Compromised SARS-CoV-2-specific placental antibody transfer.

SARS-CoV-2 infection causes more severe disease in pregnant women compared to age-matched non-pregnant women. Whether maternal infection causes changes in the transfer of immunity to infants remains unclear. Maternal infections have previously been associated with compromised placental antibody transfer, but the mechanism underlying this compromised transfer is not established. Here, we used systems serology to characterize the Fc profile of influenza-, pertussis-, and SARS-CoV-2-specific antibodies transferred across the placenta. Influenza- and pertussis-specific antibodies were actively transferred. However, SARS-CoV-2-specific antibody transfer was significantly reduced compared to influenza- and pertussis-specific antibodies, and cord titers and functional activity were lower than in maternal plasma. This effect was only observed in third-trimester infection. SARS-CoV-2-specific transfer was linked to altered SARS-CoV-2-antibody glycosylation profiles and was partially rescued by infection-induced increases in IgG and increased FCGR3A placental expression. These results point to unexpected compensatory mechanisms to boost immunity in neonates, providing insights for maternal vaccine design.

Performance of a Maternal Risk Stratification System for Predicting Low Apgar Scores.

OBJECTIVE: Maternal risk stratification systems are increasingly employed in predicting and preventing obstetric complications. These systems focus primarily on maternal morbidity, and few tools exist to stratify neonatal risk. We sought to determine if a maternal risk stratification score was associated with neonatal morbidity. STUDY DESIGN: Retrospective cohort study of patients with liveborn infants born at ≥24 weeks at four hospitals in one health system between January 1, 2020, and December 31, 2020. The Expanded Obstetric Comorbidity Score (EOCS) is used as the maternal risk score. The primary neonatal outcome was 5-minute Apgar <7. Logistic regression models determined associations between EOCS and neonatal morbidity. Secondary analyses were performed, including stratifying outcomes by gestational age and limiting analysis to "low-risk" term singletons. Model discrimination assessed using the area under the receiver operating characteristic curves (AUC) and calibration via calibration plots. RESULTS: A total of 14,497 maternal-neonatal pairs were included; 236 (1.6%) had 5-minute Apgar <7; EOCS was higher in 5-minute Apgar <7 group (median 41 vs. 11, p < 0.001). AUC for EOCS in predicting Apgar <7 was 0.72 (95% Confidence Interval (CI) 0.68, 0.75), demonstrating relatively good discrimination. Calibration plot revealed that those in the highest EOCS decile had higher risk of neonatal morbidity (7.6 vs. 1.7%, p < 0.001). When stratified by gestational age, discrimination weakened with advancing gestational age: AUC 0.70 for <28 weeks, 0.63 for 28 to 31 weeks, 0.64 for 32 to 36 weeks, and 0.61 for ≥37 weeks. When limited to term low-risk singletons, EOCS had lower discrimination for predicting neonatal morbidity and was not well calibrated. CONCLUSION: A maternal morbidity risk stratification system does not perform well in most patients giving birth, at low risk for neonatal complications. The findings suggest that the association between EOCS and 5-minute Apgar <7 likely reflects a relationship with prematurity. This study cautions against intentional or unintentional extrapolation of maternal morbidity risk for neonatal risk, especially for term deliveries. KEY POINTS: · EOCS had moderate discrimination for Apgar <7.. · Predictive performance declined when limited to low-risk term singletons.. · Relationship between EOCS and Apgar <7 was likely driven by prematurity..

Cost-effectiveness of induction of labor at 39 weeks vs expectant management by cervical examination.

BACKGROUND: Previous analyses have demonstrated the cost effectiveness of elective induction of labor at 39 weeks of gestation for healthy nulliparous people. However, elective induction of labor is resource intensive, and optimal resource allocation requires a thorough understanding of which subgroups of patients will benefit most. OBJECTIVE: This study aimed to determine whether induction of labor at 39 weeks of gestation is more cost-effective in patients with favorable or unfavorable cervical examinations. STUDY DESIGN: We constructed 2 decision analysis models using TreeAge software: one modeling induction of labor at 39 weeks of gestation vs expectant management for a group of nulliparous patients with unfavorable cervical examinations and the other modeling induction of labor at 39 weeks of gestation vs expectant management for a group with favorable cervical examinations. Estimates of cost, probability, and health state utility were derived from the literature. Based on previous literature, we assumed that people with favorable cervical examinations would have a lower baseline rate of cesarean delivery and higher rates of spontaneous labor. RESULTS: In our base case analysis, induction of labor at 39 weeks of gestation was cost-effective for patients with unfavorable cervical examinations, but not for patients with favorable cervical examinations. The incremental cost per quality-adjusted life year was 50-fold lower for people with unfavorable cervical examinations ($2150 vs $115,100). Induction of labor resulted in 3885 fewer cesarean deliveries and 58 fewer stillbirths per 100,000 patients for those with unfavorable examinations, whereas induction of labor resulted in 2293 fewer cesarean deliveries and 48 fewer stillbirths with labor induction for those with favorable cervical examinations. The results were sensitive to multiple inputs, including the likelihood of cesarean delivery, the cost of induction, the cost of vaginal or cesarean delivery, and the probability of spontaneous labor. In Monte Carlo analysis, the base case findings held true for 64.1% of modeled scenarios for patients with unfavorable cervixes and 55.4% of modeled scenarios for patients with favorable cervixes. CONCLUSION: With a willingness-to-pay threshold of $100,000 per quality-adjusted life year, induction of labor at 39 weeks of gestation may be cost-effective for patients with unfavorable cervical examinations, but not for patients with favorable cervical examinations. This result was driven by the likelihood of labor in patients with favorable cervical examinations, and the resultant avoidance of prolonged pregnancy and its complications, including hypertensive disorders of pregnancy and stillbirths. Health systems may wish to prioritize patients with unfavorable cervical examinations for elective induction of labor at 39 weeks of gestation, which may be opposite to common practice.

Change in Emergency Medical Services-Attended Out-of-Hospital Deliveries during COVID-19 in the United States.

BACKGROUND: The COVID-19 pandemic disrupted access to routine in-person prenatal care, potentially leading to higher risk of out-of-hospital deliveries. Unplanned out-of-hospital deliveries pose a substantial risk of morbidity and mortality for pregnant patients and newborns. Our objective was to determine the change in rate of emergency medical services (EMS)-attended out-of-hospital deliveries during the COVID-19 pandemic. We hypothesized that COVID-19-related stay-at-home orders were associated with a higher rate of out-of-hospital deliveries during the initial wave of COVID-19. METHODS: We conducted an interrupted time series analysis using the 2019 and 2020 National EMS Information System datasets. We included 9-1-1 scene activations for patients 12-50 years old with out-of-hospital deliveries who were treated and transported by EMS. We calculated the weekly rate of deliveries per 100,000 EMS emergency activations each year overall, and for each census division. The interruption modeled was the enactment of stay-at-home orders, with March 25-31 selected as when most orders had been enacted. We fit ordinary least squares regression models with Newey-West standard errors to adjust for autocorrelation, testing for a change in level and slope overall and by census division. RESULTS: A total of 10,778 out-of-hospital deliveries were included, 58% (n = 6,254) in 2020. The mean weekly rate of out-of-hospital deliveries in 2019 was 29.4 per 100,000 activations (95% CI: 28.4 to 30.4) versus 33.0 (95% CI: 31.8 to 34.1) in 2020. There was an immediate increase of 6.3 deliveries per 100,000 activations (95% CI: 3.3 to 9.3) after the week of March 25-31, with a subsequent decrease of 0.3 deliveries per 100,000 per week after (95% CI: -0.4 to -0.2). There were also statistically significant immediate increases in out-of-hospital deliveries after March 25-31 in the New England, East North Central, West South Central, and Mountain divisions. CONCLUSION: EMS-attended out-of-hospital deliveries remained rare during the COVID-19 pandemic, but there was an immediate increase during the initial wave of the pandemic with evidence of geographic variation. Large-scale disruptions in the health care system may result in increases in uncommon patient presentations to EMS.

Epidemiology of Emergency Medical Services-Attended out-of-Hospital Deliveries and Complications in the United States.

BACKGROUND: Prehospital obstetric events, including out-of-hospital deliveries and their complications, are a rare but high-risk event encountered by emergency medical services (EMS). Understanding the epidemiology of these encounters would help identify strategies to improve prehospital obstetric care. Our objective was to determine the characteristics of out-of-hospital deliveries and high-risk complications treated by EMS clinicians in the U.S. METHODS: We conducted a cross-sectional analysis of EMS patient care records in the 2018 and 2019 National EMS Information System Public Release Version 3.4 datasets. We included EMS activations after a 9-1-1 scene response for patients aged 12-50 years with evidence of an out-of-hospital delivery or delivery complication, or where the patient was a newborn aged 0-<6 h. We examined patient, community, emergency response, and clinical characteristics using descriptive statistics. RESULTS: Of the 56,735,977 EMS activations included in the 2018 and 2019 datasets, there were 8,614 out-of-hospital deliveries, 1,712 delivery complications, and 5,749 records for newborns. Most maternal (76%) out-of-hospital deliveries involved patients between the ages of 20-34 years, occurred on a weekday (73%), were treated by an advanced life support crew (85%), and occurred in a home or residence (73%). EMS-assisted field delivery was documented in 3,515 (34%) of all maternal activations but only 2% of activations with a delivery complication. Few patients received an EMS-administered medication (e.g., 0.4% received oxytocin). Supplemental oxygen was administered in 870 (15%) of newborn activations. Activations from counties with the most racial/ethnic diversity were more often treated by a BLS-level unit (16% vs. 12%, p < 0.001), and activations from rural areas had significantly longer transport times (19.7 min [IQR 8.7, 32.8] vs. urban, 13.1 min [IQR 8.7, 19.7], p < 0.001). CONCLUSION: In this large, national repository of EMS patient care records from across the U.S., most activations for out-of-hospital delivery, delivery complication, or a newborn included only routine EMS care. There were potential disparities in level of care, clinical care provided, and measures of access to definitive care based on maternal and community factors. We also identified gaps in current practice, such as for postpartum hemorrhage, that could be addressed with changes in EMS clinical protocols and regulations.

Comparison of Maternal and Neonatal Subspecialty Care Provision by Hospital.

OBJECTIVE: The aim of the study is to determine the relationship between a hospital's provision of subspecialty neonatal and maternal care. Specifically, we sought to understand where women with high-risk maternal conditions received intrapartum care and estimate the potential transfer burden for those with maternal high-risk conditions delivering at hospitals without subspecialty maternal care. STUDY DESIGN: This is a descriptive study using data from 2015 State Inpatient Databases and the American Hospital Association Annual Survey. Characteristics were compared between hospitals based on the concordance of their maternal and neonatal care. The incidences of high-risk maternal conditions (pre-eclampsia with severe features, placenta previa with prior cesarean delivery, cardiac disease, pulmonary edema, and acute liver failure) were compared. To determine the potential referral burden, the percent of women with high-risk conditions delivering at a hospital without subspecialty maternal care but delivering in a county with a hospital with subspecialty maternal care was calculated. RESULTS: The analysis included 486,398 women who delivered at 544 hospitals, of which 104 (19%) and 182 (33%) had subspecialty maternal and neonatal care, respectively. Ninety-eight hospitals provided both subspecialty maternal and neonatal care; however, 84 hospitals provided only subspecialty neonatal care but no subspecialty maternal care. Among high-risk maternal conditions examined, approximately 65% of women delivered at a hospital with subspecialty maternal care. Of the remainder who delivered at a hospital without subspecialty maternal care, one-third were in a county where subspecialty care was present. For women with high-risk conditions who delivered in a county without subspecialty maternal care, the median distance to the closest county with subspecialty care was 52.8 miles (IQR: 34.3-87.7 miles). CONCLUSION: Approximately 50% of hospitals with subspecialty neonatal care do not provide subspecialty maternal care. This discordance may present a challenge when both high-risk maternal and neonatal conditions are present. KEY POINTS: · High-risk women who deliver at hospitals without subspecialty care are in more rural areas.. · Approximately 50% of hospitals with subspecialty neonatal care do not provide subspecialty maternal care.. · This discordance may present a challenge when both high-risk maternal and neonatal conditions are present..

The Application of a Standard Risk Threshold for the Stratification of Maternal Morbidity among Population Subgroups.

OBJECTIVE: The aim of this study was to determine if a universally applied risk score threshold for severe maternal morbidity (SMM) resulted in different performance characteristics among subgroups of the population. STUDY DESIGN: This is a retrospective cohort study of deliveries that occurred between July 1, 2016, and June 30, 2020, in a single health system. We examined the performance of a validated comorbidity score to stratify SMM risk in our cohort. We considered the risk score that was associated with the highest decile of predicted risk as a "screen positive" for morbidity. We then used this same threshold to calculate the sensitivity and positive predictive value (PPV) of this "highest risk" designation among subgroups of the overall cohort based on the following characteristics: age, race/ethnicity, parity, gestational age, and planned mode of delivery. RESULTS: In the overall cohort of 53,982 women, the C-statistic was 0.755 (95% confidence interval [CI], 0.741-0.769) and calibration plot demonstrated that the risk score was well calibrated. The model performed less well in the following groups: non-White or Hispanic (C-statistic, 0.734; 95% CI, 0.712-0.755), nulliparas (C-statistic, 0.735; 95% CI, 0.716-0.754), term deliveries (C-statistic, 0.712; 95% CI, 0.694-0.729), and planned vaginal delivery (C-statistic, 0.728; 95% CI, 0.709-0.747). There were differences in the PPVs by gestational age (7.8% term and 29.7% preterm) and by planned mode of delivery (8.7% vaginal and 17.7% cesarean delivery). Sensitivities were lower in women who were <35 years (36.6%), non-White or Hispanic (40.7%), nulliparous (38.9%), and those having a planned vaginal delivery (40.9%) than their counterparts. CONCLUSION: The performance of a risk score for SMM can vary by population subgroups when using standard thresholds derived from the overall cohort. If applied without such considerations, such thresholds may be less likely to identify certain subgroups of the population that may be at increased risk of SMM. KEY POINTS: · Predictive risk models are helpful at condensing complex information into an interpretable output.. · Model performance may vary among different population subgroups.. · Prediction models should be examined for their potential to exacerbate underlying disparities..

Natural language processing of admission notes to predict severe maternal morbidity during the delivery encounter.

BACKGROUND: Severe maternal morbidity and mortality remain public health priorities in the United States, given their high rates relative to other high-income countries and the notable racial and ethnic disparities that exist. In general, accurate risk stratification methods are needed to help patients, providers, hospitals, and health systems plan for and potentially avert adverse outcomes. OBJECTIVE: Our objective was to understand if machine learning methods with natural language processing of history and physical notes could identify a group of patients at high risk of maternal morbidity on admission for delivery without relying on any additional patient information (eg, demographics and diagnosis codes). STUDY DESIGN: This was a retrospective study of people admitted for delivery at 2 hospitals (hospitals A and B) in a single healthcare system between July 1, 2016, and June 30, 2020. The primary outcome was severe maternal morbidity, as defined by the Centers for Disease Control and Prevention; furthermore, we examined nontransfusion severe maternal morbidity. Clinician documents designated as history and physical notes were extracted from the electronic health record for processing and analysis. A bag-of-words approach was used for this natural language processing analysis (ie, each history or physical note was converted into a matrix of counts of individual words (or phrases) that occurred within the document). The least absolute shrinkage and selection operator models were used to generate prediction probabilities for severe maternal morbidity and nontransfusion severe maternal morbidity for each note. Model discrimination was assessed via the area under the receiver operating curve. Discrimination was compared between models using the DeLong test. Calibration plots were generated to assess model calibration. Moreover, the natural language processing models with history and physical note texts were compared with validated obstetrical comorbidity risk scores based on diagnosis codes. RESULTS: There were 13,572 delivery encounters with history and physical notes from hospital A, split between training (Atrain, n=10,250) and testing (Atest, n=3,322) datasets for model derivation and internal validation. There were 23,397 delivery encounters with history and physical notes from hospital B (Bvalid) used for external validation. For the outcome of severe maternal morbidity, the natural language processing model had an area under the receiver operating curve of 0.67 (95% confidence interval, 0.63-0.72) and 0.72 (95% confidence interval, 0.70-0.74) in the Atest and Bvalid datasets, respectively. For the outcome of nontransfusion severe maternal morbidity, the area under the receiver operating curve was 0.72 (95% confidence interval, 0.65-0.80) and 0.76 (95% confidence interval, 0.73-0.79) in the Atest and Bvalid datasets, respectively. The calibration plots demonstrated the bag-of-words model's ability to distinguish a group of individuals at a substantially higher risk of severe maternal morbidity and nontransfusion severe maternal morbidity, notably those in the top deciles of predicted risk. Areas under the receiver operating curve in the natural language processing-based models were similar to those generated using a validated, retrospectively derived, diagnosis code-based comorbidity score. CONCLUSION: In this practical application of machine learning, we demonstrated the capabilities of natural language processing for the prediction of severe maternal morbidity based on provider documentation inherently generated at the time of admission. This work should serve as a catalyst for providers, hospitals, and electronic health record systems to explore ways that artificial intelligence can be incorporated into clinical practice and evaluated rigorously for their ability to improve health.

Prolonged Second Stage of Labor and Anal Sphincter Injury in a Contemporary Cohort of Term Nulliparas.

OBJECTIVE: This study aimed to assess whether a prolonged second stage of labor is an independent predictor of obstetric anal sphincter injury (OASI) in a contemporary cohort of nulliparous and term parturients, and to evaluate whether predelivery factors can accurately predict OASI. STUDY DESIGN: This was a nested case-control study within a cohort of consecutive nulliparous term parturients with a singleton gestation who underwent a vaginal delivery at a single institution between January 2014 and January 2015. Cases were defined as women with a third- or fourth-degree laceration at the time of delivery, and controls were women without a third- or fourth-degree laceration. A prolonged second stage was defined as a second stage of ≥3 hours. Univariable and multivariable regression analyses were performed to examine the relationship between prolonged second stage of labor and third- or fourth-degree lacerations. Receiver operator curves were developed to assess the predictive capacity of predelivery information for third- and fourth-degree lacerations. RESULTS: Of 1,197 births, 63 women had third- or fourth-degree lacerations (5.3%). With each additional hour of the second stage, the rate of OASI increased, with 2.9% of women with a second stage of <1 hour with OASI, 3.5% between 1 and 2 hours, 5.7% between 2 and 3 hours, 7.8% between 3 and 4 hours, 16.1% between 4 and 5 hours, and 28.6% among women with a second stage length >5 hours (p < 0.001). In multivariable regression analysis, operative vaginal delivery (adjusted odds ratio [aOR] = 5.92, 95% confidence interval [CI]: 3.17-11.07) and a prolonged second stage (aOR = 1.92, 95% CI: 1.06-3.51) were independent predictors of third- and fourth-degree lacerations. A predictive model was developed from these results (area under the curve [AUC] = 0.75, 95% CI: 0.68-0.81). CONCLUSION: Prolonged second stage of labor is a predictor of OASI, after adjustment for operative vaginal delivery. A model using predelivery risk factors has a reasonable prediction of OASI. KEY POINTS: · Prolonged second stage labor is associated with obstetric anal sphincter injury in term nulliparas.. · Predelivery risk factors reasonably predict obstetric anal sphincter injury in term nulliparas.. · Improved models are needed for clinical risk-stratification..

Placental Expression of ACE2 and TMPRSS2 in Maternal Severe Acute Respiratory Syndrome Coronavirus 2 Infection: Are Placental Defenses Mediated by Fetal Sex?

BACKGROUND: Expression of angiotensin-converting enzyme 2 (ACE2) and type II transmembrane serine protease (TMPRSS2), host molecules required for viral entry, may underlie sex differences in vulnerability to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We investigated whether placental ACE2 and TMPRSS2 expression vary by fetal sex in the presence of maternal SARS-CoV-2 infection. METHODS: Placental ACE2 and TMPRSS2 expression was quantified by quantitative reverse transcription polymerase chain reaction (RT-PCR) and by Western blot in 68 pregnant women (38 SARS-CoV-2 positive, 30 SARS-CoV-2 negative) delivering at Mass General Brigham from April to June 2020. The impact of fetal sex and maternal SARS-CoV-2 exposure on ACE2 and TMPRSS2 was analyzed by 2-way analysis of variance (ANOVA). RESULTS: Maternal SARS-CoV-2 infection impacted placental TMPRSS2 expression in a sexually dimorphic fashion (2-way ANOVA interaction, P = .002). We observed no impact of fetal sex or maternal SARS-CoV-2 status on ACE2. TMPRSS2 expression was significantly correlated with ACE2 expression in males (Spearman ρ = 0.54, P = .02) but not females (ρ = 0.23, P = .34) exposed to maternal SARS-CoV-2. CONCLUSIONS: Sex differences in placental TMPRSS2 but not ACE2 were observed in the setting of maternal SARS-CoV-2 infection, which may have implications for offspring vulnerability to placental infection.

Postpartum depression screening: Treatment engagement, barriers to care, and change in depressive symptoms.

BACKGROUND: Postpartum depression (PPD) is a common condition associated with childbirth, yet many women do not receive the treatment they need. Despite the growing practice of PPD screening, treatment and clinical outcomes among patients identified as likely having PPD remain unclear. METHOD: Women who were systematically screened and scored ≥12 on the Edinburgh Postnatal Depression Scale (EPDS)-indicative of possible PPD-at their routine 6-week postpartum visit were eligible to participate and were contacted after 3 months for a follow-up interview and assessment. RESULTS: A total of 33 women participated in the study, out of 100 who scored ≥12 on the EPDS. Among the participants, 70% reported they received a referral to a health care provider for PPD, and nearly one-half said that they received psychotherapy and/or were prescribed a psychotropic. The 2 most commonly described barriers to treatment were perceptions of not needing or wanting help and concerns about breastfeeding while taking psychotropics. Nearly 40% of women scored ≥12 on the EPDS at the follow-up interview. CONCLUSIONS: Further systematic research on outcomes after PPD screening is needed to ensure that screening translates into meaningfully improved clinical outcomes.

Frequency and severity of prehospital obstetric events encountered by emergency medical services in the United States.

BACKGROUND: Prehospital obstetric events encountered by emergency medical services (EMS) can be high-risk patient presentations for which suboptimal care can cause substantial morbidity and mortality. The frequency of prehospital obstetric events is unclear because existing descriptions have reported obstetric and gynecological conditions together, without delineating specific patient presentations. Our objective was to identify the types, frequency, and acuity of prehospital obstetric events treated by EMS personnel in the US. METHODS: We conducted a cross-sectional analysis of EMS patient care records in the 2018 National EMS Information System dataset (n=22,532,890). We focused on EMS activations (i.e., calls for service) for an emergency scene response for patients aged 12-50 years with evidence of an obstetric event. Type of obstetric event was determined by examining patient symptoms, the treating EMS provider's impression (i.e., field diagnosis), and procedures performed. High patient acuity was ascertained by EMS documentation of patient status and application of the modified early obstetric warning system (MEOWS) criteria, with concordance assessed using Cohen's kappa. Descriptive statistics were calculated to describe the primary symptoms, impressions, and frequency of each type of obstetric event among these activations. RESULTS: A total of 107,771 (0.6%) of EMS emergency activations were identified as involving an obstetric event. The most common presentation was early or threatened labor (15%). Abdominal complaints, including pain and other digestive/abdomen signs and symptoms, was the most common primary symptom (29%) and primary impression (18%). We identified 3,489 (3%) out-of-hospital deliveries, of which 1,504 were preterm. Overall, EMS providers documented 34% of patients as being high acuity, similar to the MEOWS criteria (35%); however, there were high rates of missing data for EMS documented acuity (19%), poor concordance between the two measures (Cohen's kappa=0.12), and acuity differences for specific conditions (e.g., high acuity of non-cephalic presentations, 77% in EMS documentation versus 53% identified by MEOWS). CONCLUSION: Prehospital obstetric events were infrequently encountered by EMS personnel, and about one-third were high acuity. Additional work to understand the epidemiology and clinical care of these patients by EMS would help to optimize prehospital care and outcomes.

Association of sexual assault history with traumatic childbirth and subsequent PTSD.

Although childbirth-related posttraumatic stress (CB-PTSD) has received recognition, how sexual assault (SA) history influences obstetrical and traumatic stress outcomes remains unclear. Six hundred eighty-three women provided information about their childbirth and mental health. Obstetric complications and unplanned cesareans were more prevalent among women with SA history. They also had higher rates of probable CB-PTSD and were two times more likely to have premature deliveries than women without SA history. Screening women for history of sexual trauma is warranted to optimize birth outcomes.

Oxytocin Compared to Buccal Misoprostol for Induction of Labor after Term Prelabor Rupture of Membranes.

OBJECTIVE: This study was aimed to determine if admission-to-delivery times vary between term nulliparous women with prelabor rupture of membranes (PROM) who initially receive oxytocin compared with buccal misoprostol for labor induction. STUDY DESIGN: This is a retrospective cohort of 130 term, nulliparous women with PROM and cervical dilation of ≤2 cm who underwent induction of labor with intravenous oxytocin or buccal misoprostol. The primary outcome was time from admission to delivery. Linear regressions with log transformation were used to estimate the effect of induction agent on time to delivery. RESULTS: Women receiving oxytocin had faster admission-to-delivery times than women receiving misoprostol (16.9 vs. 19.9 hours, p = 0.013). There were no significant differences in secondary outcomes between the groups. In the adjusted model, women who received misoprostol had a 22% longer time from admission to delivery (95% CI 5.0-42.0%) compared with women receiving oxytocin. CONCLUSION: In term nulliparous patients with PROM, intravenous oxytocin is associated with faster admission-to-delivery times than buccal misoprostol.

Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled.

BACKGROUND: Collection of biospecimens is a critical first step to understanding the impact of COVID-19 on pregnant women and newborns - vulnerable populations that are challenging to enroll and at risk of exclusion from research. We describe the establishment of a COVID-19 perinatal biorepository, the unique challenges imposed by the COVID-19 pandemic, and strategies used to overcome them. METHODS: A transdisciplinary approach was developed to maximize the enrollment of pregnant women and their newborns into a COVID-19 prospective cohort and tissue biorepository, established on March 19, 2020 at Massachusetts General Hospital (MGH). The first SARS-CoV-2 positive pregnant woman was enrolled on April 2, and enrollment was expanded to SARS-CoV-2 negative controls on April 20. A unified enrollment strategy with a single consent process for pregnant women and newborns was implemented on May 4. SARS-CoV-2 status was determined by viral detection on RT-PCR of a nasopharyngeal swab. Wide-ranging and pregnancy-specific samples were collected from maternal participants during pregnancy and postpartum. Newborn samples were collected during the initial hospitalization. RESULTS: Between April 2 and June 9, 100 women and 78 newborns were enrolled in the MGH COVID-19 biorepository. The rate of dyad enrollment and number of samples collected per woman significantly increased after changes to enrollment strategy (from 5 to over 8 dyads/week, P < 0.0001, and from 7 to 9 samples, P < 0.01). The number of samples collected per woman was higher in SARS-CoV-2 negative than positive women (9 vs 7 samples, P = 0.0007). The highest sample yield was for placenta (96%), umbilical cord blood (93%), urine (99%), and maternal blood (91%). The lowest-yield sample types were maternal stool (30%) and breastmilk (22%). Of the 61 delivered women who also enrolled their newborns, fewer women agreed to neonatal blood compared to cord blood (39 vs 58, P < 0.0001). CONCLUSIONS: Establishing a COVID-19 perinatal biorepository required patient advocacy, transdisciplinary collaboration and creative solutions to unique challenges. This biorepository is unique in its comprehensive sample collection and the inclusion of a control population. It serves as an important resource for research into the impact of COVID-19 on pregnant women and newborns and provides lessons for future biorepository efforts.

Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.

Importance: Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates. Objective: To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality. Design, Setting, and Participants: Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019. Interventions: Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743). Main Outcomes and Measures: The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality. Results: Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important). Conclusions and Relevance: Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.

Unexpected term NICU admissions: a marker of obstetrical care quality?

BACKGROUND: Unexpected admissions of term neonates to the neonatal intensive care unit and unexpected postnatal complications have been proposed as neonatal-focused quality metrics for intrapartum care. Previous studies have noted significant variation in overall hospital neonatal intensive care unit admission rates; however, little is known about the influence of obstetric practices on these rates or whether variation among unanticipated admissions in low-risk, term neonates can be attributed to systemic hospital practices. OBJECTIVE: The objective of the study was to examine the relative effects of patient characteristics and intrapartum events on unexpected neonatal intensive care unit admissions and to quantify the between-hospital variation in neonatal intensive care unit admission rates among this group of neonates. STUDY DESIGN: We performed a retrospective cross-sectional study using data collected as part of the Consortium for Safe Labor study. Women who delivered term (≥37 weeks), singleton, nonanomalous, liveborn infants without an a priori risk for neonatal intensive care unit admission were included. The primary outcome was neonatal intensive care unit admission among this population. Multilevel mixed-effect models were used to calculate adjusted odds ratios for demographics (age, race, insurer), pregnancy characteristics (parity, gestational age, tobacco use, birthweight), maternal comorbidities (chronic and pregnancy-induced hypertension), hospital characteristics (delivery volume, hospital and neonatal intensive care unit level, academic affiliation), and intrapartum events (prolonged second stage, induction of labor, trial of labor after cesarean delivery, chorioamnionitis, meconium-stained amniotic fluid, and abruption). Intraclass correlation coefficients were used to estimate the between-hospital variance in a series of hierarchical models. RESULTS: Of the 143,951 infants meeting all patient and hospital inclusion criteria, 7995 (5.6%) were admitted to the neonatal intensive care unit after birth. In the fully adjusted model, the factors associated with the highest odds for neonatal intensive care unit admission included: nulliparity (adjusted odds ratio, 1.62 [95% confidence interval, 1.53-1.71]), large for gestational age (adjusted odds ratio, 1.59 [95% confidence interval, 1.47-1.71]), and small for gestational age (adjusted odds ratio, 1.60 [95% confidence interval, 1.47-1.73]). Induction of labor (adjusted odds ratio, 0.95 [95% confidence interval, 0.89-1.01]) was not associated with increased odds of neonatal intensive care unit admission compared with women who labored spontaneously. The events associated with higher odds of neonatal intensive care unit admission included: prolonged second stage (adjusted odds ratio, 1.66 [95% confidence interval, 1.51-1.83]); chorioamnionitis (adjusted odds ratio, 3.89 [95% confidence interval, 3.42-4.44]), meconium-stained amniotic fluid (adjusted odds ratio, 1.96 [95% confidence interval, 1.82-2.10]), and abruption (adjusted odds ratio, 2.64 [95% confidence interval, 2.16-.21]). Compared with women who did not labor, the odds of neonatal intensive care unit admission were lower for women who labored: adjusted odds ratio, 0.48 (95% confidence interval, 0.45-0.52) for women with no uterine scar and adjusted odds ratio, 0.83 (95% confidence interval, 0.73-0.94) for women with a uterine scar. There was significant variation in neonatal intensive care unit admission rates by hospital, ranging from 2.9% to 11.2%. After accounting for case mix and hospital characteristics, the between-hospital variance was 1.9%, suggesting that little of the variation was explained by the effect of the hospital. CONCLUSION: This study contributes to the currently limited understanding of term, neonatal intensive care unit admission rates as a marker of obstetrical care quality. We demonstrated that significant variation exists in hospital unexpected neonatal intensive care unit admission rates and that certain intrapartum events are associated with an increased risk for neonatal intensive care unit admission after delivery. However, the between-hospital variation was low. Unmeasured confounders and extrinsic factors, such as neonatal intensive care unit bed availability, may limit the ability of unexpected term neonatal intensive care unit admissions to meaningfully reflect obstetrical care quality.

Hospital bans on trial of labor after cesarean and antepartum transfer of care.

BACKGROUND: Hospital policies restricting access to trial of labor after cesarean (TOLAC) are prevalent. Many women with a previous cesarean birth are affected by these bans, but there are limited data on the effect of these bans and whether women would consider changing delivery hospitals in the setting of a real or hypothetical TOLAC ban. METHODS: This was a survey of TOLAC-eligible women receiving prenatal care at four hospitals where TOLAC is available, and 1 non-TOLAC site. Participants were asked about their likelihood of switching hospitals to pursue TOLAC if it were unavailable. Women at the non-TOLAC site had their medical records reviewed to ascertain final location and approach to delivery. RESULTS: A total of 297 women were interviewed, 48 from the non-TOLAC site. 162 (54%) participants indicated they would transfer care if TOLAC were unavailable. Among women at the non-TOLAC site, 57% who indicated an intention to switch hospitals did so. In a multivariable logistic regression model, variables associated with transferring care included race/ethnicity other than Latina (aOR 25.20 [95% CI 2.23-284.26]), being unaware of the TOLAC ban (19.81 [1.99-196.64]), and perceiving that a close friend/relative thought they should undergo TOLAC (17.31 [1.70-176.06]). CONCLUSIONS: More than half of women with prior cesarean would consider transferring care if TOLAC became unavailable, and more than 1 of 3 of women at a non-TOLAC site transferred care. More research is needed on the impact of TOLAC bans and how to facilitate transfer for those who desire TOLAC.

Using Cervical Dilation to Predict Labor Onset: A Tool for Elective Labor Induction Counseling.

OBJECTIVE: To evaluate whether cervical dilation predicts the timing and likelihood of spontaneous labor at term. STUDY DESIGN: This was a retrospective cohort of nulliparous women with singleton pregnancies who delivered at term from 2013 to 2015. Outpatient cervical examinations performed after 37 weeks and prior to labor onset were collected. Survival analysis was used to analyze time to spontaneous labor with cervical dilation as the primary predictor, modeled as continuous and categorical variables (<1 cm, 1 cm, >1 cm). RESULTS: Our cohort included 726 women; 407 (56%) spontaneously labored, 263 (36%) were induced, and 56 (8%) had an unlabored cesarean delivery. Women with >1-cm dilation were three times more likely to spontaneously labor (adjusted hazard ratio [aHR]: 3.1; 95% confidence interval [CI]: 2.4-4) than those with <1-cm dilation. At 39 weeks, 60% of women with >1-cm dilation went into spontaneous labor as compared with only 28% of those with <1-cm dilation (aHR: 2.9; 95% CI: 2-4.4). CONCLUSION: In our cohort of nulliparous women at term, those with cervical dilation > 1 cm were significantly more likely to go into labor in the following week. This information can aid in counseling about elective induction of labor.

Heard but Excluded: A Language Manifesto.

This Viewpoint discusses dismantling language barriers via multipronged approaches grounded in innovation, human-centered design, and systems thinking in 3 key areas.