Intrapartum electronic fetal heart rate monitoring to predict acidemia at birth with the use of deep learning.

BACKGROUND: EFM is used in the vast majority of US hospital births, but has significant limitations in achieving its intended goal of preventing intrapartum hypoxic-ischemic injury. Novel deep learning techniques can improve complex data processing and pattern recognition in medicine. OBJECTIVE: We sought to apply deep learning approaches to develop and validate a model to predict fetal acidemia from EFM data. STUDY DESIGN: The database was created using intrapartum EFM data from 2006-2020 from a large, multi-site academic health system. Data was divided into training and testing sets with equal distribution of acidemic cases. Several different deep learning architectures were explored.The primary outcome was umbilical artery acidemia, investigated at four clinically meaningful thresholds: 7.20, 7.15, 7.10, and 7.05, along with base excess. Receiver operating characteristic (ROC) curves were generated with area under the curve (AUROC) assessed to determine the performance of the models. External validation occurred utilizing a publicly available Czech database of EFM data. RESULTS: A total of 124,777 EFM files were available; 77,132 had <30% missingness in the last 60 minutes of the EFM tracing; 21,041 were matched to a corresponding umbilical cord gas result, 10,182 of which were timestamped within 30 minutes of the last EFM reading and comprised the final dataset. The prevalence of the outcome in the data was 20.9% with pH <7.2, 9.1% <7.15, 3.3% <7.10, and 1.3% <7.05. The best performing model achieved an AUROC of 0.85 at a pH threshold of <7.05. When predicting the joint outcome of both pH <7.05 and base excess <-10 meq/L, it achieved an AUROC of 0.89. When predicting both pH <7.20 and base excess <-10 meq/L, it achieved an AUROC of 0.87. At pH <7.15 and a PPV of 30%, the model achieved a sensitivity of 90% and a specificity of 48%. CONCLUSION: Application of deep learning methods to intrapartum EFM analysis achieves promising performance in predicting fetal acidemia. This technology could potentially help improve the accuracy and consistency of EFM interpretation.

Adverse Pregnancy Outcomes and Predicted 30-Year Risk of Maternal Cardiovascular Disease 2-7 Years After Delivery.

OBJECTIVE: To determine whether adverse pregnancy outcomes are associated with a higher predicted 30-year risk of atherosclerotic cardiovascular disease (CVD; ie, coronary artery disease or stroke). METHODS: This was a secondary analysis of the prospective Nulliparous Pregnancy Outcomes Study-Monitoring Mothers-to-Be Heart Health Study longitudinal cohort. The exposures were adverse pregnancy outcomes during the first pregnancy (ie, gestational diabetes mellitus [GDM], hypertensive disorder of pregnancy, preterm birth, and small- and large-for-gestational-age [SGA, LGA] birth weight) modeled individually and secondarily as the cumulative number of adverse pregnancy outcomes (ie, none, one, two or more). The outcome was the 30-year risk of atherosclerotic CVD predicted with the Framingham Risk Score assessed at 2-7 years after delivery. Risk was measured both continuously in increments of 1% and categorically, with high predicted risk defined as a predicted risk of atherosclerotic CVD of 10% or more. Linear regression and modified Poisson models were adjusted for baseline covariates. RESULTS: Among 4,273 individuals who were assessed at a median of 3.1 years after delivery (interquartile range 2.5-3.7), the median predicted 30-year atherosclerotic CVD risk was 2.2% (interquartile range 1.4-3.4), and 1.8% had high predicted risk. Individuals with GDM (least mean square 5.93 vs 4.19, adjusted ß=1.45, 95% CI, 1.14-1.75), hypertensive disorder of pregnancy (4.95 vs 4.22, adjusted ß=0.49, 95% CI, 0.31-0.68), and preterm birth (4.81 vs 4.27, adjusted ß=0.47, 95% CI, 0.24-0.70) were more likely to have a higher absolute risk of atherosclerotic CVD. Similarly, individuals with GDM (8.7% vs 1.4%, adjusted risk ratio [RR] 2.02, 95% CI, 1.14-3.59), hypertensive disorder of pregnancy (4.4% vs 1.4%, adjusted RR 1.91, 95% CI, 1.17-3.13), and preterm birth (5.0% vs 1.5%, adjusted RR 2.26, 95% CI, 1.30-3.93) were more likely to have a high predicted risk of atherosclerotic CVD. A greater number of adverse pregnancy outcomes within the first birth was associated with progressively greater risks, including per 1% atherosclerotic CVD risk (one adverse pregnancy outcome: 4.86 vs 4.09, adjusted ß=0.59, 95% CI, 0.43-0.75; two or more adverse pregnancy outcomes: 5.51 vs 4.09, adjusted ß=1.16, 95% CI, 0.82-1.50), and a high predicted risk of atherosclerotic CVD (one adverse pregnancy outcome: 3.8% vs 1.0%, adjusted RR 2.33, 95% CI, 1.40-3.88; two or more adverse pregnancy outcomes: 8.7 vs 1.0%, RR 3.43, 95% CI, 1.74-6.74). Small and large for gestational age were not consistently associated with a higher atherosclerotic CVD risk. CONCLUSION: Individuals who experienced adverse pregnancy outcomes in their first birth were more likely to have a higher predicted 30-year risk of CVD measured at 2-7 years after delivery. The magnitude of risk was higher with a greater number of adverse pregnancy outcomes experienced.

Using Longitudinal Twitter Data for Digital Epidemiology of Childhood Health Outcomes: An Annotated Data Set and Deep Neural Network Classifiers.

We manually annotated 9734 tweets that were posted by users who reported their pregnancy on Twitter, and used them to train, evaluate, and deploy deep neural network classifiers (F1-score=0.93) to detect tweets that report having a child with attention-deficit/hyperactivity disorder (678 users), autism spectrum disorders (1744 users), delayed speech (902 users), or asthma (1255 users), demonstrating the potential of Twitter as a complementary resource for assessing associations between pregnancy exposures and childhood health outcomes on a large scale.

Pregnancy-related cardiac outcomes among patients with congenital heart disease after formalization of a cardio-obstetrics program.

BACKGROUND: The prevalence of pregnant patients with congenital heart disease (CHD) is increasing, and these patients are at high risk for cardiac morbidity. OBJECTIVE: This study aimed to examine the pregnancy outcomes in patients with congenital heart disease before and after the establishment of formal cardio-obstetrics collaboration between adult congenital heart disease and maternal-fetal medicine programs. STUDY DESIGN: This was a retrospective cohort study of pregnant patients with congenital heart disease from 2002 to 2020 at a single urban academic institution in the United States. This study included patients with a singleton pregnancy who continued a pregnancy beyond 20 weeks of gestation. The primary outcome was a composite adverse maternal cardiac outcome, compared before (2002-2010) and after (2011-2020) the program. The secondary outcomes included gestational age at delivery, mode of delivery, rate of labor induction, use of diuresis after delivery, and a composite maternal morbidity outcome. RESULTS: The number of pregnant patients with congenital heart disease increased after formalization of the cardio-obstetrics program (200 [postprogram group] vs 84 [preprogram group]; 0.48% of all deliveries in the postprogram group vs 0.25% of all deliveries in the preprogram group; P<.001). The postprogram group was more likely to undergo labor induction than the preprogram group (126 [63%] vs 34 [41%], respectively; P<.001). There were fewer patients in the postprogram group than in the preprogram group who were New York Heart Association class II to IV (23 [12%] vs 17 [22%], respectively; P=.04) or with systemic ventricular dysfunction (8 [4%] vs 12 [16%], respectively; P=.001). There was no difference in the primary outcome (38 [19%] in the postprogram group vs 14 [17%] in the preprogram group; P=.64), even after adjusting for confounders, including New York Heart Association class >I and systemic ventricular dysfunction (adjusted odds ratio, 2.3; 95% confidence interval, 0.96-5.4). Patients in the postprogram group were more likely to receive diuresis after delivery than patients in the preprogram group, even in the absence of heart failure or pulmonary edema (9 [4.5%] vs 0 [0.0%], respectively; P=.04). CONCLUSION: In the period after the establishment of a formal cardio-obstetrics program between adult congenital heart disease and maternal-fetal medicine, the number of patients with congenital heart disease delivering at our institution increased significantly. Overall, fewer patients entered pregnancy with advanced-stage heart failure or systemic ventricular dysfunction, possibly suggesting improved prepregnancy cardiac care or improved preconception counseling. Composite maternal cardiac outcomes were similar, but the rates of postpartum diuresis increased significantly, suggesting increased attention to volume status in the postpartum period. Formalized collaboration between congenital heart disease and maternal-fetal medicine may help better optimize patients' care before conception, during pregnancy, and after delivery.

Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.

Are Racial Disparities in Cesarean Due to Differences in Labor Induction Management?

OBJECTIVE: While there are known racial disparities in cesarean delivery (CD) rates, the exact etiologies for these disparities are multifaceted. We aimed to determine if differences in induction of labor (IOL) management contribute to these disparities. STUDY DESIGN: This retrospective cohort study evaluated all nulliparous patients with an unfavorable cervix and intact membranes who underwent IOL of a term, singleton gestation at a single institution from October 1, 2018, to September 30, 2020. IOL management was at clinician discretion. Patients were classified as Black, Indigenous, and People of Color (BIPOC) or White based on self-report. Overall rates of CD were compared for BIPOC versus White race. Chart review then evaluated various IOL management strategies as possible contributors to differences in CD by race. RESULTS: Of 1,261 eligible patients, 915 (72.6%) identified as BIPOC and 346 (27.4%) as White. BIPOC patients were more likely to be younger (26 years interquartile range (IQR) [22-30] vs. 32 years IQR [30-35], p < 0.001) and publicly insured (59.1 vs. 9.9%, p < 0.001). Indication for IOL and modified Bishop score also differed by race (p < 0.001; p = 0.006). There was 40% increased risk of CD for BIPOC patients, even when controlling for confounders (30.7 vs. 21.7%, p = 0.001; adjusted relative risk (aRR) 1.41, 95% confidence interval (CI) [1.06-1.86]). Despite this difference in CD, there were no identifiable differences in IOL management prior to decision for CD by race. Specifically, there were no differences in choice of cervical ripening agent, cervical dilation at or time to amniotomy, use and maximum dose of oxytocin, or dilation at CD. However, BIPOC patients were more likely to undergo CD for fetal indications and failed IOL. CONCLUSION: BIPOC nulliparas are 40% more likely to undergo CD during IOL than White patients within our institution. These data suggest that the disparity is not explained by differences in IOL management prior to cesarean, indicating that biases outside of induction management may be important to target to reduce CD disparities. KEY POINTS: · The etiologies for racial disparities in cesarean are likely multifaceted.. · In this work, there were no differences by race in measures of labor induction management.. · Biases outside of induction management during labor may be targeted to reduce CD disparities..

Communication and Birth Experiences Among Black Birthing People Who Experienced Preterm Birth.

PURPOSE: Physically or psychologically distressing birth experiences can influence postpartum health, parenting efficacy, and future pregnancy plans. Communication deficits contribute to negative birth experiences. This qualitative analysis explored themes related to communication and negative birth experiences among Black birthing people who experienced preterm birth. METHODS: We conducted qualitative interviews with non-Hispanic Black, English language-proficient birthing people with Medicaid-insured preterm infants. Interviews were designed to explore experiences with health care access and well-being after birth. Interviews were audio recorded, transcribed, and coded following an integrated approach where we applied a priori codes and captured emergent themes from the data. RESULTS: We interviewed 30 participants from October 2018 to July 2021. Median gestational age at birth was 30 weeks (range 22-36 weeks). Interviews occurred a median of 7 months postpartum (range 2-34 months). Themes emerged related to negative birth experiences and communication: (1) communication gaps during urgent or emergent intrapartum procedures contributed to negative birth experiences; (2) postpartum opportunities to share birth experiences, particularly with peers, sometimes mitigated the psychological consequences of negative birth experiences; (3) participants did not consistently discuss concerns about future pregnancy risk related to negative birth experiences with clinical teams. CONCLUSIONS: Themes from this sample of Black birthing people who experienced preterm birth suggest 3 ways health systems might intervene to improve communication to mitigate the consequences of negative birth experiences. Improvement efforts in these areas may improve postpartum health, future pregnancy outcomes, and long-term health.

Acceptability of Dyad Care Management After Preterm Birth: A Qualitative Study.

OBJECTIVES: Care management programs for medically complex infants interact with parents after complicated pregnancies, when gaps in maternal health care are well documented. These care managers may have the relationships and skills to promote postpartum and interconception health and health care access. It is unknown whether expanding these care management models to address maternal needs would be acceptable. METHODS: We conducted qualitative interviews with women with a history of preterm birth and clinicians. For women with a history of preterm birth, additional inclusion criteria were Medicaid-insured infant in one health system and English proficiency. We purposively oversampled women whose infants received care management. Clinicians worked in two geographically adjacent health systems. Interviews explored priorities after preterm birth and perceived acceptability of mother-infant dyad care management. Interviews were audio recorded, transcribed, and coded following an integrated approach in which we applied a priori codes and captured emergent themes. RESULTS: We interviewed 33 women (10/2018-7/2021) and 24 clinicians (3/2021-8/2021). Women were predominantly non-Hispanic Black, and 15 had infants receiving care management. Clinicians included physicians, nurses, and social workers from Pediatrics, Obstetrics, and Family Medicine. Subgroups converged thematically, finding care management acceptable. Tailoring programs to address stress and sleep, emphasizing care managers with strong interpersonal skills and shared experiences with care management users, and program flexibility would contribute to acceptability. CONCLUSIONS FOR PRACTICE: Dyad care management after preterm birth is acceptable to potential program end-users and clinicians. Dyad health promotion may contribute to improved birth outcomes, infant, and parent health.

Clinical implications of crown-rump length discordance at 11 to 14 weeks in dichorionic twins.

BACKGROUND: Crown-rump length discordance, defined as ≥10% discordance, has been investigated as an early sonographic marker of subsequent growth abnormalities and is associated with an increased risk of fetal loss in twin pregnancies. Previous studies have not investigated the prevalence of fetal aneuploidy or structural anomalies in twins with discordance or the independent association of crown-rump length discordance with adverse perinatal outcomes. Moreover, data are limited on cell-free DNA screening for aneuploidy in dichorionic twins with discordance. OBJECTIVE: This study aimed to evaluate whether crown-rump length discordance in dichorionic twins between 11 and 14 weeks of gestation is associated with a higher risk of aneuploidy, structural anomalies, or adverse perinatal outcomes and to assess the performance of cell-free DNA screening in dichorionic twin pregnancies with crown-rump length discordance. STUDY DESIGN: This was a secondary analysis of a multicenter retrospective cohort study that evaluated the performance of cell-free DNA screening for the common trisomies in twin pregnancies from December 2011 to February 2020. For this secondary analysis, we included live dichorionic pregnancies with crown-rump length measurements between 11 and 14 weeks of gestation. First, we compared twin pregnancies with discordant crown-rump lengths with twin pregnancies with concordant crown-rump lengths and analyzed the prevalence of aneuploidy and fetal structural anomalies in either twin. Second, we compared the prevalence of a composite adverse perinatal outcome, which included preterm birth at <34 weeks of gestation, hypertensive disorders of pregnancy, stillbirth or miscarriage, small-for-gestational-age birthweight, and birthweight discordance. Moreover, we assessed the performance of cell-free DNA screening in pregnancies with and without crown-rump length discordance. Outcomes were compared with multivariable regression to adjust for confounders. RESULTS: Of 987 dichorionic twins, 142 (14%) had crown-rump length discordance. The prevalence of aneuploidy was higher in twins with crown-rump length discordance than in twins with concordance (9.9% vs 3.9%, respectively; adjusted relative risk, 2.7; 95% confidence interval, 1.4-4.9). Similarly, structural anomalies (adjusted relative risk, 2.5; 95% confidence interval, 1.4-4.4]) and composite adverse perinatal outcomes (adjusted relative risk, 1.2; 95% confidence interval, 1.04-1.3) were significantly higher in twins with discordance. A stratified analysis demonstrated that even without other ultrasound markers, there were increased risks of aneuploidy (adjusted relative risk, 3.5; 95% confidence interval, 1.5-8.4) and structural anomalies (adjusted relative risk, 2.7; 95% confidence interval, 1.5-4.8) in twins with CRL discordance. Cell-free DNA screening had high negative predictive values for trisomy 21, trisomy 18, and trisomy 13, regardless of crown-rump length discordance, with 1 false-negative for trisomy 21 in a twin pregnancy with discordance. CONCLUSION: Crown-rump length discordance in dichorionic twins is associated with an increased risk of aneuploidy, structural anomalies, and adverse perinatal outcomes, even without other sonographic abnormalities. Cell-free DNA screening demonstrated high sensitivity and negative predictive values irrespective of crown-rump length discordance; however, 1 false-negative result illustrated that there is a role for diagnostic testing. These data may prove useful in identifying twin pregnancies that may benefit from increased screening and surveillance and are not ascertained by other early sonographic markers.

Association Between COVID-19 During Pregnancy and Preterm Birth by Trimester of Infection: A Retrospective Cohort Study Using Longitudinal Social Media Data.

Background: Preterm birth, defined as birth at <37 weeks of gestation, is the leading cause of neonatal death globally and, together with low birthweight, the second leading cause of infant mortality in the United States. There is mounting evidence that COVID-19 infection during pregnancy is associated with an increased risk of preterm birth; however, data remain limited by trimester of infection. The ability to study COVID-19 infection during the earlier stages of pregnancy has been limited by available sources of data. The objective of this study was to use self-reports in large-scale, longitudinal social media data to assess the association between trimester of COVID-19 infection and preterm birth. Methods: In this retrospective cohort study, we used natural language processing and machine learning, followed by manual validation, to identify pregnant Twitter users and to search their longitudinal collection of publicly available tweets for reports of COVID-19 infection during pregnancy and, subsequently, a preterm birth or term birth (i.e., a gestational age ≥37 weeks) outcome. Among the users who reported their pregnancy on Twitter, we also identified a 1:1 age-matched control group, consisting of users with a due date prior to January 1, 2020-that is, without COVID-19 infection during pregnancy. We calculated the odds ratios (ORs) with 95% confidence intervals (CIs) to compare the overall rates of preterm birth for pregnancies with and without COVID-19 infection and by timing of infection: first trimester (weeks 1-13), second trimester (weeks 1427), or third trimester (weeks 28-36). Results: Through August 2022, we identified 298 Twitter users who reported COVID-19 infection during pregnancy, a preterm birth or term birth outcome, and maternal age: 94 (31.5%) with first-trimester infection, 110 (36.9%) second-trimester infection, and 95 (31.9%) third-trimester infection. In total, 26 (8.8%) of these 298 users reported preterm birth: 8 (8.5%) were infected during the first trimester, 7 (6.4%) were infected during the second trimester, and 12 (12.6%) were infected during the third trimester. In the 1:1 age-matched control group, 13 (4.4%) of the 298 users reported preterm birth. Overall, the risk of preterm birth was significantly higher for pregnancies with COVID-19 infection compared to those without (OR 2.1, 95% CI 1.06-4.16). In particular, the risk of preterm birth was significantly higher for pregnancies with COVID-19 infection during the third trimester (OR 3.17, CI 1.39-7.21). Conclusion: The results of our study suggest that COVID-19 infection particularly during the third trimester is associated with an increased risk of preterm birth.

Integrating Care for Mother-Infant Dyads After Preterm Birth: A Qualitative Study of Clinician Perspectives on Feasibility.

Objective: There are gaps in receipt of maternal preventive services in the interconception period. Yet mother-infant dyads have frequent health care visits. Health systems have opportunities to better capitalize on existing visits to address dyad needs, but this possibility has not been fully explored. Methods: In this qualitative study we conducted semistructured interviews with clinical team members involved with birthing parents or infants after preterm birth. We conducted snowball sampling from teams in pediatrics, obstetrics, and family medicine at two geographically adjacent health systems. Interviews explored perspectives on existing barriers and facilitators to integrating dyad care across adult and infant teams. Interviews were audio-recorded, professionally transcribed, and coded using an integrated approach. Results: We interviewed 24 physicians, nurses, midwives, and social workers (March-November 2021). Participants identified barriers to integrated care including infrequent communication between clinical teams, which was generalizable to care of the birthing parent or infant as individuals, and additional barriers related to privacy, credentialing, and visit design that were specific to dyad care. To improve integration of dyad care, clinicians proposed adapting a variety tools and procedures currently used in their practices, including electronic health record tools for communication, dedicated roles to support communication or navigation, centralized information on resources for dyad care, referral protocols, identifying dyads for proactive outreach, and opportunities for clinicians to connect face-to-face about shared patients or families. Conclusions: Clinicians believe existing health care structures and processes can be adapted to address current substantial barriers to integrated dyad care.

A Simple Intervention to Improve Equity in Obstetric Research.

Introduction: To evaluate if a simple intervention, including formation of a Research Equity Committee and a dashboard detailing study approach and enrollment statistics by race, could improve equitable inclusion in obstetric research. Methods: Our intervention had four components: (1) research personnel submitted dashboards every 3 months to the Research Equity Committee; (2) approach and enrollment by race were compared with expected racial breakdown; (3) study teams with rates of approach and/or enrollment of black birthing people below goal met with the committee for root cause analysis (RCA) and action planning; (4) all dashboards, RCAs, and action plans were presented at 3-month intervals. We prospectively evaluated the impact of this intervention on the inclusion of self-reported black birthing people in actively enrolling obstetrical studies at an academic university from July 2021 to June 2022. Results: Seven qualifying prospective studies submitted 23 equity dashboards, which encompassed 692 patients. Six RCAs and action planning were held. Themes of developed action plans included: (1) standardizing how, when, and which patients to approach to eliminate approach bias, (2) standardized scripts for patient recruitment, and (3) study expansion to more diverse clinics. All four studies that underwent an RCA demonstrated improvements after the intervention; however, only one study demonstrated a statistically significant increase in approach (p=0.002) and enrollment (p=0.02) of black birthing people across the study period. Discussion and Health Equity Implications: A simple intervention can improve approach and enrollment of black birthing people in obstetric research.

The Relationship between Gestational Weight Gain and Cesarean Delivery among Patients undergoing Induction of Labor.

OBJECTIVE: This study aimed to determine the impact of pregnancy weight gain above National Academy of Medicine (NAM) guidelines on cesarean delivery rates following induction. STUDY DESIGN: This is a secondary analysis of a prospective cohort study of patients who underwent induction at a single tertiary care center between July 2017 and July 2019. Included in the primary study were patients undergoing term (≥37 weeks) labor induction with a singleton gestation, intact membranes, and unfavorable cervical examination (Bishop score of ≤6 and cervical dilation ≤ 2 cm). Eligibility for this analysis was limited to patients with a documented prenatal body mass index (BMI) < 20 weeks' gestation. The primary exposure was gestational weight gain greater than NAM guidelines (WGGG) for a patient's initial BMI category. The primary outcome was cesarean delivery for any indication. RESULTS: Of 1,610 patients included in the original cohort, 1,174 (72.9%) met inclusion criteria for this analysis and 517 (44.0%) of these had weight gain above NAM guidelines. Of the entire cohort, 60.0% were Black and 52.7% had private insurance. In total, 160 patients (31%) with WGGG underwent cesarean compared with 127 patients (19.3%) without WGGG (p < 0.001), which equates to a 59% increased odds of cesarean when controlling for initial BMI category, parity, gestational diabetes, and indication for induction (Adjusted Odds Ratio [aOR] 1.58, 95% confidence interval [CI] 1.17-2.12). Among only nulliparous patients, WGGG was associated with an increased odds of cesarean (26.4 vs. 38.2%, aOR 1.50, 95% CI 1.07-2.10). In multiparous patients, however, there was no difference in cesarean between those with and without WGGG (8.8 vs. 14.1%, aOR 1.85, 95% CI 0.96-3.58). CONCLUSION: This study demonstrates that weight gain above NAM guidelines is associated with more than a 50% increased odds of cesarean. Patients should be informed of this association as gestational weight gain may be a modifiable risk factor for cesarean delivery. KEY POINTS: · Weight gain above NAM guidelines was associated with a 59% increased odds of cesarean delivery.. · Nulliparous patients with weight gain above NAM guidelines are at higher risk of cesarean delivery.. · No difference in cesarean delivery among multiparous patients regardless of gestational weight gain..

Association between intracervical Foley balloon and clinical chorioamnionitis among patients with group B streptococcus colonization undergoing induction with standardized labor management.

BACKGROUND: Intracervical Foley balloons are commonly used for cervical ripening, but there has been a historical concern regarding an increased risk of clinical chorioamnionitis with Foley balloon use in patients with group B streptococcus. OBJECTIVE: This study aimed to determine whether intracervical Foley balloon use in patients with group B streptococcus is associated with an increased risk of clinical chorioamnionitis. STUDY DESIGN: This was a secondary analysis of a randomized controlled trial Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial that compared cervical ripening agents within a standardized labor protocol. Foley balloon (alone, with oxytocin, or with misoprostol) was compared with misoprostol only to evaluate the primary outcome of clinical chorioamnionitis, defined based on the American College of Obstetricians and Gynecologists guidelines. Patients with a term, singleton pregnancy with intact membranes and an unfavorable cervix (Bishop score of ≤6 and dilation ≤2 cm) and a known group B streptococcus status were included. The secondary outcomes included a composite postpartum maternal infectious outcome consisting of any occurrence of endometritis, wound infection, postpartum urinary tract infection, or maternal sepsis; additional secondary outcomes included neonatal outcomes. Binomial regression with robust error variance was used to evaluate whether group B streptococcus status modified the relationship between Foley balloon use and clinical chorioamnionitis and to adjust for confounders. RESULTS: A total of 491 patients were enrolled in the original trial. Of these patients, 467 had a known group B streptococcus status and underwent cervical ripening: 182 (39.0%) had group B streptococcus, and 285 (61.0%) did not have group B streptococcus. Moreover, 73.0% of patients received a Foley balloon, and 27.0% of patients did not receive a Foley balloon. There was no difference in the demographic or clinical characteristics between groups. The overall rate of clinical chorioamnionitis was 12.2%, with no difference between those with and without a Foley balloon (12.6% vs 11.1%, respectively; P=.66). Group B streptococcus status did not modify the association between Foley balloon use and clinical chorioamnionitis (relative risk, 0.93; 95% confidence interval, 0.50-1.72). This remained unchanged after adjusting for gestational age (adjusted relative risk, 0.87; 95% confidence interval, 0.45-1.67). Furthermore, other maternal and neonatal outcomes were similar between groups. CONCLUSION: In this secondary analysis of a large randomized trial using a standardized labor protocol, there was no increased risk of infectious morbidity with Foley balloon use in patients overall and in patients with group B streptococcus. Our findings support that a Foley balloon can be safely used for cervical ripening in patients with group B streptococcus colonization.

An innovative sequential mixed-methods approach to evaluating clinician acceptability during implementation of a standardized labor induction protocol.

BACKGROUND: Implementation outcomes, including acceptability, are of critical importance in both implementation research and practice. The gold standard measure of acceptability, Acceptability of Intervention Measure (AIM), skews positively with a limited range. In an ongoing hybrid effectiveness-implementation trial, we aimed to evaluate clinician acceptability of induction standardization. Here, we describe an innovative mixed-methods approach to maximize the interpretability of the AIM using a case study in maternal health. METHODS: In this explanatory sequential mixed methods study, we distributed the validated, 4-question AIM (total 4-20) to labor and delivery clinicians 6 months post-implementation at 2 sites (Site 1: 3/2021; Site 2: 6/2021). Respondents were grouped by total score into tertiles. The top ("High" Acceptability) and bottom ("Low" Acceptability) tertiles were invited to participate in a 30-minute semi-structured qualitative interview from 6/2021 to 10/2021 until thematic saturation was reached in each acceptability group. Participants were purposively sampled by role and site. Interviews were coded using an integrated approach, incorporating a priori attributes (Consolidated Framework for Implementation Research constructs) into a modified content analysis approach. RESULTS: 104 clinicians completed the initial survey; 24 were interviewed (12 "High" and 12 "Low" Acceptability). Median total AIM scores were 20/20 IQR[20-20] in the High and 12.5/20 IQR[11-14] in the Low Acceptability groups. In both groups, clinicians were enthusiastic about efforts to standardize labor induction, believing it reduces inter-clinician variability and improves equitable, evidence-based care. In the Low Acceptability group, clinicians stated the need for flexibility and consideration for patient uniqueness. Rarely, clinicians felt labor induction could not or should not be standardized, citing discomfort with medicalization of labor, and concerns with "bulldozing" the patient with interventions. Suggested strategies for overcoming negative sentiment included comprehensive clinician education, as well as involving patients as active participants in the protocol prenatally. CONCLUSIONS: This study utilized AIM in an innovative sequential mixed-methods approach to characterize clinician acceptability, which may be generalizable across implementation endeavors. By performing this work during a hybrid trial, implementation strategies to improve acceptability emerged (clinician education focusing on respect for flexibility; involving patients as active participants prenatally) for year 2, which will inform future multi-site work.

Efficacy of Propranolol to Reduce Cesarean Delivery in Prolonged Labor: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the rates of cesarean delivery in patients with prolonged labor randomized to receive intravenous (IV) propranolol compared with placebo. METHODS: A double-blind, placebo-controlled, randomized trial was conducted at two hospitals within a large academic health system. Eligible patients were at 36 weeks or more with a singleton gestation and prolonged labor , defined as: 1) prolonged latent phase of labor (dilation less than 6 cm after 8 hours or more with ruptured membranes and receiving oxytocin infusion) or 2) prolonged active phase of labor (dilation 6 cm or greater and less than 1-cm cervical dilation change over 2 hours or more with ruptured membranes and receiving oxytocin infusion). Patients were excluded for severe preeclampsia, maternal heart rate less than 70 beats per minute, maternal blood pressure less than 90/50 mm Hg, asthma, diabetes requiring insulin during labor, or a cardiac contraindication to ß-blockade. Patients were randomized to propranolol (2 mg IV) compared with placebo (2 mL normal saline IV), with one possible repeat dose. The primary outcome was cesarean delivery; secondary outcomes included labor duration, shoulder dystocia, and maternal and neonatal morbidity. With an estimated cesarean delivery rate of 45%, α 0.05, and 80% power, we required 163 patients per group to detect a 15% absolute reduction in cesarean delivery rate. A planned interim analysis was performed, and the trial was stopped for futility. RESULTS: From July 2020 to June 2022, 349 patients were eligible and approached; 164 were enrolled and randomized, with 84 in the propranolol group and 80 in the placebo group. The rate of cesarean delivery was not different between groups (57.1% propranolol vs 57.5% placebo, relative risk [RR] 0.99, 95% CI 0.76-1.29). Results were similar by subgroup of prolonged latent (n=123) and active (n=41) phases of labor and nulliparous (n=137) and multiparous (n=27) patients. Though not statistically significant, the frequency of postpartum hemorrhage was higher in the propranolol group (20% vs 10%, RR 2.02, 95% CI 0.93-4.43). CONCLUSION: In this multisite, double-blind, placebo-controlled randomized trial, there was no difference in cesarean delivery rate for patients who received propranolol compared with those who received placebo for management of prolonged labor. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04299438.

Genicular Artery Embolisation in Patients with Osteoarthritis of the Knee (GENESIS 2): Protocol for a Double-Blind Randomised Sham-Controlled Trial.

Knee osteoarthritis is a leading cause of chronic disability and economic burden. In many patients who are not surgical candidates, existing treatment options are insufficient. Clinical evidence for a new treatment approach, genicular artery embolisation (GAE), is currently limited to single arm cohort, or small population randomised studies. This trial will investigate the use of a permanent embolic agent for embolisation of abnormal genicular arterial vasculature to reduce pain in patients with mild to moderate knee osteoarthritis. Up to 110 participants, 45 years or older, with knee pain for ≥ 3 months resistant to conservative treatment will be randomised (1:1) to GAE or a sham procedure. The treatment group will receive embolisation using 100-micron Embozene™ microspheres (Varian, a Siemens Healthineers Company) (investigational use for this indication in the UK), and the sham group will receive 0.9% saline in an otherwise identical procedure. Patients will be followed for 24 months. At 6 months, sham participants will be offered crossover to GAE. The primary endpoint is change of 4 Knee Injury and OA Outcome Score subscales (KOOS4) at 6 months post-randomisation. The study will also evaluate quality of life, health economics, imaging findings, and psychosocial pain outcomes. The primary manuscript will be submitted for publication after all participants complete 6 months of follow-up. The trial is expected to run for 3.5 years. Trial Registration: ClinicalTrials.gov, Identifier: NCT05423587.

Association between intrapartum antibiotic prophylaxis for Group B Streptococcus colonization and clinical chorioamnionitis among patients undergoing induction of labor at term.

BACKGROUND: Rectovaginal colonization with Group B Streptococcus during pregnancy has historically been shown to be associated with an increased risk of clinical chorioamnionitis and peripartum infectious morbidity. OBJECTIVE: Newer observational data in the era of intrapartum antibiotic prophylaxis suggest a possible reversal of this association; however, it is unclear if this is related to differences in labor management for those with and without Group B Streptococcus colonization. We therefore sought to assess the association between intrapartum antibiotic prophylaxis for Group B Streptococcus colonization and clinical chorioamnionitis within the context of a randomized induction of labor trial with a standardized labor protocol. STUDY DESIGN: We performed an exploratory secondary analysis of a randomized trial of patients undergoing term induction at a tertiary care center. Patients received third trimester Group B Streptococcus screening and intrapartum antibiotic prophylaxis as routine care. Group B Streptococcus detection was performed using a carrot broth-enhanced subculture to Group B Streptococcus Detect approach (Hardy Diagnostics, Santa Maria, CA). Labor management was protocolized per the trial. Patients with unknown Group B Streptococcus status or who did not receive intrapartum antibiotic prophylaxis, if indicated, were excluded. The primary outcome was diagnosis of clinical chorioamnionitis, compared between patients who received intrapartum antibiotic prophylaxis for known Group B Streptococcus positive status (by culture, history, or Group B Streptococcus bacteriuria) and those who were Group B Streptococcus negative and did not receive intrapartum antibiotic prophylaxis. Secondary outcomes included postpartum endometritis, wound infection, a composite maternal peripartum infectious morbidity, and neonatal outcomes. RESULTS: A total of 491 patients were enrolled in the trial. Of these, 466 had a known Group B Streptococcus status and received or did not receive intrapartum antibiotic prophylaxis accordingly and were included in this analysis: 292 (62.7%) were Group B Streptococcus negative and did not receive intrapartum antibiotic prophylaxis, and 174 (37.3%) were Group B Streptococcus positive and received intrapartum antibiotic prophylaxis. The majority of patients were Non-Hispanic Black (78.1%) and nulliparous (59.7%). There were no differences in demographic, clinical, induction or labor characteristics between groups. Patients who were Group B Streptococcus positive had a 49% lower rate of clinical chorioamnionitis (8.1% vs 14.7%, odds ratio, 0.51; P=.03) and a lower rate of peripartum infectious morbidity (8.1% vs 15.8%, odds ratio, 0.47; P=.02) compared to those who were Group B Streptococcus negative. Infants born to patients who were Group B Streptococcus positive were significantly less likely to be admitted to the neonatal intensive care unit (3.4% vs 15.1%, P<.001). CONCLUSION: Although Group B Streptococcus colonization has historically been considered a risk factor for clinical chorioamnionitis, in the era of universal antibiotic prophylaxis for Group B Streptococcus positive patients, our findings support the point that intrapartum antibiotic prophylaxis for Group B Streptococcus positivity is associated with lower rates of clinical chorioamnionitis and peripartum infectious morbidity among patients undergoing induction with protocolized labor management. These findings demonstrate that intrapartum antibiotic prophylaxis for Group B Streptococcus may protect against perinatal infectious morbidity, a phenomenon that warrants further investigation.