used the 2013 to 2019 National Readmissions Database. Diagnosis and procedural coding were used to identify ECMO deployment, potential indications, comorbid conditions, and pregnancy outcomes. The primary outcome was in-hospital mortality during the patient's initial ECMO stay. Secondary outcomes included length of stay and hospital charges/costs, occurrence of thromboembolic or bleeding complications during ECMO hospitalization, and mortality and readmissions up to 330 days following ECMO stay. Univariate and multivariate regression models were used to model the associations between pregnancy status and outcomes., Results: The sample included 324 pregnancy-associated hospitalizations and 3,805 nonpregnancy-associated hospitalizations, corresponding to national estimates of 665 and 7,653 over the study period, respectively. Pregnancy-associated ECMO had lower incidence of in-hospital death (adjusted odds ratio [aOR]: 0.56, 95% confidence interval [CI]: 0.41-0.75) and bleeding complications (aOR: 0.67, 95% CI: 0.49-0.93). Length of stay was significantly shorter (adjusted rate ratio (aRR): 0.86, 95% CI: 0.77-0.96) and total hospital costs were less (aRR: 0.83, 95% CI: 0.75-0.93). Differences in the incidence of thromboembolic events (aOR: 1.04, 95% CI: 0.78-1.38) were not statistically significant., Conclusion: Pregnancy-associated ECMO therapy had lower incidence of in-hospital death, bleeding complications, total inpatient cost, and length of stay when compared with nonpregnancy-associated ECMO therapy without increased thromboembolic complications. Pregnancy-associated ECMO therapy should be offered to eligible patients., Key Points: · Pregnancy-related ECMO use was compared with nonpregnant use.. · Outcomes were equal or favored pregnancy-related deployment.. · These data may be useful when considering ECMO use in pregnancy.., Competing Interests: J.J.F. is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number: UL1TR002553. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Data acquisition for this project was supported by grant funding for the Foundation for Women and Girls with Blood Disorders., (Thieme. All rights reserved.)

Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide with peak hospitalization rates for RSV-mediated illnesses between 2 and 3 months of life. Until very recently, prevention strategies for RSV involved primarily passive immunization of neonates at high risk with monoclonal antibodies and promotion of breastfeeding. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices now recommends passive immunization of all neonates with monoclonal antibodies during RSV season, and the American Association of Pediatrics has endorsed this practice. The U.S. Food and Drug Administration (FDA) recently approved a vaccination for RSV in pregnancy. The CDC's Advisory Committee on Immunization Practices has recently recommended RSV vaccination for all pregnant patients between 32 and 36 weeks of gestation who are anticipated to deliver during RSV season if they are not planning nirsevimab for their infants. This recommendation has been endorsed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. In this clinical perspective, we review the scientific evidence, potential concerns, challenges, and future considerations for RSV vaccination in pregnancy., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the performance characteristics of existing screening tools for the prediction of sepsis during antepartum and postpartum readmissions., Methods: This was a case-control study using electronic health record data obtained between 2016 and 2021 from 67 hospitals for antepartum sepsis admissions and 71 hospitals for postpartum readmissions up to 42 days. Patients in the sepsis case group were matched in a 1:4 ratio to a comparison cohort of patients without sepsis admitted antepartum or postpartum. The following screening criteria were evaluated: the CMQCC (California Maternal Quality Care Collaborative) initial sepsis screen, the non-pregnancy-adjusted SIRS (Systemic Inflammatory Response Syndrome), the MEWC (Maternal Early Warning Criteria), UKOSS (United Kingdom Obstetric Surveillance System) obstetric SIRS, and the MEWT (Maternal Early Warning Trigger Tool). Time periods were divided into early pregnancy (less than 20 weeks of gestation), more than 20 weeks of gestation, early postpartum (less than 3 days postpartum), and late postpartum through 42 days. False-positive screening rates, C-statistics, sensitivity, and specificity were reported for each overall screening tool and each individual criterion., Results: We identified 525 patients with sepsis during an antepartum hospitalization and 728 patients with sepsis during a postpartum readmission. For early pregnancy and more than 3 days postpartum, non-pregnancy-adjusted SIRS had the highest C-statistics (0.78 and 0.83, respectively). For more than 20 weeks of gestation and less than 3 days postpartum, the pregnancy-adjusted sepsis screening tools (CMQCC and UKOSS) had the highest C-statistics (0.87-0.94). The MEWC maintained the highest sensitivity rates during all time periods (81.9-94.4%) but also had the highest false-positive rates (30.4-63.9%). The pregnancy-adjusted sepsis screening tools (CMQCC, UKOSS) had the lowest false-positive rates in all time periods (3.9-10.1%). All tools had the lowest C-statistics in the periods of less than 20 weeks of gestation and more than 3 days postpartum., Conclusion: For admissions early in pregnancy and more than 3 days postpartum, non-pregnancy-adjusted sepsis screening tools performed better than pregnancy-adjusted tools. From 20 weeks of gestation through up to 3 days postpartum, using a pregnancy-adjusted sepsis screening tool increased sensitivity and minimized false-positive rates. The overall false-positive rate remained high., Competing Interests: Financial Disclosure Melissa Bauer disclosed receiving consulting fees from the Institute for Healthcare Innovation, and travel compensation from National AIM to present the ACOG/AIM Sepsis Bundle at the ACOG Annual Conference. Vesela Kovacheva disclosed receiving consulting fees from Avania CRO unrelated to the current study. Paloma Toledo disclosed receiving speaker fees from Pacira Biosciences, Inc. Kurt Wharton disclosed receiving consulting fees from Molnlycke. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the screening performance characteristics of existing tools for the diagnosis of sepsis during delivery admissions., Methods: This was a case-control study using electronic health record data, including vital signs and laboratory results, for all delivery admissions of patients with sepsis from 59 nationally distributed hospitals. Patients with sepsis were matched by gestational age at delivery in a 1:4 ratio with patients without sepsis to create a comparison group. Patients with chorioamnionitis and sepsis were compared with a complete cohort of patients with chorioamnionitis without sepsis. Multiple screening criteria for sepsis were evaluated: the CMQCC (California Maternal Quality Care Collaborative), SIRS (Systemic Inflammatory Response Syndrome), the MEWC (the Maternal Early Warning Criteria), UKOSS (United Kingdom Obstetric Surveillance System), and the MEWT (Maternal Early Warning Trigger Tool). Sensitivity, false-positive rates, and C-statistics were reported for each screening tool. Analyses were stratified into cohort 1, which excluded patients with chorioamnionitis-endometritis, and cohort 2, which included those patients., Results: Delivery admissions at 59 hospitals were extracted for patients with sepsis. Cohort 1 comprised 647 patients with sepsis, including 228 with end-organ injury, matched with a control group of 2,588 patients without sepsis. Cohort 2 comprised 14,591 patients with chorioamnionitis-endometritis, of whom 1,049 had sepsis and 238 had end-organ injury. In cohort 1, the CMQCC and the UKOSS pregnancy-adjusted criteria had the lowest false-positive rates (6.9% and 9.6%, respectively) and the highest C-statistics (0.92 and 0.91, respectively). Although other screening criteria, such as SIRS and the MEWC, had similar sensitivities, it was at the cost of much higher false-positive rates (21.3% and 38.3%, respectively). In cohort 2, including all patients with chorioamnionitis-endometritis, the highest C-statistics were again for the CMQCC (0.67) and UKOSS (0.64). All screening tools had high false-positive rates, but the false-positive rates for the CMQCC and UKOSS were substantially lower than those for SIRS and the MEWC., Conclusion: During delivery admissions, the CMQCC and UKOSS pregnancy-adjusted screening criteria have the lowest false-positive results while maintaining greater than 90% sensitivity rates. Performance of all screening tools was degraded in the setting of chorioamnionitis-endometritis., Competing Interests: Financial Disclosure Melissa Bauer reports consulting fees from Institute for Healthcare Innovation. Vesela. Kovacheva reports consulting fees from Avania CRO unrelated to the current work. Paloma Toledo reports speaker fees from Pacira Biosciences, Inc. Kurt Wharton receives consulting fees from Molnlycke. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To characterize breastfeeding behaviors and identify factors associated with breastfeeding initiation among people with hepatitis C virus (HCV) infection., Methods: We conducted a secondary analysis of a multicenter observational cohort of pregnant people with singleton gestations and HCV seropositivity. This analysis includes individuals with data on breastfeeding initiation and excludes those with human immunodeficiency virus (HIV) co-infection. The primary outcome was self-reported initiation of breastfeeding or provision of expressed breast milk. Secondary outcomes included duration of breastfeeding. Demographic and obstetric characteristics were compared between those who initiated breastfeeding and those who did not to identify associated factors. Univariable and multivariable analyses were performed., Results: Overall, 579 individuals (75.0% of participants in the parent study) were included. Of those, 362 (62.5%) initiated breastfeeding or provided breast milk to their infants, with a median duration of breastfeeding of 1.4 months (interquartile range 0.5-6.0). People with HCV viremia , defined as a detectable viral load at any point during pregnancy, were less likely to initiate breastfeeding than those who had an undetectable viral load (59.4 vs 71.9%, adjusted odds ratio [aOR] 0.61, 95% CI, 0.41-0.92). People with private insurance were more likely to initiate breastfeeding compared with those with public insurance or no insurance (80.0 vs 60.1%; aOR 2.43, 95% CI, 1.31-4.50)., Conclusion: Although HCV seropositivity is not a contraindication to breastfeeding regardless of viral load, rates of breastfeeding initiation were lower among people with HCV viremia than among those with an undetectable viral load., Clinical Trial Registration: ClinicalTrials.gov , NCT01959321 ., Competing Interests: Financial Disclosure Alan T.N. Tita reports money was paid to his institution from Pfizer. Torri D. Metz reports receiving royalties from UpToDate for two topics on trial of labor after cesarean delivery. Her institution received payment from Pfizer, when she was a site PI for Phase III respiratory syncytial virus (RSV) vaccine trial, and when she was a site PI for a pharmacokinetic study of Paxlovid in pregnancy for mild-to-moderate COVID-19. Geeta K Swamy reports receiving payment from GlaxoSmithKline, Pfizer, UpToDate, Sanofi, Medscape, and Moderna. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Respiratory syncytial virus is a leading cause of lower respiratory tract illness globally in children aged <5 years. Each year, approximately 58,000 hospitalizations in the United States are attributed to respiratory syncytial virus. Infants aged ≤6 months experience the most severe morbidity and mortality. Until recently, prevention with the monoclonal antibody, palivizumab, was only offered to infants with high-risk conditions, and treatment primarily consisted of supportive care. Currently, 2 products are approved for the prevention of respiratory syncytial virus in infants. These include the Pfizer bivalent recombinant respiratory syncytial virus prefusion F protein subunit vaccine, administered seasonally to the pregnant person between 32 0/7 and 36 6/7 weeks of gestation, and the monoclonal antibody, nirsevimab, administered to infants aged up to 8 months entering their first respiratory syncytial virus season. With few exceptions, administering both the vaccine to the pregnant person and the monoclonal antibody to the infant is not recommended. All infants should be protected against respiratory syncytial virus using one of these strategies. Key considerations for pregnant individuals include examining available safety and efficacy data, weighing accessibility and availability, and patient preferences for maternal vaccination vs infant monoclonal antibody treatment. It will be critical for maternal-fetal medicine physicians to provide effective and balanced counseling to aid patients in deciding on a personalized approach to the prevention of respiratory syncytial virus in their infants., (Copyright © 2023. Published by Elsevier Inc.)

Objective: Pyelonephritis is the most common nonobstetric cause for hospitalization during pregnancy. The maternal and obstetric complications associated with antepartum pyelonephritis are well described. However, it is not clear whether these risks extend into the postpartum period. The primary objective of this study was to describe the morbidity associated with postpartum pyelonephritis, by comparing the morbidity associated with pyelonephritis in the postpartum period to morbidity seen during pregnancy or delivery., Study Design: A retrospective cohort study was performed using the Nationwide Readmissions Database (NRD), an all-payor sample of discharges from approximately 60% of U.S. hospitalizations. Discharges between October 2015 and December 2018 were included. Maternity-associated hospitalizations, diagnosis of pyelonephritis, comorbid conditions, and incidence of severe maternal morbidity were identified using International Classification of Disease-10th Revision (ICD-10) diagnosis and procedure codes. Bivariate statistics, weighted to account for the complex survey methods in the NRD, were used to evaluate the association between antepartum, delivery, and postpartum hospital stays associated with pyelonephritis and maternal morbidity. Weighted regression models were used to evaluate the association between admission timing and maternal outcomes., Results: A total of 32,850 pyelonephritis admissions were identified, corresponding to a national estimate of 61,837 admissions. Of these, 1,465 (2.4%) were postpartum, 55,056 (89.0%) were antepartum, and 5,317 (8.6%) involved a delivery stay. Rates of severe maternal morbidity were higher in the postpartum group than the antepartum or delivery hospitalization groups (59.5 vs. 12.9 and 15.8%, respectively, p  < 0.001); when compared with antepartum hospitalizations, the adjusted relative risk for composite severe maternal morbidity for postpartum hospitalizations was 4.68 (95% confidence interval [CI]: 4.33, 5.05). Most of this difference was driven by rates of sepsis (53.2 vs. 11.0 vs. 10.9%)., Conclusion: Though relatively uncommon, postpartum hospitalizations for pyelonephritis are associated with higher rates of severe maternal morbidity, driven by differential rates of sepsis, than are antepartum or delivery-associated hospitalizations., Competing Interests: None declared., (Thieme. All rights reserved.)

The Delta pandemic wave saw increased maternal morbidity and mortality compared to prior viral strains. COVID-19 vaccination in pregnancy elicits detectable levels of neutralizing antibodies to SARS-CoV-2 wild type and SARS-CoV-2 Delta variants in both maternal and neonatal samples at delivery. Our results demonstrate the effectiveness of vaccination which confers an immunological response against newer, and potentially more dangerous, viral variants., (Copyright © 2023 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

Importance: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads., Methods: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators., Discussion: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero., Clinical Trials.gov Identifier: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Metz reports personal fees from Pfizer for her role as a medical consultant for a SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for RSV vaccination in pregnancy study, and grants from Gestvision for role as a site PI for a preeclampsia study outside the submitted work. Dr. Horwitz reported serving as a member of the National Academy of Medicine Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration. Dr. Costantine reported receiving grant support for work not related to this paper from Baxter International and Siemens Healthcare and personal consulting fees not related to this paper from Progenity and Siemens Healthcare. These disclosures do not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Metz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130-139/80-89 mm Hg and pregnancy outcomes., Methods: We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130-139/80-89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA)., Results: Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130-139/80-89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38-0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA., Conclusion: In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA., Clinical Trial Registration: ClinicalTrials.gov , NCT02299414., Competing Interests: Financial Disclosure Alan T.N. Tita reported money was paid to his institution by Pfizer for his efforts on this study. Torri D. Metz disclosed money was paid to her from UpToDate for two topics on trial of labor after cesarean, and money was paid to her institution from Gestvision as a site PI for a preeclampsia point-of-care test; her institution received money to conduct the study (ended August 2020). She has been a site PI for Pfizer on a phase III RSV vaccine trial, and her institution received money to conduct the study. She has also been a member of the Pfizer medical advisory board (1/15/21) and site PI for a COVID-19 vaccination trial in pregnancy. She has served on the SMFM Board of Directors. Lorraine Dugoff reports money was paid to her institution from Laboratory Holdings, Inc. and Natera, Inc. Brenna L. Hughes reports receiving payment from UpToDate. Mary E. Norton reports receiving payment from the American Board of Obstetrics and Gynecology and Luna Genetics. Daniel Skupski disclosed he is a consultant for Cooper Surgical, Inc, and has received payment from Organon. Namasivayam Ambalayanan reports receiving payment from Resbiotic/AlveolusBio and Shire/Oak Hill Bio. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Hepatitis C virus and intrahepatic cholestasis of pregnancy (ICP) are well-known independent risk factors for adverse outcomes in pregnancy. In addition, it is well-established that there is an association between Hepatitis C and ICP. This study's objective was to describe the impact of having both Hepatitis C and ICP on maternal and obstetric outcomes compared to patients having either Hepatitis C or ICP., Methods: We conducted a retrospective cohort study of the Nationwide Readmissions Database, an all-payor sample of discharges from approximately 60% of US hospitalizations. Deliveries at 24-42+ weeks between 10/2015 and 12/2020 were included. Diagnosis of Hepatitis C and ICP, and outcomes related to severe maternal morbidity were identified using International Classification of Disease-10 codes. Patients were categorized based on Hepatitis C and ICP status. Weighted logistic and negative binomial regression analyses were used to evaluate the association between Hepatitis C and ICP status and outcomes, adjusting for patient and hospital characteristics. The primary outcome was any severe maternal morbidity; secondary outcomes included acute respiratory distress syndrome, acute kidney injury, sepsis, gestational diabetes, cesarean delivery, preterm birth, and hospital length of stay. We modeled interaction terms between ICP and Hepatitis C to assess whether there was a greater or lesser effect from having both conditions on outcomes than we would expect from additive combination of the individual components (i.e., synergy or antagonism)., Results: A total of 10,040,850 deliveries between 24-42+ weeks were identified. Of these, 45,368 had Hepatitis C only; 84,582 had ICP only; and 1,967 had both Hepatitis C and ICP. Patients with both Hepatitis C and ICP had 1.5-fold higher odds of developing severe maternal morbidity compared to having neither. There was an also an increased odds of severe maternal morbidity in patients with both Hepatitis C and ICP compared to patients with only Hepatitis C or ICP. Having both was also associated with higher odds of preterm birth and length of stay compared to having only Hepatitis C, only ICP, or neither (preterm birth: aOR 5.09, 95% CI 4.87-5.33 vs. neither; length of stay: 46% mean increase, 95% CI 35-58% vs. neither). Associations were additive-no significant interactions between hepatitis C and cholestasis were found on rates of severe maternal morbidity, acute respiratory distress syndrome, acute kidney injury, sepsis, cesarean section, or preterm birth (all p>0.05), and was minimal for gestational diabetes and length of stay., Conclusion: Hepatitis C and ICP are independent, additive risk factors for adverse maternal and obstetric outcomes. Despite physiologic plausibility, no evidence of a synergistic effect of these two diagnoses on outcomes was noted. These data may be useful in counseling patients regarding their increased risk of adverse outcomes when ICP presents in association with Hepatitis C versus ICP alone., Competing Interests: The authors report no conflict of interest., (Copyright: © 2023 Goins et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Increased duration of breastfeeding improves maternal cardiovascular health and may be especially beneficial in high-risk populations, such as those with chronic hypertension. Others have shown that individuals with hypertension are less likely to breastfeed, and there has been limited research aimed at supporting breastfeeding goals in this population. The impact of perinatal blood pressure control on breastfeeding outcomes among people with chronic hypertension is unknown., Objective: This study aimed to evaluate whether breastfeeding initiation and short-term duration assessed at the postpartum clinic visit differed according to perinatal blood pressure treatment strategy (targeting blood pressure <140/90 mm Hg vs reserving antihypertensive treatment for blood pressure ≥160/105 mm Hg)., Study Design: We performed a secondary analysis of the Chronic Hypertension and Pregnancy trial. This was an open-label, multicenter, randomized trial where pregnant participants with mild chronic hypertension were randomized to receive antihypertensive medications with goal blood pressure <140/90 mm Hg (active treatment) or deferred treatment until blood pressure ≥160/105 mm Hg (control). The primary outcome was initiation and duration of breastfeeding, assessed at the postpartum clinic visit. We performed bivariate analyses and log-binomial and cumulative logit regression models, adjusting models for variables that were unbalanced in bivariate analyses. We performed additional analyses to explore the relationship between breastfeeding duration and blood pressure measurements at the postpartum visit., Results: Of the 2408 participants from the Chronic Hypertension and Pregnancy trial, 1444 (60%) attended the postpartum study visit and provided breastfeeding information. Participants in the active treatment group had different body mass index class distribution and earlier gestational age at enrollment, and (by design) were more often discharged on antihypertensives. Breastfeeding outcomes did not differ significantly by treatment group. In the active and control treatment groups, 563 (77.5%) and 561 (78.1%) initiated breastfeeding, and mean durations of breastfeeding were 6.5±2.3 and 6.3±2.1 weeks, respectively. The probability of ever breastfeeding (adjusted relative risk, 0.99; 95% confidence interval, 0.93-1.05), current breastfeeding at postpartum visit (adjusted relative risk, 1.01; 95% confidence interval, 0.94-1.10), and weeks of breastfeeding (adjusted odds ratio, 0.87; 95% confidence interval, 0.68-1.12) did not differ by treatment group. Increased duration (≥2 vs <2 weeks) of breastfeeding was associated with slightly lower blood pressure measurements at the postpartum visit, but these differences were not significant in adjusted models., Conclusion: In a secondary analysis of the cohort of Chronic Hypertension and Pregnancy trial participants who attended the postpartum study visit and provided breastfeeding information (60% of original trial participants), breastfeeding outcomes did not differ significantly by treatment group. This suggests that maintaining goal blood pressure <140/90 mm Hg throughout the perinatal period is associated with neither harm nor benefit for short-term breastfeeding goals. Further study is needed to understand long-term breastfeeding outcomes among individuals with chronic hypertension and how to support this population in achieving their breastfeeding goals., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To estimate the rate of perinatal transmission of hepatitis C virus (HCV) infection, to identify risk factors for perinatal transmission of HCV infection, and to determine the viremic threshold for perinatal transmission., Methods: This was a prospective, multicenter, observational study of pregnant individuals at less than 24 weeks of gestation screened for HCV infection from 2012 to 2018 in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Individuals found to be HCV antibody-positive were followed throughout pregnancy. Children were followed for evidence of perinatal transmission at 2-6 months (HCV RNA testing) and at 18-24 months (HCV RNA and antibody testing) of life. The primary outcome was perinatal transmission, defined as positive test results at either follow-up time point., Results: A total of 109,379 individuals were screened for HCV infection. Of the 1,224 participants who screened positive, 772 (63.1%) enrolled and 432 of those 772 (56.0%) had data available to assess primary outcome. The overall rate of perinatal transmission was 6.0% (26/432, 95% CI 4.0-8.7%). All children with HCV infection were born to individuals with demonstrable viremia. In viremic participants (n=314), the perinatal transmission rate was 8.0% (95% CI 5.2-11.5%). Risk factors for perinatal transmission included HCV RNA greater than 106 international units/mL (adjusted odds ratio [aOR] 8.22, 95% CI 3.16-21.4) and vaginal bleeding reported at any time before delivery (aOR 3.26, 95% CI 1.32-8.03). A viremic threshold for perinatal transmission could not be established., Conclusion: Perinatal transmission of HCV infection was limited to viremic individuals. High viral loads and antepartum bleeding were associated with perinatal transmission., Competing Interests: Financial Disclosure Mona Prasad served on the medical advisory board for Gilead. Brenna Hughes disclosed receiving payment from UpToDate and the Johns Hopkins DSMB. Ana Puga disclosed that she is cochair of the Broward County Perinatal HIV Network (no compensation) and a full-time employee of ViiV Healthcare since 2018. Torri D. Metz disclosed receiving UpToDate royalties for two topics on trial of labor after cesarean. Her institution received payment from Gestvision for her being a site PI for a preeclampsia point-of-care test (institution received money to conduct study [ended August 2020]) and from Pfizer for being a site PI for a Phase III respiratory syncytial virus (RSV) vaccine trial (institution received money to conduct the study). She has been a member of the medical advisory board for Pfizer, a site PI for a COVID-19 vaccination trial, and has served on the Board of Directors for the Society for Maternal-Fetal Medicine. Geeta Swamy reports money was paid to her from GlaxoSmithKline, Pfizer, and WebMD/Medscape. Andrew Wiznia received payment for a consultancy with Janssen Pharmaceuticals, where he has been a chairperson of the Independent Data Safety Monitoring Board. He has also received payment from Merck for a consultancy and protocol development. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Cardiac disease is a leading cause of severe maternal morbidity (SMM). We sought to estimate the effects of race and rural-urban status on cardiac-specific severe maternal morbidity ("cardiac SMM") in North Carolina., Methods: This retrospective study used the 2019 North Carolina State Inpatient Database (SID). Diagnosis codes were used to identify births, comorbidities, modified World Health Organization (mWHO) cardiac category, and outcomes. Hospital-level data were obtained from publicly available sources and the SID datasets. The primary outcome was a composite of cardiac SMM., Results: Of 106,778 births, 369 had mWHO category I-II disease, and 366 had mWHO category II/III-IV disease. Individuals with cardiac disease had higher rates of cardiac SMM (10.4% versus 0.27% versus 0.13% for mWHO II/III-IV, mWHO I/II, and no disease, respectively). Among patients with mWHO II/III-IV disease, 60.0% of rural residents delivered at hospitals with advanced cardiac capabilities versus 80.8% of urban residents; there were no statistically significant differences in cardiac SMM rates (11.3% versus 10.1% for rural versus urban individuals, P = NS). In contrast, there were pronounced disparities in cardiac SMM among Black individuals compared with White individuals (0.28% versus 0.13%, P < .001), especially among individuals with mWHO II/III-IV disease (23.71% versus 5.41%, P < .001)., Limitations: Cardiac disease and outcomes were identified based on diagnosis and procedure codes. Identifying complications subsequent to the delivery hospitalization was not possible., Conclusions: In North Carolina, there is a pronounced racial disparity in cardiac SMM during delivery hospitalizations, which is driven by patients with mWHO II/III-IV disease., Competing Interests: Acknowledgments: Financial support. Dr. Federspiel is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002553. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Meng is supported by a Mentored Research Training Grant from the Foundation for Anesthesia Education and Research. The North Carolina State Inpatient Database is a product of the Healthcare Cost and Utilization Project of the United States Agency for Healthcare Research and Quality, in concert with the North Carolina Department of Health and Human Services. This project was supported by the National Center for Advancing Translational Sciences through Grant Award TL1TR002555. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This paper was presented in preliminary form at the 2022 NC Obstetrical and Gynecological Society Meeting (April 8-10, 2022; Kiawah Island, South Carolina)., (Copyright ©2023 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.)

Importance: Multiple postpartum scenarios require uterine exploration or instrumentation. These may introduce bacteria into the uterus, increasing the risk of endometritis. Data on the use of antibiotics in these scenarios is limited, resulting in few guidelines and divergent care., Objective: To describe postpartum scenarios requiring uterine exploration and/or instrumentation, review data on antibiotic prophylaxis, and delineate antibiotic recommendations for each scenario., Evidence Acquisition: Original articles were obtained from literature search in PubMed, MEDLINE, and OVID; pertinent articles were reviewed., Results: These recommendations are based on published evidence and professional society guidelines. Antibiotic prophylaxis following manual placenta removal should include 1-time combination of ampicillin 2 g intravenously (IV) or cefazolin 1 g IV, plus metronidazole 500 mg IV. Antibiotic prophylaxis before postpartum dilation and curettage, manual vacuum aspiration, and intrauterine balloon tamponade should include 1-time combination of ampicillin 2 g IV plus metronidazole 500 mg IV. If the patient in any of the above scenarios has received group B Streptococcus prophylaxis, then only metronidazole is recommended. Further randomized clinical trials are needed to optimize these regimens., Conclusions: Uterine exploration or instrumentation increases the risk of postpartum endometritis and requires antibiotic prophylaxis. For manual placenta removal, we recommend 1-time combination of ampicillin 2 g IV or cefazolin 1 g IV, plus metronidazole 500 mg IV. For dilation and curettage, manual vacuum aspiration, and intrauterine balloon tamponade, we recommend 1-time combination of ampicillin 2 g IV plus metronidazole 500 mg IV. For patients who already received antibiotic prophylaxis for group B Streptococcus , we recommend 1-time dose of metronidazole 500 mg IV., Relevance: Providers can utilize our guidelines to prevent postpartum endometritis in these scenarios requiring postpartum uterine exploration and/or instrumentation.

Importance: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis., Methods: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms., Discussion: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options., Registration: NCT05172024., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Helen Chu reported consulting for Merck, GSK, Pfizer, Ellume, Janssen, Vindico CME, and the Bill and Melinda Gates Foundation, and receiving research support from Gates Ventures, Ellume, and Sanofi Pasteur. She also serves as a co-investigator on studies funded by Pfizer, Novavax, and GSK. Maged Costantine reported receiving grant support for work not related to RECOVER work/publications from Baxter International and Siemens Healthcare and personal consulting fees not related to this paper from Progenity, Quidel Ortho, and Siemens Healthcare. Kristine Erlandson reported research funding from Gilead Sciences and consulting payments from Gilead Sciences, Merck, and ViiV Pharmaceuticals, all paid to the University of Colorado. Emily Gallagher reported consulting for Novartis, Flare Therapeutics and Seagen. Edward Gardner reported research support (clinical trials) from Gilead Sciences, ViiV Healthcare, and Cepheid. Jason Goldman reported research support from Gilead, Eli Lilly and Regeneron; grants from Gilead, Merck (BARDA); personal fees for consulting from Gilead, Eli Lilly; and non-financial support from Adaptive Biotechnologies and Labcorp/Monogram Biosciences outside the submitted work. Timothy Heinrich reported grant support from Merck Inc. and consulting fees from Roche. Rachel Hess reported serving as Data Safety Monitoring Board member for Astellas Pharmaceuticals unrelated to the current work. Leora Horwitz reported being a member of the National Academy of Medicine Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration. Priscilla Hsue reported receiving honoraria from Gilead and Merck unrelated to study topic, receiving study drug from Regeneron unrelated to study topic, and receiving a research grant from Novartis. Judith James reported OMRF has licensed her IP to Progentec Biosciences, has received grant support from Progentec Biosciences, and serves on Advisory Committees to Glaxo Smith Klein, Merck and Novartis. Arthur Kim reports providing educational materials to Clinical Care Options and UpToDate and serving on a Data Safety Monitoring board for Kintor Pharmaceuticals, Ltd. Bruce Levy reported serving as a consultant for AstraZeneca, Entrinsic Biosciences, Gossamer Bio and Nocion Therapeutics and receiving research support from Amgen, Genentech, GlaxoSmithKline, Pieris Pharmaceuticals, SRA and Sanofi unrelated to the current work. Vincent Marconi reported receiving grants from NIH during the conduct of the study and grants from NIH, Veteran Affairs, and Centers for Disease Control and Prevention; grants, personal fees, nonfinancial support, and other from Lilly and Gilead; grants and personal fees from ViiV; and nonfinancial support from Bayer outside the submitted work. Grace McComsey reported serving as consultant for Merck, Gilead, ViiV, Janssen and have received research support from Pfizer, Vanda, Genentech, Roche, Redhill and Cognivue. Torri Metz reported being a site PI and a participant in the medical advisory board for the planning of a Pfizer clinical trial of SARS-CoV-2 vaccination in pregnancy. She also reported being a site PI for a Pfizer study evaluating the pharmacokinetics of Paxlovid in pregnant people with COVID-19. Janet Mullington reported support for investigator-initiated research by "Open Medicine Foundation and the Patient-Led Research Collaborative" Princess Ogbogu reported research support from Astrazeneca, GSK, Blueprint medical; advisory board for Astrazeneca, GSK, Sanofi, Kalvista; and consulting for Astrazeneca, GSK Sairam Parthasarathy reported research funding to Institution from Sergey Brin foundation of COVID and Long-COVID research. Michael Peluso reported consulting fees from Gilead Sciences and AstraZeneca, and service on data safety monitoring board for American Gene Technologies. Sean Quigley reported service on speaker Board for Servier, Alnylam, Agios; service on advisory board for Recordati, Alexion. Franz Rischard reported research support from NIH/NHLBI, United Therapeutics, Acceleron/Merck, Janssen, Insmed, Aerovate, and Bayer; and consulting/advisory compensation from Acceleron and Bayer. Nadine Rouphael reported being a consultant for ICON and EMMES as a safety consultant for clinical trials; service on the advisory boards for Moderna; funds to institution from Sanofi, Lilly, Merck, Quidel and Pfizer. PJ Utz reported stock ownership of Gilead and PI of biomarker studies for Pfizer STOP-PASC paxlovid trial Juan Wisnivesky received receiving consulting honorarium from Sanofi, Banook, Prospero, PPD and Atea and research grants from Sanofi, Regeneron, Axella, and Arnold Consultants., (Copyright: © 2023 Horwitz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Importance: SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals., Objective: To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections., Design, Setting, and Participants: Prospective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, and Puerto Rico. Participants who were enrolled in the RECOVER adult cohort before April 10, 2023, completed a symptom survey 6 months or more after acute symptom onset or test date. Selection included population-based, volunteer, and convenience sampling., Exposure: SARS-CoV-2 infection., Main Outcomes and Measures: PASC and 44 participant-reported symptoms (with severity thresholds)., Results: A total of 9764 participants (89% SARS-CoV-2 infected; 71% female; 16% Hispanic/Latino; 15% non-Hispanic Black; median age, 47 years [IQR, 35-60]) met selection criteria. Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months., Conclusions and Relevance: A definition of PASC was developed based on symptoms in a prospective cohort study. As a first step to providing a framework for other investigations, iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.

Objective: To evaluate whether preterm birth rates changed in relation to the onset of the coronavirus disease 2019 (COVID-19) pandemic and whether any change depended on socioeconomic status., Methods: This is an observational cohort study of pregnant individuals with a singleton gestation who delivered in the years 2019 and 2020 at 1 of 16 U.S. hospitals of the Maternal-Fetal Medicine Units Network. The frequency of preterm birth for those who delivered before the onset of the COVID-19 pandemic (ie, in 2019) was compared with that of those who delivered after its onset (ie, in 2020). Interaction analyses were performed for people of different individual- and community-level socioeconomic characteristics (ie, race and ethnicity, insurance status, Social Vulnerability Index (SVI) of a person's residence)., Results: During 2019 and 2020, 18,526 individuals met inclusion criteria. The chance of preterm birth before the COVID-19 pandemic was similar to that after the onset of the pandemic (11.7% vs 12.5%, adjusted relative risk 0.94, 95% CI 0.86-1.03). In interaction analyses, race and ethnicity, insurance status, and the SVI did not modify the association between the epoch and the chance of preterm birth before 37 weeks of gestation (all interaction P >.05)., Conclusion: There was no statistically significant difference in preterm birth rates in relation to the COVID-19 pandemic onset. This lack of association was largely independent of socioeconomic indicators such as race and ethnicity, insurance status, or SVI of the residential community in which an individual lived., Competing Interests: Financial Disclosure: Torri D. Metz disclosed receiving payment from UpToDate (royalties for two topics on trial of labor after cesarean). Money was paid to her institution from Gestvision (site PI for preeclampsia point-of-care test; institution received money to conduct study [ended August 2020])and Pfizer (site PI for Phase III respiratory syncytial virus [RSV] vaccine trial, institution received money to conduct study). She is a member of medical advisory board for Pfizer and site PI for a COVID-19 vaccination trial in pregnancy Society for Maternal-Fetal Medicine Board of Directors (unpaid). Brenna L. Hughes disclosed receiving payment from Merck, UpToDate, and Johns Hopkins. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Importance: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER- Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads., Methods: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators., Discussion: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero., Registration: NCT05172024.

Background: Data regarding the microbiome of the gestational membranes are emerging and conflicting. Shifts in the microbial communities in the setting of labor, rupture of membranes, and intraamniotic infection are yet to be understood., Objective: This study aimed to characterize the microbiome of the gestational membranes of women in labor or with ruptured membranes, including those with and without intraamniotic infection., Study Design: Women with a singleton pregnancy at ≥28 weeks' gestation undergoing unscheduled cesarean delivery in the setting of labor or rupture of membranes were included. Demographic and clinical variables were collected. We defined suspected intraamniotic infection by standard clinical criteria; placentae and gestational membranes were also reviewed for histologic evidence of infection. Sterile swabs were collected from membranes at the time of delivery. Bacteria were cultured from the swabs, and the isolates were sequenced. DNA extraction and 16S sequencing of the swabs were also performed. Bacterial taxonomy was assigned to each sequence. Alpha diversity indices and beta-diversity metrics were calculated to test for differences in microbial community diversity and composition between uninfected and infected groups. Differential abundance of bacteria between infected and uninfected groups was tested at the class, family, and genus level., Results: Samples were collected from 34 participants. Clinical intraamniotic infection was diagnosed in 38% of participants, although 50% of placentae and membranes demonstrated histologic signs of infection. Of all samples, 68% grew bacteria on culture; this included 62% of the uninfected samples and 77% of the infected samples (P=.83). Multiple measures of alpha diversity were not significantly different between uninfected and infected groups. Similarly, analysis of beta diversity revealed that the microbial community was not significantly different between the uninfected and infected group. Several bacteria traditionally characterized as pathogenic, including Actinomyces and Streptococcus agalactiae, were identified in both infected and uninfected samples., Conclusion: The pathogenesis and clinical implications of intraamniotic infection remain poorly understood. Diverse bacteria are present in both infected and uninfected gestational membranes. A unique microbiologic signature may exist among the gestational membranes following labor or rupture of membranes, and further characterization of the pathogens specifically implicated in intraamniotic infection may allow for targeted therapy., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: 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., Objective: This study aimed to evaluate whether the risk of SARS-CoV-2 infection during pregnancy persists after an acute maternal illness., Study Design: 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 at <20 weeks of gestation in both groups were excluded. The study outcomes included fetal or neonatal death, preterm birth at <37 weeks of gestation and <34 weeks of gestation, hypertensive disorders of pregnancy (HDP), any major congenital malformation, and size for gestational age of <5th or <10th percentiles at birth based on published standards. HDP that were collected included HDP and preeclampsia with severe features, both overall and with delivery at <37 weeks of gestation., Results: 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 at <37 weeks of gestation (19.6% vs 13.8%; adjusted relative risk, 1.29; 95% confidence interval, 1.02-1.63), and HDP with delivery at <37 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 at <34 weeks of gestation, any major congenital malformation, and size for gestational age of <5th or <10th percentiles. In addition, there was no significant difference in the rate of gestational hypertension overall or preeclampsia with severe features., Conclusion: There was a modest increase in the risk of adverse pregnancy outcomes after SARS-CoV-2 infection., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Unacceptably high rates of severe maternal morbidity and mortality in the United States and stark racial disparities in outcomes are generating efforts to improve both research capacity and quality improvement in obstetrical care. Comprehensive, high-quality datasets on which to build these efforts are crucial to the success of obstetrical quality improvement efforts. However, existing data sources in obstetrics have notable limitations. Other medical and surgical specialties have addressed similar challenges through the creation of national registries, and we argue that obstetrics must take the same approach to improve outcomes. In this article, we summarized the current availability and limitations of large-scale data in obstetrics research and compared the data with registries developed in other specialties. Moreover, we have outlined the guiding principles for the development of a national obstetrics registry and have proposed future directions., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To evaluate whether delivering during the early the coronavirus disease 2019 (COVID-19) pandemic was associated with increased risk of maternal death or serious morbidity from common obstetric complications compared with a historical control period., Methods: This was a multicenter retrospective cohort study with manual medical-record abstraction performed by centrally trained and certified research personnel at 17 U.S. hospitals. Individuals who gave birth on randomly selected dates in 2019 (before the pandemic) and 2020 (during the pandemic) were compared. Hospital, health care system, and community risk-mitigation strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in response to the early COVID-19 pandemic are described. The primary outcome was a composite of maternal death or serious morbidity from common obstetric complications, including hypertensive disorders of pregnancy (eclampsia, end organ dysfunction, or need for acute antihypertensive therapy), postpartum hemorrhage (operative intervention or receipt of 4 or more units blood products), and infections other than SARS-CoV-2 (sepsis, pelvic abscess, prolonged intravenous antibiotics, bacteremia, deep surgical site infection). The major secondary outcome was cesarean birth., Results: Overall, 12,133 patients giving birth during and 9,709 before the pandemic were included. Hospital, health care system, and community SARS-CoV-2 mitigation strategies were employed at all sites for a portion of 2020, with a peak in modifications from March to June 2020. Of patients delivering during the pandemic, 3% had a positive SARS-CoV-2 test result during pregnancy through 42 days postpartum. Giving birth during the pandemic was not associated with a change in the frequency of the primary composite outcome (9.3% vs 8.9%, adjusted relative risk [aRR] 1.02, 95% CI 0.93-1.11) or cesarean birth (32.4% vs 31.3%, aRR 1.02, 95% CI 0.97-1.07). No maternal deaths were observed., Conclusion: Despite substantial hospital, health care, and community modifications, giving birth during the early COVID-19 pandemic was not associated with higher rates of serious maternal morbidity from common obstetric complications., Clinical Trial Registration: ClinicalTrials.gov, NCT04519502., Competing Interests: Financial Disclosure Torri D. Metz reports personal fees from Pfizer for her role as a medical consultant for a SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for SARS-CoV-2 vaccination in pregnancy study, grants from Pfizer for role as a site PI for RSV vaccination in pregnancy study, and grants from Gestvision for role as a site PI for a preeclampsia study outside the submitted work. Brenna L. Hughes reports personal fees from Merck for her role on a Medical Advisory Board outside of the submitted work. Tracy A. Manuck reports money was paid to her institution from the NIH (NICHD and NIEHS) and the State of North Carolina (PFAST Network Grant). She also received Cefalo Bowes grant funding (local UNC obgyn grant funding) where she was a mentor to fellow physicians. Hyagriv N. Simhan reports that he is an LLC Co-founder of Naima Health and personal fees from UpToDate outside of the submitted work. Cynthia Gyamfi-Bannerman reports receiving payment from Medela and Hologic. Alan T.N. Tita reports grants from CDC and from Pfizer for a COVID-19 in pregnancy trial outside of the submitted work. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Financial Disclosure Stephanie Ros has been an UpToDate author on Zika virus in pregnancy. Tani Malhotra currently serves on the Board of Directors of the Accreditation Council for Graduate Medical Education (ACGME). They do not represent the Board and this article is not a reflection of the ACGME BOD. Brenna Hughes disclosed receiving payment from UpToDate and Merck. She received grants from NIH unrelated to this study paid to Duke. The other authors did not report any potential conflicts of interest.

This study sought to assess the impact of COVID-19 on placental vasculature in the context of maternal symptomatology - comparing asymptomatic to symptomatic pregnant patients - and disease severity - comparing pregnant patients with mild, moderate, severe, and critical COVID-19 infection. PCR-confirmed COVID-19 positive pregnant patients in a single health system who delivered between 3/2020-5/2021 included. All patients had positive COVID test and delivered during the study period. Primary outcome was incidence of any vascular malperfusion on placental pathology. Secondary outcomes were FVM and MVM on placental pathology. Placental pathology compared between symptomatic (sCOVID) and asymptomatic (aCOVID) patients. Secondary analysis of symptomatic patients, comparing placental pathology between mild disease(mCOVID) and worse disease(moderate, severe, or critical-defined by 2020 NIH guidelines) (dCOVID), also performed. Of 112 patients, 53 (47%) had symptoms. Twenty-seven (24.1%) patients had evidence of vascular malperfusion; 26 (23.2%) had MVM. When comparing aCOVID and sCOVID patients, no difference in rate of vascular malperfusion identified, nor any differences in rates of FVM or MVM. Among sCOVID patients ( n  = 53), 39 (74%) had mCOVID and 14 (26%) had dCOVID (moderate n  = 4, severe n  = 9, critical n  = 1). Patients with dCOVID had earlier median delivery GA (37.4wks vs 39.2wks, p  = .03). No difference in latency from diagnosis to delivery seen between mCOVID and dCOVID groups (4.4 vs 3.0wks, p  = .96). Twelve (30.8%) patients had vascular malperfusion on pathology, all had mCOVID ( p  = .02). Eleven (28.2%) mCOVID patients had MVM; no dCOVID patients had evidence of vascular malperfusion ( p  = .03). No difference in FVM was found between cohorts. Symptomatic COVID-19 infection did not impact placental vasculature differently than asymptomatic infection, even when stratifying by trimester of infection. Among pregnant patients with symptomatic COVID-19, mild disease was associated with placental vascular changes on the maternal side while severe disease was not. Further studies are needed to understand the implications of these findings.

Objective: To assess the implementation of an antihypertensive pathway order set to improve treatment of severe hypertension in pregnancy and the postpartum period in the inpatient setting., Study Design: A multi-disciplinary task force created a hypertensive pathway order set and provided staff training. The order set allowed providers to initiate a treatment algorithm, which then gave nurses guidelines to recheck blood pressures and progressively increase short-acting antihypertensive dosage if needed. Pregnant and postpartum patients documented to have ≥2 consecutive severe range blood pressures in the year prior (2017) and the year after (2019) implementation of the pathway were included. Primary outcomes included whether any antihypertensive was given, whether it was given for all instances of severe hypertension, and time to antihypertensive administration., Results: A total of 566 patients with severe hypertension were included-304 in the pre-implementation year and 262 in the post-implementation year. Significantly more patients received an antihypertensive at least once (67 % versus 80 %, p < 0.01) and for all instances of severe hypertension (29 % versus 47 %, p < 0.01) in the post-intervention cohort. There was a significant improvement in time to antihypertensive administration (24 versus 10 min, p < 0.01)., Conclusion: This study evaluates the efficacy of an antihypertensive intervention in the Southeast United States, which is particularly significant given the region's higher rates of hypertension and hypertension-related mortality. This study provides confirmatory evidence that implementation of a standardized order set along with measuring compliance and staff education is associated with improved treatment rates and time to treatment administration., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.)

Background: The purpose of this study was to estimate prevalence of asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among patients admitted to obstetric inpatient units throughout the United States as detected by universal screening. We sought to describe the relationship between obstetric inpatient asymptomatic infection rates and publicly available surrounding community infection rates., Methods: A cross-sectional study in which medical centers reported rates of positive SARS-CoV-2 testing in asymptomatic pregnant and immediate postpartum patients over a 1-3-month time span in 2020. Publicly reported SARS-CoV-2 case rates from the relevant county and state for each center were collected from the COVID Act Now dashboard and the COVID Tracking Project for correlation analysis., Results: Data were collected from 9 health centers, encompassing 18 hospitals. Participating health centers were located in Alabama, California, Illinois, Louisiana, New Jersey, North Carolina, Pennsylvania, Rhode Island, Utah, and Washington State. Each hospital had an active policy for universal SARS-CoV-2 testing on obstetric inpatient units. A total of 10 147 SARS-CoV-2 tests were administered, of which 124 were positive (1.2%). Positivity rates varied by site, ranging from 0-3.2%. While SARS-CoV-2 infection rates were lower in asymptomatic obstetric inpatient groups than the surrounding communities, there was a positive correlation between positivity rates in obstetric inpatient units and their surrounding county (P=.003, r=.782) and state (P=.007, r=.708)., Conclusions: Given the correlation between community and obstetric inpatient rates, the necessity of SARS-CoV-2-related healthcare resource utilization in obstetric inpatient units may be best informed by surrounding community infection rates., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth., Methods: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth., Results: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99)., Conclusions: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.)., (Copyright © 2022 Massachusetts Medical Society.)

Background: Both neighborhood disadvantage and close contact with children have been associated with seroprevalence of cytomegalovirus in pregnancy. However, it is unknown which individual factors influence whether seropositive women are likely to have ongoing viral shedding., Objective: This study aimed to define the frequency of and risk factors for ongoing maternal cytomegalovirus shedding across gestation among seropositive pregnant women., Study Design: This was a prospective cohort study of women who were cytomegalovirus seropositive at a single tertiary care hospital between September 1, 2018, and September 1, 2020. The participants were eligible if positive for cytomegalovirus immunoglobulin G during the first trimester of pregnancy. Urine samples were planned to be collected from each trimester. DNA was isolated in urine samples to detect and quantitate cytomegalovirus immediate-early 1 gene. Participants were classified as "ever shedder" if cytomegalovirus was detected in any urine sample and "never shedder" if cytomegalovirus was never detected. Patient demographics and characteristics were compared between groups. Stochastic search variable selection (with a posterior probability of inclusion of >0.5) was used to identify predictors of cytomegalovirus shedding at any time point. Forward selection modeling was used as a sensitivity check for independent risks., Results: A total of 240 participants who were cytomegalovirus immunoglobulin G seropositive were enrolled, with 567 urine samples analyzed across gestation. Fifty-eight participants (24.2%) were "never shedders", and 182 participants (75.8%) were "ever shedders." The characteristics and demographics were similar between cohorts. With stochastic search variable selection, nulliparity was the only variable selected (odds ratio, 1.82; 95% credible interval, 1.00-4.09; Bayes factor, 2.22). Furthermore, nulliparity was selected with standard logistic regression, with an odds ratio and 95% confidence interval of 1.89 (1.00-3.58). Sociodemographic characteristics, such as age, race, education level, occupation, children at home, children in daycare, housing type, insurance type, income, and concurrent infections, were not associated with shedding. The only positive neonatal sample (0.42%) was detected from a participant who had cytomegalovirus detected in all 3 time points., Conclusion: Approximately 75% of women who were positive for cytomegalovirus immunoglobulin G shed virus at some point during gestation. Nulliparity was the only variable selected that was associated with shedding., (Copyright © 2022 Elsevier Inc. All rights reserved.)