BACKGROUND:Individuals diagnosed with depression during pregnancy are more likely to develop cardiovascular disease (CVD) later in life. However, it remains unclear whether subclinical depressive symptoms or symptom trajectories across time are associated with indicators of cardiovascular health (CVH). Therefore, the present study evaluated the relationship between longitudinal depressive symptom trajectories beginning in pregnancy and future CVH. METHODS:This secondary analysis of the multisite prospective nuMoM2b-Heart Health Study and included participants with complete longitudinal data from early pregnancy to 2-7 years post-delivery. Participants self-reported depressive symptoms using the Edinburgh Postnatal Depression Scale (EPDS) at 6-13 weeks gestation (early pregnancy), 22-29 weeks gestation (mid- to late-pregnancy), and 2-7 years post-delivery. Latent class mixture modeling was conducted to identify longitudinal patterns of depressive symptoms across early pregnancy, mid-late pregnancy, and extended postpartum follow-up. Structural equation modeling was used to test whether EPDS trajectories were associated with latent CVH, adjusted for length of follow-up interval, pre-pregnancy BMI, gravidity, adverse pregnancy outcomes, smoking history, age, education, income, and use of psychiatric medications. RESULTS:A total of 3,934 participants (mean (M) ± standard deviation (SD) age=27.6±5.6 years) met inclusion criteria with a mean follow-up interval of 3.2±0.9 years. A 4-class model, which provided the best fit to the EPDS data (mean posterior probability across classes=0.81), produced the following trajectories: (1) stable low (n=2412; 61.1%), (2) increasing severity (n=848; 21.5%), (3) decreasing severity (n=476; 12.1%), and (4) stable high (n=212; 5.4%). Compared to the stable low group, all groups exhibited significantly lower CVH (stable high: β=0.06, p<0.01; decreasing severity: β=0.05, p=0.02; increasing severity: β=0.08 p<0.01). Pairwise comparisons among the three elevated-symptom groups revealed no significant differences in latent CVH (all ps >0.24). DISCUSSION:The longitudinal course of depressive symptoms from pregnancy to 2-7 years post-delivery varied across individuals. Compared to those with consistently low depressive symptoms, individuals with higher severity symptoms at any point all exhibited lower CVH, regardless of the specific trajectory of symptoms. These findings support a life-course perspective in which depressive symptom patterns may represent an early indicator of cardiometabolic vulnerability.

We examined whether severe maternal morbidity (SMM) at delivery was associated with the initiation and duration of breastfeeding among nulliparous individuals in the United States in a secondary analysis from the prospective nuMoM2b-HHS (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be Heart Health Study). Among 6,762 nulliparous individuals, the frequency of any breastfeeding by duration was as follows: 759 (11.2%) breastfed for less than 6 weeks; 1,847 (27.3%) breastfed for 6 weeks to 6 months; and 3,359 (49.7%) breastfed for more than 6 months, and the frequency of exclusive breastfeeding among those with any breastfeeding was 4,653 (85.4%). The frequency of any SMM was 160 (2.4%) and nontransfusion SMM was 124 (1.8%). Breastfeeding initiation did not vary by SMM status. Among those who breastfed, SMM was associated with a lower likelihood of breastfeeding for more than 6 months (adjusted odds ratio [aOR] 0.50; 95% CI, 0.36-0.68) and a lower likelihood of exclusive breastfeeding (aOR 0.60; 95% CI, 0.37-0.98). In a prospective cohort of nulliparous pregnant individuals from across the United States, SMM at delivery was not associated with breastfeeding initiation, but was associated with a significantly lower likelihood of breastfeeding duration and exclusive breastfeeding.

BACKGROUND:Various empirically selected azithromycin dosing regimens are used as part of an antibiotic regimen to prolong latency in the setting of preterm premature rupture of membranes with limited prospective clinical or pharmacologic data to guide dose selection. Azithromycin clears from plasma quickly to concentrate in tissue, thus dosing is based on optimal local concentrations rather than plasma concentration which is the focus of the current study. OBJECTIVE:Compare pharmacokinetic parameters of 1 g once vs 500 mg daily dosing of azithromycin in the setting of preterm premature rupture of membranes and simulate various dosing regimens to identify the optimal regimen that maintains amniotic fluid concentration of azithromycin over the minimum inhibitory concentration of common genitourinary pathogens associated with intraamniotic infection or inflammation. STUDY DESIGN:This is a prospective study of singleton gestations with preterm premature rupture of membranes who received either 1 g once or 500 mg daily x 7 days of azithromycin. Maternal plasma samples were collected predose, 1 to 4 and 12 to 24 hours postdose, and every 24 hours thereafter. Participants in the 500 mg once daily group had plasma samples collected prior to their next dose. Amniotic fluid samples were collected opportunistically in a noninvasive manner by extracting amniotic fluid from sanitary pads. Population pharmacokinetic analysis was performed with Monolix version 2024R1. Because azithromycin efficacy is both time and concentration dependent, various parameters were compared including concentration at 168 hours, area under the curve over time, and percentage of time above the minimum inhibitory concentration of common genitourinary pathogens. Finally, multiple oral dosing regimens were simulated to estimate amniotic fluid exposure over a 7-day period. Data are presented as median and interquartile range. RESULTS:Eighteen participants with 101 plasma and 223 amniotic fluid samples were included in the analysis. A two-compartment model with first-order absorption best described the plasma data. In examining the amniotic fluid data, only vaginal progesterone supplementation in the pregnancy was associated with decreased distribution into amniotic fluid, no other covariate impacted the model. Azithromycin exposure in the first 24 hours was greater with 1 g once (area under the amniotic fluid curve from time 0-24 hours/minimum inhibitory concentration 27.84 [9.01, 71.77] for 1 g once vs 13.84 [4.52, 36.44] for 500 mg daily, P<0.01). Azithromycin concentration by day 7 (27.46 [10.42, 97.85] vs 5.92 [2.07, 21.86] ng/ml, P<0.01) as well as time over minimum inhibitory concentration of common genitourinary pathogens, even at the lowest desired concentration of >20 ng/ml (86.14 [27.87, 98.23] vs 64.66 [0, 99.28] hrs, P<0.01) were greater with daily dosing compared to 1 g once. Simulated dosing regimens suggest that a loading dose followed by daily dosing (1 g once then 500 mg daily for 6 days) or alternate day dosing (2 g once, 1 g days 2 and 4) most rapidly and consistently maintain amniotic azithromycin concentration>60 ng/ml over a 7-day period. CONCLUSION:Administration of 500-mg azithromycin daily x 7 days is superior to 1 g once at maintaining amniotic fluid azithromycin concentrations over the minimum inhibitory concentration of common genitourinary pathogens. The optimal simulated dosing regimen is a loading dose followed by daily dosing or alternate day dosing. Our findings can inform current clinical care and dose selection in future clinical trials.

OBJECTIVE:To evaluate whether cannabis exposure after a first pregnancy was associated with incident hypertension 2-7 years after that pregnancy. METHODS:This was a secondary, cross-sectional analysis of the nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers to Be) Heart Health Study. Nulliparous participants were followed up from the first trimester to an in-person study visit 2-7 years after their pregnancy. The primary exposure was cannabis use after pregnancy, which was detected by having urine positive for THC-COOH (11-nor-9-carboxy-delta-9-tetrahydrocannabinol) metabolite (cutoff 15 ng/mL or higher) at the study visit at 2-7 years. The primary outcome of this analysis was incident hypertension (systolic blood pressure 140 mm Hg or higher or diastolic blood pressure 90 mm Hg or higher) or use of an antihypertensive agent at the time of the follow-up visit at 2-7 years. A multivariable logistic regression model was fitted and adjusted for covariates that were selected a priori, including nicotine exposure assessed at the follow-up visit (measured through serum cotinine levels or self-report), to assess whether cannabis exposure was associated with the occurrence of incident hypertension. RESULTS:Of 4,079 participants, 216 (5.3%) developed hypertension by the study visit at 2-7 years. Neither exposure to cannabis in 406 participants (10.0%) (adjusted odds ratio [AOR] 1.05, 95% CI, 0.63-1.76) nor active nicotine exposure (AOR 1.03, 95% CI, 0.66-1.63) was associated with incident hypertension in multivariable modeling. CONCLUSION:In this population of nulliparous women, cannabis exposure 2-7 years after pregnancy was not associated with incident hypertension after controlling for nicotine exposure and known risk factors measured during the pregnancy.

Background:Hypertensive disorders of pregnancy (HDP) may first be diagnosed antepartum, during labor, or postpartum. We utilized untargeted large-scale proteomics to identify pathways associated with HDP based on timing of onset. Methods:We performed a nested case-control study comparing differential protein expression, from the SomaScan 7K platform, based on timing of onset of HDP (categorized as antepartum, intrapartum, postpartum) versus controls (referent) using first-trimester plasma samples from the NuMoM2b-Heart Health Study, a multi-site prospective cohort that followed nulliparous individuals from the first trimester through postpartum. Associations of individual proteins with timing of onset of HDP, adjusted for co-variates, were assessed using logistic regression q value-based false discovery rates and pathway enrichment and differential expression analysis were conducted. Results:Of 1628 individuals included, 678 had a HDP, of which 67% initially manifested antepartum (AP), 29% intrapartum (IP), and 3% postpartum (PP). After adjusting for co-variates, compared to controls, 698 proteins, 39 proteins, and 144 proteins were differentially expressed in those with HDP according to AP, IP, PP onset, respectively. There was little overlap in individual protein expression based on timing of HDP diagnosis, with pathway enrichment analysis and graphical summary analysis suggesting distinct processes. Specifically, there was downregulation of angiogenic proteins in AP HDP, downregulation of immune-related proteins in IP HDP, and upregulation of complement activation promoting fibrotic and inflammatory changes leading to cardiac dysfunction in PP HDP. Conclusion:There are differences in first-trimester protein expression based on whether HDP first manifests AP, IP or PP. This raises the possibility that there may be distinct mechanistic phenotypes that could uniquely inform diagnostic and therapeutic targets for HDP.

Background: Hypertensive disorders of pregnancy (HDP) may first be diagnosed antepartum, during labor, or postpartum. We utilized untargeted large-scale proteomics to identify pathways associated with HDP based on timing of onset. Methods: We performed a nested case-control study comparing differential protein expression, from the SomaScan 7K platform, based on timing of onset of HDP versus controls (referent) using first-trimester samples from the NuMoM2b-Heart Health Study, a multi-site cohort that followed nulliparous individuals from the first trimester. Associations of proteins with timing of onset of HDP, adjusted for co-variates, were assessed using logistic regression q value-based false discovery rates and pathway enrichment and differential expression analysis were conducted. Results: Of 1628 individuals included, 678 had HDP, of which 67% manifested antepartum (AP), 29% intrapartum (IP), and 3% postpartum (PP). After adjusting for co-variates, compared to controls, 698 proteins, 39 proteins, and 144 proteins were differentially expressed in those with HDP according to AP, IP, PP onset, respectively. There was little overlap in individual protein expression based on timing of HDP. Pathway enrichment and graphical summary analyses suggested distinct processes. Specifically, there was downregulation of angiogenic proteins in AP HDP, downregulation of immune-related proteins in IP HDP, and upregulation of complement activation promoting fibrotic changes leading to cardiac dysfunction in PP HDP. Conclusion: There are differences in first-trimester protein expression based on whether HDP first manifests AP, IP or PP. This raises the possibility that there may be distinct mechanistic phenotypes that could uniquely inform diagnostic and therapeutic targets for HDP.

This cohort study examines the association of adverse pregnancy outcomes and N-terminal pro-brain natriuretic peptide levels years after delivery.

Background: Adverse pregnancy outcomes (APOs) are risk factors for future cardiovascular disease (CVD). APOs are more common among individuals who experience depression during pregnancy, and depression is a well-established CVD risk factor in non-pregnant populations. The purpose of the present study was to evaluate the relationship between depressive symptoms in pregnancy and future CVD risk, and to determine whether this relationship was mediated by APOs. Methods: This secondary analysis of the multisite prospective nuMoM2b-Heart Health Study included 4,050 participants (M age =27.6±5.6 years), with complete longitudinal data for variables from early pregnancy to 2-7 years post-delivery. Participants self-reported depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) at 6-13 (early pregnancy) and 22-29 (mid-pregnancy) weeks of gestation. APOs were collected prospectively and adjudicated and included small-for-gestational-age birth, hypertensive disorders of pregnancy, gestational diabetes mellitus, placental abruption, and preterm birth. CVD risk factors, assessed at 2-7 years after delivery (follow-up interval M =3.2±0.9 years), were modeled as a higher order latent factor indicated by intermediate latent factors: insulin resistance (glucose and insulin), adiposity (waist circumference and BMI), blood pressure (SBP and DBP), and dyslipidemia (triglycerides and HDL cholesterol). Structural equation modeling was used to test whether APOs (present or absent) mediated the relationship between mid-pregnancy EPDS scores and latent CVD risk 2-7 years post-delivery, covarying for EPDS scores in early pregnancy (approximating pre-pregnancy), length of follow-up interval, smoking history, age, education, and income. Results: The model adequately fit the data (CFI=.96; RMSEA=.058; SRMR=.04). The direct effects of APOs ( β =.26, p <.01) and late pregnancy EPDS scores ( β =.13, p <.01) on latent CVD risk were significant. BMI ( r =.16), waist circumference ( r =.15), and HDL cholesterol ( r =-.13) were the CVD risk factors most strongly associated with late pregnancy EPDS scores ( r range=|.04-.16|). The indirect effect of EPDS scores on CVD risk through APOs was not significant ( p >.6). Discussion: Depressive symptoms in mid-pregnancy were associated with higher CVD risk 2-7 years after delivery, but this effect was not mediated by experiencing APOs. Future studies should evaluate whether pregnancy interventions to improve mood reduces subsequent risk of CVD.

Expectant management of preterm pregnancies with hypertensive disorders (HDP), such as preeclampsia (PE), is standard practice for neonatal benefit, although the effects on the maternal cardiovascular (CV) system from longer exposure to endothelial inflammation is uncertain. Latency of expectant management is the time from HDP diagnosis to delivery. Studies from administrative databases suggest a higher rate of adverse CV outcomes several years post-pregnancy with latency >7 days. Using the nuMoM2b-HHS (Nulliparous Pregnancy Outcomes Heart Health Study) cohort, we evaluated the relation between latency in nulliparas expectantly managed with HDP and mean systolic and diastolic blood pressure (BP) 2-7 years post-pregnancy. In the primary study (nuMoM2b), pregnancy diagnoses and outcomes were prospectively ascertained and biospecimens were obtained. We included those with HDP (PE with or without severe features, and gestational HTN) diagnosed <37 weeks. Latency was defined as short (2-7 days) or long (>7 days). We excluded those with chronic hypertension (HTN) or pregestational diabetes at index pregnancy, if exposure or outcome data were missing from the index pregnancy or HHS visit, or if latencies were implausible based on timing of diagnosis and delivery. We used linear regression models to examine the association between latency with BP and markers of CV risk (high-sensitivity CRP (hs-CRP), lipids, HgbA1C, NTproBNP, and ACC/AHA CV risk score) obtained 2-7 years post-pregnancy. We planned a sensitivity analysis of those with early-onset HDP (diagnosis <34 weeks). 150 participants, 32 with short and 118 with long latency, met inclusion criteria (Table 1). BP at HHS follow-up was not different by latency duration (Table 1, Fig 1). hs-CRP was significantly higher in those with long latency, including after adjustment for confounders (age, race, BMI, baseline CV markers, gestational diabetes, small for gestational age infant, and smoking [Fig 2]). The other markers of CV risk were not statistically different between groups [Table 1]. In sensitivity analysis, BP was not different between groups; however, hs-CRP was significantly higher in the longer latency group. In this cohort of prospectively adjudicated pregnancy outcomes, longer latency in those with expectantly managed preterm HDP was not associated with overall differences in CV risk, including BP 2-7 years after a first delivery. The finding of elevated hs-CRP warrants follow-up in a larger cohort.

Most shoulder dystocia (SD) cases do not have associated adverse outcomes. The objective was to assess whether SD relieved with ≥3 maneuvers, compared with fewer, is associated with a higher likelihood of adverse outcomes. The secondary objective was to examine if postpartum hemorrhage is associated with SD managed with ≥3 maneuvers versus fewer.This was a secondary analysis of the assessment of perinatal excellence (APEX) study, an observational cohort of over 115,000 deliveries in 25 U.S. hospitals from 2008 to 2011. We included individuals with singleton, vertex, and nonanomalous fetuses at ≥34 weeks who had SD requiring at least one maneuver. We stratified participants according to if ≥3 maneuvers, versus fewer, were utilized to resolve the SD. The primary outcome was the incidence of a neonatal composite adverse outcome including APGAR <5 at 5 minutes, fetal fractures, intracranial hemorrhage, brachial plexus palsy, facial nerve palsy, hypotension treated, hypoxic-ischemic encephalopathy, or neonatal death. Using modified-Poisson-regression, we calculated adjusted incidence relative risk (aIRR) with 95% confidence intervals (CI).The rate of SD in APEX was 1.9% (2,138/118,422). Of 2,138 cases of SD, 96% met the inclusion criteria. ≥3 maneuvers were utilized in 18.9% (391/2,062) of SD cases. The composite neonatal adverse outcome occurred in 8.1% (168/2,062) of cases, and in adjusted models, the risk for the composite outcome was significantly higher with SD requiring ≥3 maneuvers (15.1%) versus <3 maneuvers (6.5%; aIRR: 2.08; 95% CI: 1.50-2.89). Additionally, APGAR <5 at 5 minutes (aIRR: 4.10; 95% CI: 1.18-14.25), neonatal brachial plexus palsy (aIRR: 2.58; 95% CI: 1.45-4.60), and hypoxic-ischemic encephalopathy (aIRR: 2.83; 95% CI: 1.36 and 5.89) were significantly more likely when ≥3 were used. No significant difference was noted for postpartum hemorrhage (PPH) by number of maneuvers (aIRR: 0.74; 95% CI: 0.44 and 1.21).SD relieved by ≥3 maneuvers, compared with <3, was associated with a 2-fold-increased risk for the composite neonatal adverse outcome, with no difference in risk for PPH. · ≥3 Maneuvers increase neonatal adverse outcomes.. · With ≥3 maneuvers, higher risk of low APGAR and HIE.. · PPH rates similar for ≥3 versus <3 maneuvers..

OBJECTIVE:To assess the efficacy of low-dose aspirin in the prevention of adverse outcomes in low-risk, nulliparous singleton pregnancies. DATA SOURCES:PubMed, Ovid MEDLINE, Scopus, Cochrane Library, clinicaltrials.gov, and ScienceDirect were searched from their inception to August 5, 2023. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:Randomized clinical trials comparing low-dose aspirin with placebo or with no treatment in low-risk nulliparous singleton pregnancies were included. High-risk pregnancies, including prior preterm birth, prior preeclampsia, and those affected by maternal diabetes or chronic hypertension were excluded. DATA APPRAISAL AND SYNTHESIS METHODS:The primary outcome was the incidence of preterm delivery at less than 37 weeks. The summary measures were reported as relative risk (RR) or as mean difference (MD) with a 95% confidence interval (CI). RESULTS:Ten trials, including 27,075 nulliparous low-risk pregnancies, were included. Overall, low-dose aspirin was associated with no significant differences in preterm birth less than 37 weeks (RR 0.90, 95% CI 0.73-1.09) and less than 34 weeks (RR 0.62, 95% CI 0.37-1.05) compared to control. Patients who took 100 mg daily of aspirin prior to 16 weeks had a significantly lower risk of preterm birth at less than 37 weeks (RR: 0.45, 95% CI: 0.35-0.59), as did, to a lower magnitude, those who began aspirin 100 mg daily after 16 weeks (RR: 0.88, 95% CI: 0.80-0.97). Those who took 100 mg daily of aspirin were at a lower risk of preterm birth at less than 37 weeks than those who took between 60 and 81 mg of daily aspirin (RR: 0.39, 95% CI: 0.31-0.48). No statistically significant differences were found in the incidence of hypertensive disorders of pregnancy, perinatal or neonatal death. CONCLUSIONS:Low-dose aspirin at 100 mg daily reduces the incidence of preterm birth at less than 37 weeks in low-risk, nulliparous pregnancies and may be most helpful if initiated prior to 16 weeks. El resumen está disponible en Español al final del artículo.

Postpartum women with hypertensive disorders are routinely discharged on Labetalol, Nifedipine, and Lasix; however, the impact of antihypertensive selection on readmission is not well understood. We performed a retrospective cohort study of all pregnancies at a single institution who delivered from 07/31/2012 to 01/31/2023 who had a hypertensive disorder during pregnancy. Discharge antihypertensive medications were recorded along with other demographic data. Readmission within 42 days was then ascertained for the cohort. Our primary outcome was the readmission rate. Univariate analysis was performed. A total of 11192 pregnancies met study criteria. The average maternal age was 30.1 and the study population was 55.78% white and 34.57% Black. 35.35% of the study cohort received health insurance funded by the government. A total of 491 patients were readmitted within 42 days of discharge, for a total readmission rate of 4.39%. Both Nifedipine and Lasix were associated with a statistically significant decreased risk of readmission, with readmission rates of 2.97% (p=0.04) and 3.45% (p=0.045) respectively. Receipt of labetalol was not associated with a change in readmission rate (5.12%, p=0.174). Discharge on Nifedipine or Lasix was associated with a statistically significant decrease in readmission rate, while receipt of Labetalol did not change readmission rates.

The AVERT PRETERM trial (NCT03151330) evaluated whether screening clinically low-risk pregnancies with a validated maternal blood biomarker test for spontaneous preterm birth (sPTB) risk, followed by preventive treatments for those screening positive, would improve neonatal outcomes compared to a clinically low-risk historical population that had received the usual care. Prospective arm participants with singleton non-anomalous pregnancies and no PTB history were tested for sPTB risk at 191/7–206/7 weeks’ gestation and followed up with after neonatal discharge. Screen-positive individuals (≥16% sPTB risk) were offered vaginal progesterone (200 mg) and aspirin (81 mg) daily, with twice-weekly nurse phone calls. Co-primary outcomes were neonatal morbidity and mortality, measured using a validated composite index (NMI), and neonatal hospital length of stay (NNLOS). Endpoints were assessed using survival analysis and logistic regression in a modified intent-to-treat population comprising screen-negative individuals and screen-positive individuals accepting treatment. Of 1460 eligible participants, 34.7% screened positive; of these, 56.4% accepted interventions and 43.6% declined. Compared to historical controls, prospective arm neonates comprising mothers accepting treatment had lower NMI scores (odds ratio 0.81, 95% CI, 0.67–0.98, p = 0.03) and an 18% reduction in severe morbidity. NNLOS was shorter (hazard ratio 0.73, 95% CI, 0.58–0.92, p = 0.01), with a 21% mean stay decrease among neonates having the longest stays. Sensitivity analyses in the entire intent-to-treat population supported these findings. These results suggest that biomarker sPTB risk stratification and preventive interventions can ameliorate PTB complications in singleton, often nulliparous, pregnancies historically deemed low risk.

Importance A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting. Objective To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix. Design, Setting, and Participants We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded. Interventions Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians. Main Outcome and Measures The primary outcome was delivery or fetal death prior to 37 weeks. Results A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32). Conclusions and Relevance Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality.

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.

BACKGROUND: Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied. OBJECTIVE: This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage. STUDY DESIGN: This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups. RESULTS: A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (P<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (P<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (P<.001). No difference in the need for additional uterotonics (P=.26) or the need for postoperative parental iron (P=.18) was noted. No woman was transfused in either group. CONCLUSION: High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.