Matthew K. Hoffman

Introduction: To evaluate the association between the use of antihypertensive medications during the peripartum period among individuals with hypertensive disorders of pregnancy (HDP) and the risk of incident hypertension in the years after pregnancy. Methods: We conducted a secondary analysis of the nuMoM2b‐Heart Health Study (HHS), a multi‐site prospective cohort study that enrolled nulliparous pregnant individuals in their first trimester who were followed during pregnancy and subsequently underwent a cardiovascular screening visit (HHS visit) 2‐7 years after delivery. Individuals without chronic hypertension who developed HDP (gestational hypertension, preeclampsia without severe features, or preeclampsia with severe features) were included. The exposure was treatment with antihypertensive medication (oral or intravenous) during the pregnancy episode (pregnancy through 6 weeks postpartum). The primary outcome was stage 1 (blood pressure [BP] ≥130/80 mmHg) and stage 2 hypertension (BP ≥140/90 mmHg or use of antihypertensive medications) at the HHS visit, which was ascertained following a standardized research protocol. Multinomial logistic regression models estimated the association of antihypertensive medication use with incident hypertension, adjusted for co‐variates. Results: Among 4484 individuals who underwent a follow‐up visit (mean follow‐up: 3.2 ± 1.8 years), 1007 (22.5%) had HDP during the nuMoM2b pregnancy and were included. Of those, 132 (13%) were treated with an antihypertensive medication during the pregnancy episode. Treated individuals had higher systolic (119 ± 13 vs. 114 ± 11 mmHg, p < 0.001) and diastolic (80 ± 12 vs. 74 ± 10 mmHg, p < 0.001) BP at follow‐up. In multivariable regression, those treated with antihypertensive medications had 2.5‐fold (95% confidence interval [CI], 1.6–4.1) greater odds of stage 1 hypertension and 4.3‐fold (95% CI, 2.5–7.3) greater odds of stage 2 hypertension compared to those with HDP who were not treated with antihypertensive medications. Conclusion: Among nulliparous individuals with HDP, treatment with antihypertensive medication during or immediately after pregnancy is associated with a two‐ to fourfold higher odds of incident hypertension in the years postpartum, independent of HDP type. The use of antihypertensive medication in the peripartum period may serve as an easily ascertainable risk marker to identify individuals at heightened risk of persistent hypertension who may benefit from targeted postpartum surveillance and intervention.

Introduction: To develop and validate a single‐nucleotide polymorphism (SNP)‐based noninvasive prenatal cell‐free DNA (cfDNA) screening algorithm capable of identifying the cfDNA signal of the living fetus in vanishing twin (VT) pregnancies and assessing that twin's aneuploidy risk. Methods: Prospective study enrolling participants ≥18 years old at ≥9 weeks’ gestation with an ultrasound‐confirmed VT at 21 US sites (August 2021 to August 2023). The study protocol specified SNP‐based cfDNA screening at enrollment and at two additional 3‐week intervals. Neonatal buccal swabs evaluated the SNP profile of the living fetus. Cases lost to follow‐up and with missing samples were excluded. Using SNP‐based technology, an algorithm to identify the living fetus was developed based on the number of fetoplacental cfDNA signals and individual fetal fraction measurements. Concordance between cfDNA in maternal plasma and newborn buccal‐swab SNP profiles was used to validate the algorithm in correctly identifying the living fetus. Common aneuploidies and fetal sex were determined for the living fetus. Results: Of 136 participants enrolled, 106 met criteria for the final analysis; 45 for development and 61 for validation. In the validation cohort, median gestational age was 10.7 weeks (range: 8.0–16.1 weeks) at ultrasound diagnosis of a VT. In 93.4% of validation cases, the algorithm identified the living fetus and gave an aneuploidy result; 90.2% within the first two blood draws. At the time the living fetus was identified, 39 samples had two fetoplacental signals and 18 had one. Aneuploidy results included 56 low‐risk and one high‐risk result for trisomy 21. Neonatal buccal swabs confirmed that the VT algorithm correctly identified the living twin and gave a correct aneuploidy result in 57/57 cases (100%; 95% confidence interval [CI]: 93.5%, 100.0%). Among 29 participants with all three blood draws and two fetoplacental signals at enrollment, two signals persisted in 93.1% at the second blood draw and 72.4% at the third. Conclusions: The SNP‐based algorithm accurately identified the living fetus in VT pregnancies in this small study. Aneuploidy risk assessment was validated in all cases where the cfDNA signal for the living twin was identified, though these findings should be interpreted with caution given the limited sample size. Trial registration: ClinicalTrials.gov Identifier: NCT05004337

Introduction: Data have demonstrated decreased time in the hospital and improved patient satisfaction when using outpatient cervical ripening with a Foley catheter as compared to routine in‐hospital induction. An ongoing multisite trial (the COMFORT trial) is evaluating the impact of outpatient ripening on cesarean delivery, maternal and neonatal morbidity rates. Here, we aimed to characterize provider and organizational level determinants of implementation related to outpatient cervical ripening with a Foley catheter during the COMFORT trial. Methods: This sequential mixed‐methods study (quan‐ > QUAL; December 2022 to January 2025) was embedded into an ongoing five‐site randomized clinical trial comparing outpatient versus inpatient cervical ripening. Prior to trial initiation, surveys (quan) were distributed to obstetric clinicians at all sites. The survey collected demographics, Foley placement experience, perceived acceptability, and feasibility of outpatient Foley via validated measures [Likert; total 4–20]. One year into the trial, clinician focus groups (QUAL) assessed barriers, facilitators, and sustainability of outpatient Foley, guided by the Consolidated Framework for Implementation Research 2.0 and coded in an integrated approach. Results: A total of 396 clinicians (64% physicians, 22% nurses, 10% certified nurse midwives [CNMs], 4% nurse practitioners [NPs]/physician assistants [PAs]) completed the pre‐trial survey; 29.2% had previously used outpatient ripening. Acceptability (19/20 interquartile range [IQR] [16–20]) and feasibility (16/20 IQR [15–20]) were high overall but varied by site ( p = 0.003; p = 0.006, respectively). Factors independently associated with acceptability included site, clinician role (physicians/CNMs vs. nurses), and clinician gender. As a result, focus groups were divided by site and role to elicit site‐specific barriers and facilitate open discussion among nurses without physicians/CNMs present. Twelve focus groups ( n = 33) identified facilitators including belief in the evidence/safety and benefit, as well as leadership support. Barriers included concerns about timely hospital return, perceived patient discomfort, and operational constraints (e.g., space and staffing). In response, participants discussed systematic strategies to promote sustainability, several already enacted, such as standardized patient education and workflow solutions. No meaningful differences in identified barriers, facilitators, or suggested strategies were noted by site or clinician role. Conclusion: This work identified key determinants influencing the implementation of outpatient cervical ripening with a Foley catheter. Findings (1) allowed for real‐time adaptations to intervention workflow and utilization of new implementation strategies during the course of the multisite trial, and (2) can be utilized to drive success for current and future sites implementing outpatient Foley cervical ripening clinically.

Introduction: Following diagnosis of a short cervix from 16 through 23 weeks there is considerable variation in clinical practice. We sought to evaluate the association of patient sociodemographic factors with variation in clinical management following diagnosis of a short cervix. Methods: This was a non‐prespecified secondary analysis of the randomized Trial of Cervical Pessary for Short Cervix in Singleton Pregnancies (TOPS), in which individuals with singleton pregnancies with a cervical length (CL) ≤20 mm were randomized to either a pessary or usual care. We assessed recommendations for vaginal progesterone, additional CL surveillance, pelvic rest, bed rest, and cerclage. For individuals enrolled in the trial, additional CL assessment and cerclage were discouraged in the absence of significant cervical dilation; activity modification and vaginal progesterone were at provider's discretion. Sociodemographic factors assessed were self‐reported race and ethnicity, marital status, employment status, years of education, and type of insurance. Multivariable regression models examined the association between each sociodemographic factor and management, adjusting for other sociodemographic factors, CL at enrollment, clinical center, and treatment arm; odds ratios (ORs) and 95% confidence intervals (CIs) were determined. Results: Of the 446 patients (82% of 544 enrolled in TOPS) with at least one post enrollment visit, 95.5% received vaginal progesterone, 28.0% had at least one additional CL assessment, 55.8% were placed on pelvic rest, 19.5% on activity restriction, and 7.4% underwent cerclage. The high rate of vaginal progesterone usage precluded evaluation of association with sociodemographic factors. Non‐Hispanic Black and Hispanic patients had lower odds of repeat CL assessment compared with Non‐Hispanic White patients (adjusted OR [aOR], 0.47; 95% CI, 0.24, 0.91; aOR, 0.45; 95% CI, 0.21, 0.99, respectively). No other sociodemographic factors were associated with repeat CL. Patients with private insurance, but no other factor, had higher odds of pelvic rest being recommended (aOR, 2.08; 95% CI, 1.25, 3.45). None of the examined sociodemographic factors were associated with recommendations for bed rest or cerclage. Conclusion: Following diagnosis of a short cervix, vaginal progesterone is prescribed for nearly all patients. Non‐Hispanic Black and Hispanic patients were less likely to have a repeat CL assessment following diagnosis of a short cervix and those with private insurance were more likely to have pelvic rest recommended. Variation in the frequency of these interventions may reflect how sociodemographic and socially constructed factors can affect clinical decision making and implementation of interventions in the absence of definitive guidance. Trial registration: ClinicalTrials.gov Identifier: NCT02901626.

Currently birth outcomes in the United States lag other industrialized countries and are driven predominantly by adverse pregnancy outcomes including preeclampsia, spontaneous preterm birth, stillbirth and fetal growth restriction. In aggregate these conditions are termed adverse pregnancy outcomes (APOs) and are complex in their origin, but largely reflect placentally mediated conditions that begin in early pregnancy. Low-dose aspirin (LDA) has been shown to lower the risk of APOs, but questions about the optimal dose, patient population to receive it, and barriers to prescribing and adherence have limited the impact of LDA on a population level. Multiple investigations unfortunately have shown that uptake is low and often biased in its provision. To address these inequities in care, the Delaware Perinatal Quality Collaborative (DPQC) organized efforts around standardizing screening all patients, providing hospital level feedback and enhanced patient education. With this effort, the rate of appropriate LDA prescription increased from 10% to 65%. Further studies and thoughtful conversations around additional barriers to care must be addressed jointly by researchers, providers, public health officials, patients and the community at large if the full promise shown in randomized controlled trials is to be realized.

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.