Risk of Postpartum Hemorrhage in Hypertensive Disorders of Pregnancy: Stratified by Severity.

OBJECTIVE: We aimed to determine the composite maternal hemorrhagic outcome (CMHO) among individuals with and without hypertensive disorders of pregnancy (HDP), stratified by disease severity. Additionally, we investigated the composite neonatal adverse outcome (CNAO) among individuals with HDP who had postpartum hemorrhage (PPH) versus did not have PPH. STUDY DESIGN: Our retrospective cohort study included all singletons who delivered at a Level IV center over two consecutive years. The primary outcome was the rate of CMHO, defined as blood loss ≥1,000 mL, use of uterotonics, mechanical tamponade, surgical techniques for atony, transfusion, venous thromboembolism, intensive care unit admission, hysterectomy, or maternal death. A subgroup analysis was performed to investigate the primary outcome stratified by (1) chronic hypertension, (2) gestational hypertension and preeclampsia without severe features, and (3) preeclampsia with severe features. A multivariable regression analysis was performed to investigate the association of HDP with and without PPH on a CNAO which included APGAR <7 at 5 minutes, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, seizures, neonatal sepsis, meconium aspiration syndrome, ventilation >6 hours, hypoxic-ischemic encephalopathy, or neonatal death. RESULTS: Of 8,357 singletons, 2,827 (34%) had HDP. Preterm delivery <37 weeks, induction of labor, prolonged oxytocin use, and magnesium sulfate usage were more common in those with versus without HDP (p < 0.001). CMHO was higher among individuals with HDP than those without HDP (26 vs. 19%; adjusted relative risk [aRR] 1.11, 95% CI 1.01-1.22). In the subgroup analysis, only individuals with preeclampsia with severe features were associated with higher CMHO (n = 802; aRR 1.52, 95% CI 1.32-1.75). There was a higher likelihood of CNAO in individuals with both HDP and PPH compared to those with HDP without PPH (aRR 1.49, 95% CI 1.06-2.09). CONCLUSION: CMHO was higher among those with HDP. After stratification, only those with preeclampsia with severe features had an increased risk of CMHO. Among individuals with HDP, those who also had a PPH had worse neonatal outcomes than those without hemorrhage. KEY POINTS: · Individuals with HDP had an 11% higher likelihood of CMHO.. · After stratification, increased CMHO was limited to those with preeclampsia with severe features.. · There was a higher likelihood of CNAO in those with both HDP and PPH compared to HDP without PPH..

Implementing a Bundle for Evidence-based Cesarean Delivery May Not Be As Beneficial as Expected: A Multi-center, Pre- and Post- Study.

BACKGROUND: Standardization of procedures improves outcomes. Though systematic reviews have summarized the evidence-based steps (EBS) of cesarean delivery (CD), their bundled implementation has not been investigated. OBJECTIVE: In this pre- and post-implementation trial, we sought to ascertain if bundled EBS of CD, compared to surgeon's preference, improves outcomes. STUDY DESIGN: A StaRI (Standards for Reporting Implementation Studies) compliant, multi-center pre- and post-implementation trial at 4 teaching hospitals was conducted. The pre-implementation period consisted of CD done based on the physicians' preferences for 3 months; educational intervention (e.g., didactics, badge cards, posters, video) occurred at the 4th month. CDs in post-implementation period employed the bundled EBS. A pre-planned 10% randomized audit of both groups assessed adherence and uptake of EBS. The primary outcome was a composite maternal morbidity (CMM), which included estimated blood loss > 1,000 mL, blood transfusion, endometritis, post-partum fever, wound complications, sepsis, thrombosis, ICU admission, hysterectomy, or death. The secondary outcome was a composite neonatal morbidity (CNM) and some of its components were 5-min Apgar score < 7, positive pressure oxygen use, hypoglycemia, or sepsis. A priori Bayesian sample size calculation indicated 700 CD in each group was needed to demonstrate 20% relative reduction (from 15% to 12%) of CMM with 75% certainty. Bayesian logistic regression with neutral priors was used to calculate likelihood of net-improvement in adjusted relative risk (aRR) with 95% credible intervals (CrI). RESULTS: A total of 1,425 consecutive CD (721 in pre- and 704 in post-implementation group) were examined. Audited data indicated that the baseline EBS utilization rate during the pre-implementation period was 79%; after the implementation bundled EBS of CD the audited adherence was 89%-an uptake of 10.0% of the EBS. In four aspects, the maternal characteristics differed significantly in the pre- and post-implementation periods: race/ethnicity, hypertensive disorder, and the relative contribution of the 4 centers to the cohorts and the gestational age at delivery, but the indications for CD and whether its duration was < versus > 60 min did not. The rates of CMM in the pre- and post-implementation groups were 26% and 22%, respectively (aRR, 0.88; 95% CrI, 0.73-1.04), with a 94 % Bayesian probability of a reduction in CMM. The CNM occurred in 37% of the pre- and in 41% of the post-implementation group (aRR, 1.12; 95% CrI 0.98-1.39), with a 95% Bayesian probability of worsening in CNM. When CMM were segregated by preterm (<37 wks) and term (> 37 weeks) CD, the improvement in maternal outcomes persisted; when CNM were segregated by gestational age subgroupsthe potential for worsening neonatal outcomes persisted as well. CONCLUSIONS: Standardization of the evidence-based bundled steps of cesarean delivery resulted in a modest reduction of the composite maternal outcome; however, a paradoxical increase in neonatal composite morbidity was noted. Although individual evidence-based steps may be of value, while awaiting additional intervention trials a formal bundling of such steps is currently not recommended.

Postpartum pharmacologic thromboprophylaxis and complications in a US cohort.

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.

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

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.

Misoprostol with balloon vs oxytocin with balloon in high-risk pregnancy induction: a randomized controlled trial.

BACKGROUND: Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery. Limited data exist on the safest method of induction to use in this specific patient population. OBJECTIVE: This study aimed to compare the combination of oxytocin plus a Cook balloon vs misoprostol plus a Cook balloon for induction of labor in high-risk pregnancies. STUDY DESIGN: We conducted an open-label, randomized controlled trial at a single institution from July 2020 to May 2022. The study was approved by the institutional review board and registered with ClinicalTrials.gov (NCT04492072). Individuals with a high-risk pregnancy, at least ≥22 weeks' gestation, with a singleton in cephalic presentation, Bishop score ≤6, and intact membranes were offered enrollment. A high-risk pregnancy was defined as a pregnancy with any of the following complications: hypertensive disease of pregnancy, fetal growth restriction, oligohydramnios, suspected placental abruption requiring delivery, uncontrolled pregestational diabetes, or abnormal biophysical profile or nonstress test requiring delivery. The primary outcome was the rate of cesarean delivery. Secondary maternal outcomes included induction to delivery interval, number of vaginal deliveries within 24 hours, rates of uterine tachysystole, intraamniotic infection, operative vaginal delivery, and postpartum hemorrhage. Secondary fetal outcomes included fetal heart rate abnormalities, stillbirth, Apgar scores <7 at 5 minutes, admission to the neonatal intensive care unit, arterial umbilical blood pH <7.1, sepsis, and neonatal death. A subgroup analysis was planned for the primary outcome to assess the different indications for cesarean delivery. An intent-to-treat analysis was performed. RESULTS: During the 22 months of the trial, a total of 150 patients were randomized, and 73 (49%) of those were induced with oxytocin and a Cook balloon and 77 (51%) were induced with misoprostol and a Cook balloon. There was no significant difference in the overall rate of cesarean delivery between the study groups, (21.9% vs 31.1%; relative risk, 0.70; 95% confidence interval, 0.41-1.21), nor among those for which the cesarean delivery was performed for a specific indication. There were no differences in the secondary maternal and fetal or neonatal adverse outcomes. CONCLUSION: In high-risk pregnancies, the rate of cesarean delivery and adverse maternal and fetal outcomes were similar for induction of labor with oxytocin and a Cook balloon and for induction with misoprostol and a Cook balloon.

Association of adverse outcomes with three-tiered risk assessment tool for obstetrical hemorrhage.

BACKGROUND: Guidelines promote stratification for the risk for postpartum hemorrhage among parturients, although the evidence for the associated differential morbidity among the groups remains inconsistent among published reports. OBJECTIVE: Using the California Maternal Quality Care Collaborative schema modified by the American College of Obstetrics and Gynecology, we compared the composite maternal hemorrhagic outcome and the composite neonatal adverse outcome among singletons who were categorized after delivery by the researchers as low-, medium-, or high-risk for postpartum hemorrhage. We hypothesized that the composite outcomes would be significantly different among the individuals in the different 3-tiered categories. STUDY DESIGN: This was a retrospective cohort study of all singleton parturients with a gestational age of at least 14 weeks who delivered at a single site within 1 year. The composite maternal hemorrhagic outcome included any of the following: estimated blood loss ≥1000 mL, use of uterotonics (excluding prophylactic oxytocin) or Bakri balloon, surgical management of postpartum hemorrhage, blood transfusion, hysterectomy, thromboembolism, admission to the intensive care unit, or maternal death. The composite neonatal adverse outcome included Apgar score <7 at 5 minutes, birth injury, bronchopulmonary dysplasia, intraventricular hemorrhage, neonatal seizure, sepsis, ventilation > 6 hrs., brachial plexus palsy, hypoxic-ischemic encephalopathy, or neonatal death. Multivariable Poisson regression models with robust error variance were used to estimate the adjusted relative risks with 95% confidence intervals. RESULTS: Of the 4544 deliveries in the study period, 4404 (96.7%) met the inclusion criteria, and among them, 1745 (39.6%) were categorized as low, 1376 (31.2%) as medium, and 1283 (29.1%) as high risk. Overall, 941 (21.4%) participants experienced the composite maternal hemorrhagic outcome with 285 (16.4%) of those being in the low-risk group, 319 (23.2%) in the medium-risk group, and 337 (26.3%) in the high-risk group. Among all parturients, 95.7% in the low-, 89.4% in the medium-, and 85.3% in the high-risk group neither had an estimated blood loss or a quantified blood loss ≥1000 mL nor were transfused. After multivariable adjustment and when compared with the low-risk group, there was a significantly higher risk for the composite maternal hemorrhagic outcome in the medium-risk group (adjusted relative risk, 1.23; 95% confidence interval, 1.05-1.43) and in the high-risk group (adjusted relative risk, 1.51; 95% confidence interval, 1.31-1.75). Overall, 366 newborns (8.4%) developed the composite neonatal adverse outcome with 76 (4.2%) in of those being in the low-risk group, 153 (11.3%) in the medium-risk group, and 140 (11.1%) in the high-risk group. After multivariable adjustment and when compared with the low-risk group, there were no significant differences in the composite neonatal adverse outcome in the medium- (adjusted relative risk, 1.27; 95% confidence interval, 0.97-1.68) or the high-risk group (adjusted relative risk, 1.29; 95% confidence interval, 0.98-1.68). CONCLUSION: Although 8 of 10 parturients categorized as high risk neither had blood loss ≥1000 mL nor underwent transfusion, the risk stratification provides information regarding the composite maternal hemorrhagic outcome.

The Temporal Relationship Between the Coronavirus Disease 2019 (COVID-19) Pandemic and Preterm Birth.

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.

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

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.

Three-tiered fetal heart rate interpretation system and adverse neonatal and maternal outcomes: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to evaluate the rate of adverse neonatal or maternal outcomes in parturients with fetal heart rate tracings categorized as I, II or, III within the last 30 to 120 minutes of delivery. DATA SOURCES: The MEDLINE Ovid, Scopus, Embase, CINAHL, and Clinicaltrials.gov databases were searched electronically up to May 2022, using combinations of the relevant medical subject heading terms, keywords, and word variants that were considered suitable for the topic. STUDY ELIGIBILITY CRITERIA: Only observational studies of term infants reporting outcomes of interest with category I, II, or III fetal heart rate tracings were included. STUDY APPRAISAL AND SYNTHESIS METHODS: The coprimary outcome was the rate of either Apgar score <7 at 5 minutes or umbilical artery pH <7.00. Secondary outcomes were divided into neonatal and maternal adverse outcomes. Quality assessment of the included studies was performed using the Newcastle-Ottawa Scale. Random-effect meta-analyses of proportions were used to estimate the pooled rates of each categorical outcome in fetal heart rate tracing category I, II, and III patterns, and random-effect head-to-head meta-analyses were used to directly compare fetal heart rate tracings category I vs II and fetal heart rate tracing category II vs III, expressing the results as summary odds ratio or as mean differences with relative 95% confidence intervals. RESULTS: Of the 671 articles reviewed, 3 publications met the inclusion criteria. Among them were 47,648 singletons at ≥37 weeks' gestation. Fetal heart rate tracings in the last 30 to 120 minutes before delivery were characterized in the following manner: 27.0% of deliveries had category I tracings, 72.9% had category II tracings, and 0.1% had category III tracings. A single study, which was rated to be of poor quality, contributed 82.1% of the data and it did not provide any data for category III fetal heart rate tracings. When compared with category I fetal heart rate tracings (0.74%), the incidence of an Apgar score <7 at 5 minutes were significantly higher among deliveries with category II fetal heart rate tracings (1.51%) (odds ratio, 1.56; 95% confidence interval, 1.23-1.99) and among those with category III tracings (14.63%) (odds ratio, 14.46; 95% confidence interval, 2.77-75.39). When compared with category II tracings, category III tracings also had a significantly higher likelihood of a low Apgar score at 5 minutes (odds ratio, 14.46; 95% confidence interval, 2.77-75.39). The incidence of an umbilical artery pH <7.00 were similar among those with category I and those with category II tracings (0.08% vs 0.24%; odds ratio, 2.85; 95% confidence interval, 0.41-19.55). When compared with category I tracings, the incidence of an umbilical artery pH <7.00 was significantly more common among those with category III tracings (31.04%; odds ratio, 161.56; 95% confidence interval, 25.18-1036.42); likewise, when compared with those with category II tracings, those with category III tracings had a significantly higher likelihood of having an umbilical artery pH <7.00 (odds ratio, 42.29; 95% confidence interval, 14.29-125.10). Hypoxic-ischemic encephalopathy occurred with similar frequency among those with categories I and those with category II tracings (0 vs 0.81%; odds ratio, 5.86; 95% confidence interval, 0.75-45.89) but was significantly more common among those with category III tracings (0 vs 18.97%; odds ratio, 61.43; 95% confidence interval, 7.49-503.50). Cesarean delivery occurred with similar frequency among those with category I (13.41%) and those with category II tracings (11.92%) (odds ratio, 0.87; 95% confidence interval, 0.72-1.05) but was significantly more common among those with with category III tracings (14.28%) (odds ratio, 3.97; 95% confidence interval, 1.62-9.75). When compared with those with category II tracings, cesarean delivery was more common among those with category III tracings (odds ratio, 4.55; 95% confidence interval, 1.88-11.01). CONCLUSION: Although the incidence of an Apgar score <7 at 5 minutes and umbilical artery pH <7.00 increased significantly with increasing fetal heart rate tracing category, about 98% of newborns with category II tracings do not have these adverse outcomes. The 3-tiered fetal heart rate tracing interpretation system provides an approximate but imprecise measurement of neonatal prognosis.

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

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.

Racial and Ethnic Disparities among Pregnancies with Chronic Hypertension and Adverse Outcomes.

OBJECTIVE: We aimed to ascertain whether the risk of adverse pregnancy outcomes in the United States among individuals with chronic hypertension differed by maternal race and ethnicity and to assess the temporal trend. STUDY DESIGN: Population-based retrospective study using the U.S. Vital Statistics datasets evaluated pregnancies with chronic hypertension, singleton live births that delivered at 24 to 41 weeks. The coprimary outcomes were a composite maternal adverse outcome (preeclampsia, primary cesarean delivery, intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy) and a composite neonatal adverse outcome (preterm birth, small for gestational age, Apgar's score <5 at 5 minutes, assisted ventilation> 6 hours, seizure, or death). Multivariable Poisson regression models were used to estimate adjusted relative risks (aRRs) and 95% confidence intervals (CIs). RESULTS: Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased from 1.6 to 2.2%. After multivariable adjustment, an increased risk for the composite maternal adverse outcome was found in Black (aRR = 1.10, 95% CI = 1.09-1.11), Hispanic (aRR = 1.04, 95% CI = 1.02-1.05), and Asian/Pacific Islander (aRR = 1.07, 95% CI = 1.05-1.10), compared with White individuals. Compared with White individuals, the risk of the composite neonatal adverse outcome was higher in Black (aRR = 1.39, 95% CI = 1.37-1.41), Hispanic (aRR = 1.15, 95% CI = 1.13-1.16), Asian/Pacific Islander (aRR = 1.34, 95% CI = 1.31-1.37), and American Indian (aRR = 1.12, 95% CI = 1.07-1.17). The racial and ethnic disparity remained unchanged during the study period. CONCLUSION: We found a racial and ethnic disparity with maternal and neonatal adverse outcomes in pregnancies with chronic hypertension that remained unchanged throughout the study period. KEY POINTS: · Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased.. · Among people with chronic hypertension, there are racial and ethnic disparities in adverse outcomes.. · Black, Hispanic, and Asian/Pacific Islander have a higher risk of the adverse neonatal outcomes..

Association Between Giving Birth During the Early Coronavirus Disease 2019 (COVID-19) Pandemic and Serious Maternal Morbidity.

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.

Postpartum hemorrhage drills or simulations and adverse outcomes: a systematic review and Bayesian meta-analysis.

OBJECTIVE: To compare the rates of adverse outcomes with postpartum hemorrhage (PPH) before and after implementation of drills or simulation exercises. STUDY ELIGIBILITY CRITERIA: We included all English studies that reported on rates of PPH and associated complications during the pre- and post-implementation of interventional exercises. STUDY APPRASIAL AND SYNTHESIS METHODS: Two investigators independently reviewed the abstracts, and full articles for eligibility of all studies. Inconsistencies related to study evaluation or data extraction were resolved by a third author. The co-primary outcomes were the rate of PPH and of any transfusion; the secondary outcomes included admission to the intensive care unit (ICU), transfusion ≥ 4 units of packed red blood cells, hysterectomy, or maternal death. Study effects were combined by Bayesian meta-analysis and reported as risk ratios (RR) and 95% credible intervals (Cr). RESULTS: We reviewed 142 full length articles. Of these, 18 publications, with 355,060 deliveries-150,562 (42%) deliveries during the pre-intervention and 204,498 (57.6%) deliveries in the post-interventional period-were included in the meta-analysis. Using the Newcastle-Ottawa Scale, only three studies were considered good quality, and none of them were done in the US. The rate of PPH prior to intervention was 5.06% and 5.46% afterwards (RR 1.09, 95% CI 0.87-1.36; probability of reduction in the diagnosis being 21%). The likelihood of transfusion decreased from 1.68% in the pre-intervention to 1.27% in the post-intervention period (RR 0.80, 95% Cr 0.57-1.09). The overall probability of reduction in transfusion was 93%, albeit it varied among studies done in non-US countries (96%) versus in the US (23%). Transfusion of 4 units or more of blood occurred in 0.44% of deliveries before intervention and 0.37% afterwards (RR of 0.85, 95% CI 0.50-1.52), with the overall probability of reduction being 72% (76% probability of reduction in studies from non-US countries and 49% reduction with reports from the US). Surgical interventions to manage PPH, which was not reported in any US studies, occurred in 0.14% before intervention and 0.28% afterwards (RR 1.29; 95% CI 0.56-3.06; probability of reduction 27%). Admission to the ICU occurred in 0.10% before intervention and 0.08% subsequently (RR 0.92, 95% CI 0.58-1.43), with the overall probability of reduction being 65% (81% in studies from non-US countries and 27% from the study done in the US). Maternal death occurred in 0.17% in the pre-intervention period and 0.09% during the post-intervention (RR 0.62, 95% CI 0.33-1.05; probability of reduction 93% in studies from non-US countries and 82% in one study from the US). CONCLUSIONS: Interventions to reduce the sequelae of PPH are associated with decrease in adverse outcomes. The conclusion, however, ought not to be accepted reflexively for the US population. All of the studies on the topic done in the US are of poor quality and the associated probability of reduction in sequelae are consistently lower than those done in other countries. SYNOPSIS: Since the putative benefits of PPH drills or simulation exercises are based on poor quality pre- and post-intervention trials, policies recommending them ought to be revisited.

Racial and Ethnic Disparities in Primary Cesarean Birth and Adverse Outcomes Among Low-Risk Nulliparous People.

OBJECTIVE: To compare trend of primary cesarean delivery rate and composite neonatal and maternal adverse outcomes in low-risk pregnancies among racial and ethnic groups: non-Hispanic White, non-Hispanic Black, and Hispanic. METHODS: This population-based cohort study used U.S. vital statistics data (2015-2019) to evaluate low-risk, nulliparous patients with nonanomalous singletons who labored and delivered at 37-41 weeks of gestation. The primary outcome was the primary cesarean delivery rate. Secondary outcomes included composite neonatal adverse outcome (Apgar score less than 5 at 5 minutes, assisted ventilation for more than 6 hours, seizure, or death), and composite maternal adverse outcome (intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy), as well as infant death. Multivariable Poisson regression models were used to estimate adjusted relative risks (aRR) and 95% CIs. RESULTS: Among 4.3 million births, 60.6% identified as non-Hispanic White, 14.6% identified as non-Hispanic Black, and 24.8% identified as Hispanic. The rate of primary cesarean delivery was 18.5% (n=804,155). An increased risk for cesarean delivery was found in non-Hispanic Black (21.7%, aRR 1.24, 95% CI 1.23-1.25) and Hispanic (17.3%, aRR 1.09, 95% CI 1.09-1.10) individuals, compared with non-Hispanic White individuals (18.1%) after multivariable adjustment. There was an upward trend in the rate of primary cesarean delivery in all racial and ethnic groups ( P for linear trend<0.001 for all groups). However, the racial and ethnic disparity in the rate of primary cesarean delivery remained stable during the study period. The composite neonatal adverse outcome was lower in Hispanic individuals in all newborns (10.7 vs 8.3 per 1,000 live births, aRR 0.74, 95% CI 0.72-0.75), and in newborns delivered by primary cesarean delivery (18.5 vs 15.0 per 1,000 live births, aRR 0.73, 95% CI 0.70-0.76), compared with non-Hispanic White individuals. CONCLUSION: Using a nationally representative sample in the United States, we found racial and ethnic disparities in the primary cesarean delivery rate in low-risk nulliparous patients, which persisted throughout the study period.

Preterm cesarean delivery for nonreassuring fetal heart rate tracing: Risk factors and predictability of adverse outcomes.

OBJECTIVE: To compare adverse outcomes among preterm births that underwent cesarean delivery (CD) for non-reassuring fetal heart rate tracing (NRFHT) versus those that did not. STUDY DESIGN: Consortium on Safe Labor Database was utilized for this secondary analysis. Inclusion criteria were non-anomalous, singleton at 23.0 to 36.6 weeks who labored for at least 2 h. Composite adverse neonatal outcomes included any of the following intraventricular hemorrhage grade III or IV, seizures, mechanical ventilation, sepsis, necrotizing enterocolitis 2 or 3, or neonatal death. Composite adverse maternal outcomes included any of the following postpartum hemorrhage, endometritis, blood transfusion, chorioamnionitis, admission to intensive care unit, thromboembolism, or death. RESULTS: Of 228,438 births, 29,592 (13.0%) delivered preterm, and 16,679 (56.4%) labored for at least 2 hrs. CD for NR FHRT was done in 1,220 (7.3%). The rate of composite adverse neonatal outcome was different among those that had CD for NR FHRT (26.7%) versus those that did not (16.6%; aRR 1.59, 95% CI 1.43-1.76). Composite adverse maternal outcomes did not differ between the groups. The area under the curve for risk factors to identify composite adverse neonatal outcome was 0.81, and for composite adverse maternal outcomes, 0.64. CONCLUSIONS: Subsequent to CD for NR FHRT, composite adverse neonatal outcome is 59% higher among preterm births when compared to delivery with reassuring tracing; composite adverse maternal outcomes did not differ between the groups.

Maternal Education Level Among People with Diabetes and Associated Adverse Outcomes.

OBJECTIVE: The aim of the study is to determine the relation between education and adverse outcomes in individuals with pregestational or gestational diabetes. STUDY DESIGN: This population-based cohort study, using the U.S. vital statistics datasets, evaluated individuals with pregestational or gestational diabetes who delivered between 2016 and 2019. The primary outcome was composite neonatal adverse outcome including any of the following: large for gestational age (LGA), Apgar's score 6 hours, neonatal seizure, or neonatal death. The secondary outcome was composite maternal adverse outcomes including any of the following: admission to intensive care unit, transfusion, uterine rupture, or unplanned hysterectomy. Multivariable analysis was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CIs). RESULTS: Of 15,390,962 live births in the United States, 858,934 (5.6%) were eligible for this analysis. Compared with individuals with a college education and above, the risk of composite neonatal adverse outcome was higher in individuals with some college (aRR = 1.08, 95% CI = 1.07-1.09), high school (aRR = 1.06, 95% CI = 1.04-1.07), and less than high school (aRR = 1.05, 95% CI = 1.03-1.07) education. The components of composite neonatal adverse outcome that differed significantly between the groups were LGA, Apgar's score 6 hours. Infant death differed when stratified by education level. An increased risk of composite maternal adverse outcome was also found with a lower level of education. CONCLUSION: Among individuals with diabetes, lower education was associated with a modestly higher risk of adverse neonatal and maternal outcomes. KEY POINTS: · Education levels were associated with adverse outcomes among individuals with diabetes.. · Lower education is associated with multiple neonatal complications, including infant death.. · Individuals with varying levels of education are at higher risk for adverse maternal outcomes..

Diagnosis of fetal growth restriction in a cohort of small-for-gestational-age neonates at term: neonatal and maternal outcomes.

BACKGROUND: Small-for-gestational-age neonates (birthweight of <10th percentile for gestational age) are significantly more likely to have multiple adverse outcomes than appropriate-for-gestational-age neonates (birthweight of 10th-90th percentile). Most small-for-gestational-age neonates are undetected during pregnancy (ie, not diagnosed as fetal growth restriction), but the sequela of being undetected remains uncertain. OBJECTIVE: The primary objective of this study was to compare the composite neonatal adverse outcomes among singleton pregnancies that were at least 37 weeks and delivered small-for-gestational-age neonates, which were diagnosed as either fetal growth restriction during pregnancy (detected small for gestational age) or not (undetected small for gestational age). STUDY DESIGN: This was a secondary analysis of a retrospective cohort, the Consortium for Safe Labor. Singleton births at 37.0 to 41.6 weeks of gestation without congenital anomalies born small for gestational age were included in the analysis. The primary outcome was the rate of composite neonatal adverse outcome, defined as any of the following: Apgar score of <5 at 5 minutes, cardiopulmonary resuscitation at birth, respiratory distress syndrome, continuous positive airway pressure, mechanical ventilation, neonatal seizures, hypoxic-ischemic encephalopathy or diagnosis of asphyxia, intraventricular hemorrhage, necrotizing enterocolitis, neonatal sepsis, or fetal or neonatal death. The secondary outcome was the rate of composite maternal adverse outcome, which included any of the following: postpartum hemorrhage, peripartum infection, thromboembolism, hysterectomy, uterine rupture, eclampsia, intensive care unit admission, or maternal death. Small for gestational age with a prenatal diagnosis of fetal growth restriction (detected small for gestational age) was compared with small for gestational age without a prenatal diagnosis of fetal growth restriction (undetected small for gestational age). Multivariate logistic regression models were used to compare groups. A P value of <.05 was considered statistically significant. Gestational age-specific risks of composite neonatal adverse outcome and perinatal death were computed for each week of gestation among ongoing pregnancies. RESULTS: Of the 228,438 deliveries in the Consortium for Safe Labor, 18,607 (8.1%) met the inclusion criteria. Among these deliveries, 17,689 (95.0%) were undetected small for gestational age, and 918 (5.0%) were detected small for gestational age. The overall rate of composite neonatal adverse outcome was 3.0%. Moreover, the rate of composite neonatal adverse outcome was similar between undetected small for gestational age and detected small for gestational age (3.0% vs 3.9%, respectively; adjusted odds ratio, 1.33; 95% confidence interval, 0.88-2.00). Some components of the composite-respiratory distress syndrome, mechanical ventilation, and necrotizing enterocolitis-were significantly higher among undetected small for gestational age than among detected small for gestational age. The overall rate of composite maternal adverse outcome was 6.2%. The rate of composite maternal adverse outcome between undetected small for gestational age and detected small for gestational age (6.2% vs 5.1%, respectively; adjusted odds ratio, 0.84; 95% confidence interval, 0.60-1.18) was similar. In gestational age-specific comparisons of composite neonatal adverse outcome, no difference was found between the undetected small-for-gestational-age group and the detected small-for-gestational-age group except for in pregnancies >41 weeks. In pregnancies at 41.0 to 41.6 weeks, the rate of composite neonatal adverse outcome was significantly greater in detected small for gestational age than in undetected small for gestational age (10.0% vs 2.5%, respectively; P=.035). CONCLUSION: Antenatal detection of small for gestational age was not associated with improved composite neonatal adverse outcomes, although some components of morbidity improved with detection. Maternal outcomes did not differ between detected small for gestational age and undetected small for gestational age.