Characteristics of women concordant and discordant for urine drug screens for cannabis exposure and self-reported cannabis use during pregnancy.

BACKGROUND: Increasing cannabis use among pregnant people and equivocal evidence linking prenatal cannabis exposure to adverse outcomes in offspring highlights the need to understand its potential impact on pregnancy and child outcomes. Assessing cannabis use during pregnancy remains a major challenge with potential influences of stigma on self-report as well as detection limitations of easily collected biological matrices. OBJECTIVE: This descriptive study examined the concordance between self-reported (SR) cannabis use and urine drug screen (UDS) detection of cannabis exposure during the first trimester of pregnancy and characterized concordant and discordant groups for sociodemographic factors, modes of use, secondhand exposure to cannabis and tobacco, and alcohol use and cotinine positivity. STUDY DESIGN: The Cannabis Use During Development and Early Life (CUDDEL) Study is an ongoing longitudinal study that recruits pregnant individuals presenting for obstetric care, who report lifetime cannabis use as well as using (n = 289) or not using cannabis (n = 169) during pregnancy. During the first trimester pregnancy visit, SR of cannabis use and a UDS for cannabis, other illicit drugs and nicotine are acquired from eligible participants, of whom 333 as of 05/01/2023 had both. RESULTS: Using available CUDDEL Study data on both SR and UDS (n = 333; age 26.6 ± 4.7; 88.6% Black; 45.4% below federal poverty threshold; 56.5% with paid employment; 89% with high school education; 22% first pregnancy; 12.3 ± 3.6 weeks gestation), we classified pregnant individuals with SR and UDS data into 4 groups based on concordance (k = 0.49 [95% C.I. 0.40-0.58]) between SR cannabis use and UDS cannabis detection during the first trimester: 1) SR+/UDS+ (n = 107); 2) SR-/UDS- (n = 142); 3) SR+/UDS- (n = 44); 4) SR-/UDS+ (n = 40). Those who were SR+/UDS- reported less frequent cannabis use and fewer hours under the influence of cannabis during their pregnancy. Those who were SR-/UDS+ were more likely to have joined the study at a lower gestational age with 62.5% reporting cannabis use during their pregnancy prior to being aware that they were pregnant. Of the 40 SR-/UDS+ women, 14 (i.e., 35%) reported past month secondhand exposure, or blunt usage. In the subset of individuals with SR and UDS available at trimester 2 (N = 160) and 3 (N = 140), concordant groups were mostly stable and > 50% of those in the discordant groups became concordant by the second trimester. Classifying individuals as exposed or not exposed who were SR+ and/or UDS+ resulted in minor changes in group status based on self-report at screening. CONCLUSION: Overall, there was moderate concordance between SR and UDS for cannabis use/exposure during pregnancy. Instances of SR+/UDS- discordancy may partially be attributable to lower levels of use that are not detected on UDS. SR-/UDS+ discordancy may arise from recent use prior to knowledge of pregnancy, extreme secondhand exposure, deception, and challenges with completing questionnaires. Acquiring both self-report and biological detection of cannabis use/exposure allows for the examination of convergent evidence. Classifying those who are SR+ and/or UDS+ as individuals who used cannabis during their first trimester after being aware of their pregnancy resulted in only a minor change in exposure status; thus, relying on self-report screening, at least in this population and within this sociocultural context likely provides an adequate approximation of cannabis use during pregnancy.

Dietary risk factors for hypertensive disorders of pregnancy.

OBJECTIVE: To assess whether diet quality and specific dietary components are associated with hypertensive disorders of pregnancy (HDP). STUDY DESIGN: Nested case control study in a prospectively collected cohort of 450 participants with singleton pregnancies who completed the National Institutes of Health Diet Health Questionnaire II (DHQ-II) in the third trimester or within 3 months of delivery. Patients with fetal anomalies, conception by in-vitro fertilization, and deliveries at outside hospitals were excluded from the original prospective cohort study. Cases were patients diagnosed with HDP and controls were patients without HDP. Cases and controls were matched by BMI class in a 1:2 ratio. Exposures of interest were HEI-2015 score components and other DHQ-II dietary components including minerals, caffeine, and water. These dietary components were compared between cohorts using univariate analyses. MAIN OUTCOME MEASURES: HEI-2015 total scores representing diet quality, component scores, and objective background data between patients with HDP and patients without HDP. RESULTS: 150 patients with HDP were matched to 300 controls without HDP. Baseline demographics were similar between groups, including BMI. Patients with HDP were less likely to have high quality diets (HEI ≥ 70) than controls (7.3 % v 15.7 %, P = 0.02). HDP were associated with significantly higher dairy, saturated fat, and sodium intake compared to controls. Other components were similar between groups. CONCLUSION: Patients with HDP are more likely to have lower diet quality and higher consumption of sodium, dairy, and saturated fats. These results can be used to study antenatal diet modification in patients at high risk of HDP.

County-level neonatal opioid withdrawal syndrome rates and real-world access to buprenorphine during pregnancy: An audit ("secret shopper") study in Missouri.

Background: Amid rising rates of neonatal opioid withdrawal syndrome (NOWS) worldwide and in many regions of the USA, we conducted an audit study ("secret shopper study") to evaluate the influence of county-level buprenorphine capacity and rurality on county-level NOWS rates. Methods: In 2019, up to three phone calls were made to buprenorphine prescribers in the state of Missouri (USA). County-level buprenorphine capacity was defined as the number of clinicians (across all specialties) accepting pregnant people divided by the number of births. Multivariable negative binomial regression models estimated associations between buprenorphine capacity, rurality, and county-level NOWS rates, controlling for potential confounders (i.e., poverty, unemployment, and physician shortages) that may correspond to higher rates of NOWS and lower rates of buprenorphine prescribing. Analyses were stratified using tertiles of county-level overdose rates (top, middle, and lowest 1/3 of overdose rates). Results: Of 115 Missouri counties, 81(70 %) had no buprenorphine capacity, 17(15 %) were low-capacity (<0.5-clinicians/1,000 births), and 17(15 %) were high-capacity (≥0.5/1,000 births). The mean NOWS rate was 6.5/1,000 births. In Missouri counties with both the highest and lowest opioid overdose rates, higher buprenorphine capacity did not correspond to decreases in NOWS rates (incidence rate ratio[IRR]=1.23[95 %-confidence-interval[CI]=0.65-2.32] and IRR=1.57[1.21-2.03] respectively). Rurality did not correspond to greater NOWS burden in both Missouri counties with highest and lowest opioid overdose rates. Conclusions: The vast majority of counties in Missouri have no capacity for buprenorphine prescribing during pregnancy. Rurality and lower buprenorphine capacity did not significantly predict elevated rates of NOWS.

Elevating Voices, Addressing Depression, Toxic Stress, and Equity Through Group Prenatal Care: A Pilot Study.

Introduction: Elevating Voices, Addressing Depression, Toxic Stress and Equity (EleVATE) is a group prenatal care (GC) model designed to improve pregnancy outcomes and promote health equity for Black birthing people. This article outlines the foundational community-engaged process to develop EleVATE GC and pilot study results. Methods: We used community-based participatory research principles and the Ferguson Commission Report to guide creation of EleVATE GC. The intervention, designed by and for Black birthing people, centers trauma-informed care, antiracism, and integrates behavioral health strategies into group prenatal care to address unmet mental health needs. Using a convenience sample of patients seeking care at one of three safety-net health care sites, we compared preterm birth, small for gestational age, depression scores, and other pregnancy outcomes between patients in individual care (IC), CenteringPregnancy™ (CP), and EleVATE GC. Results: Forty-eight patients enrolled in the study (n=11 IC; n=14 CP; n=23 EleVATE GC) and 86% self-identified as Black. Patients participating in group prenatal care (EleVATE GC or CP) were significantly less likely to experience a preterm birth <34 weeks. Rates of small for gestational age, preterm birth <37 weeks, depression scores, and other pregnancy outcomes were similar across groups. Participants in CP and EleVATE GC were more likely to attend their postpartum visit and breastfeed at hospital discharge than those in IC. Discussion: Our findings model a systematic approach to design a feasible, patient-centered, community-based, trauma-informed, antiracist intervention. Further study is needed to determine whether EleVATE GC improves perinatal outcomes and promotes health equity.

Hepatitis C and obstetrical morbidity in a substance use disorder clinic: a role for telemedicine?

BACKGROUND: Hepatitis C infection often co-occurs with substance use disorders in pregnancy. Accessing hepatitis C treatment is challenging because of loss to follow-up in the postpartum period, attributable to social and financial barriers to care. Telemedicine has been explored as a means of increasing routine postpartum care, but the potential impact on retention in and completion of care for postpartum hepatitis C has not been assessed. OBJECTIVE: This study aimed to evaluate the impact of hepatitis C on obstetrical morbidity in a substance use disorder-specific prenatal clinic, and the effect of Infectious Disease telemedicine consultation on subsequent treatment delivery. STUDY DESIGN: We performed a retrospective cohort study of all patients in our substance use disorder prenatal clinic from June 2018 to February 2023. Telemedicine consults for hepatitis C diagnoses began in March 2020 and included electronic chart review by Infectious Disease when patients were unable to be seen. Our primary outcome was composite obstetrical morbidity (preterm birth, preeclampsia, fetal growth restriction, fetal anomaly, abruption, postpartum hemorrhage, or chorioamnionitis) compared between patients with and without active hepatitis C. We additionally evaluated rates of completed referral and initiation of hepatitis C treatment before and after implementation of telemedicine consult. RESULTS: A total of 224 patients were included. Of the 222 patients who underwent screening, 71 (32%) were positive for active hepatitis C. Compared with patients without hepatitis C, a higher proportion of patients with hepatitis C were White (80% vs 58%; P=.02), had a history of amphetamine use (61% vs 32%; P<.01), injection drug use (72% vs 38%; P<.01), or overdose (56% vs 29%; P<.01), and were on methadone (37% vs 18%; P<.01). There was no difference in the primary outcome of composite obstetrical morbidity. The rate of hepatitis C diagnosis was not statistically significantly different between the pre- and posttelemedicine cohorts (N=29 [41%], N=42 [27%]), and demographics of hepatitis C virus-positive patients were similar, with most being unemployed, single, and publicly insured. A lower proportion of patients in the posttelemedicine group reported heroin use compared with the pretelemedicine cohort (62% vs 90%; P=.013). After implementation of telemedicine, patients were more likely to attend the visit (19% vs 44%; P=.03), and positive patients were much more likely to receive treatment (14% vs 57%; P<.01); 100% of visits in the posttelemedicine group occurred via telemedicine. There were 7 patients who were prescribed treatment by their obstetrician after chart review by Infectious Disease. CONCLUSION: Patients with and without hepatitis C had similar maternal and neonatal outcomes, with multiple indicators of social and financial vulnerability. Telemedicine Infectious Disease consult was associated with increased follow-up and hepatitis C treatment, and obstetricians were able to directly prescribe. Because patients with substance use disorders and hepatitis C may have increased barriers to care, telemedicine may represent an opportunity for intervention.

The Association between Mode of Transportation Support and Research Study Visit Attendance among Pregnant Patients.

OBJECTIVE: This study aimed to examine the association between transportation assistance and study visits, and explore differences by transportation modality. STUDY DESIGN: This was a secondary analysis of prospective cohort study. We identified patients requesting transportation support for research ultrasound visits and identified controls (1:2 ratio) who did not request support matched for age, race, and insurance type. Conditional logistic regression examined the association between transportation support and mode of transportation with study visit attendance. RESULTS: Transportation support was requested by 57/1,184 (4.8%) participants. Participants that requested transportation support were three times more likely to attend visits than their matched controls (adjusted odds ratio [aOR] 3.16, 95% confidence interval [CI]: 1.76-5.68). Among visits with transportation support, those supported by a ridesharing service had five-fold higher odds of attendance than visits supported with taxi service (aOR 5.06, 95% CI: 1.50-16.98). CONCLUSION: Transportation support, especially a ridesharing service, is associated with improved attendance at research study visits in a sample of predominantly low-income, Black, pregnant participants. Implementing transportation support may be a promising strategy to improve engagement in research studies. KEY POINTS: · Participants utilizing transportation assistance were more likely to attend study appointments.. · Participants using ridesharing had higher likelihood of attendance than those using taxi service.. · Transportation assistance may improve research engagement for historically marginalized people..

Diabetes Group Prenatal Care: A Systematic Review and Meta-analysis.

OBJECTIVE: To estimate the effect of diabetes group prenatal care on rates of preterm birth and large for gestational age (LGA) among patients with diabetes in pregnancy compared with individual diabetes prenatal care. DATA SOURCES: We searched Ovid Medline (1946-), Embase.com (1947-), Scopus (1823-), Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. METHODS OF STUDY SELECTION: We searched electronic databases for randomized controlled trials (RCTs) and observational studies comparing diabetes group prenatal care with individual care among patients with type 2 diabetes mellitus or gestational diabetes mellitus (GDM). The primary outcomes were preterm birth before 37 weeks of gestation and LGA (birth weight at or above the 90th percentile). Secondary outcomes were small for gestational age, cesarean delivery, neonatal hypoglycemia, neonatal intensive care unit admission, breastfeeding at hospital discharge, long-acting reversible contraception (LARC) uptake, and 6-week postpartum visit attendance. Secondary outcomes, limited to the subgroup of patients with GDM, included rates of GDM requiring diabetes medication (A2GDM) and completion of postpartum oral glucose tolerance testing (OGTT). Heterogeneity was assessed with the Cochran Q test and I2 statistic. Random-effects models were used to calculate pooled relative risks (RRs) and weighted mean differences. TABULATION, INTEGRATION, AND RESULTS: Eight studies met study criteria and were included in the final analysis: three RCTs and five observational studies. A total of 1,701 patients were included in the pooled studies: 770 (45.3%) in diabetes group prenatal care and 931 (54.7%) in individual care. Patients in diabetes group prenatal care had similar rates of preterm birth compared with patients in individual care (seven studies: pooled rates 9.5% diabetes group prenatal care vs 11.5% individual care, pooled RR 0.77, 95% CI, 0.59-1.01), which held for RCTs and observational studies. There was no difference between diabetes group prenatal care and individual care in rates of LGA overall (four studies: pooled rate 16.7% diabetes group prenatal care vs 20.2% individual care, pooled RR 0.93, 95% CI, 0.59-1.45) or by study type. Rates of other secondary outcomes were similar between diabetes group prenatal care and individual care, except patients in diabetes group prenatal care were more likely to receive postpartum LARC (three studies: pooled rates 46.1% diabetes group prenatal care vs 34.1% individual care, pooled RR 1.44, 95% CI, 1.09-1.91). When analysis was limited to patients with GDM, there were no differences in rates of A2GDM or postpartum visit attendance, but patients in diabetes group prenatal care were significantly more likely to complete postpartum OGTT (five studies: pooled rate 74.0% diabetes group prenatal care vs 49.4% individual care, pooled RR 1.58, 95% CI, 1.19-2.09). CONCLUSION: Patients with type 2 diabetes and GDM who participate in diabetes group prenatal care have similar rates of preterm birth, LGA, and other pregnancy outcomes compared with those who participate in individual care; however, they are significantly more likely to receive postpartum LARC, and those with GDM are more likely to return for postpartum OGTT. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021279233.

A Rubric to Center Equity in Obstetrics and Gynecology Research.

The Steering Committee for the Obstetrics & Gynecology special edition titled "Racism in Reproductive Health: Lighting a Path to Health Equity" formed a working group to create an equity rubric. The goal was to provide a tool to help researchers systematically center health equity as they conceptualize, design, analyze, interpret, and evaluate research in obstetrics and gynecology. This commentary reviews the rationale, iterative process, and literature guiding the creation of the equity rubric.

Racial and Ethnic Inequities in Buprenorphine and Methadone Utilization Among Reproductive-Age Women with Opioid Use Disorder: an Analysis of Multi-state Medicaid Claims in the USA.

BACKGROUND: Associations between race/ethnicity and medications to treat OUD (MOUD), buprenorphine and methadone, in reproductive-age women have not been thoroughly studied in multi-state samples. OBJECTIVE: To evaluate racial/ethnic variation in buprenorphine and methadone receipt and retention in a multi-state U.S. sample of Medicaid-enrolled, reproductive-age women with opioid use disorder (OUD) at the beginning of OUD treatment. DESIGN: Retrospective cohort study. SUBJECTS: Reproductive-age (18-45 years) women with OUD, in the Merative™ MarketScan® Multi-State Medicaid Database (2011-2016). MAIN MEASURES: Differences by race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, "other" race/ethnicity) in the likelihood of receiving buprenorphine and methadone during the start of OUD treatment (yes/no) were estimated using multivariable logistic regression. Differences in time to medication discontinuation (days) by race/ethnicity were evaluated using multivariable Cox regression. RESULTS: Of 66,550 reproductive-age Medicaid enrollees with OUD (84.1% non-Hispanic White, 5.9% non-Hispanic Black, 1.0% Hispanic, 5.3% "other"), 15,313 (23.0%) received buprenorphine and 6290 (9.5%) methadone. Non-Hispanic Black enrollees were less likely to receive buprenorphine (adjusted odds ratio, aOR = 0.76 [0.68-0.84]) and more likely to be referred to methadone clinics (aOR = 1.78 [1.60-2.00]) compared to non-Hispanic White participants. Across both buprenorphine and methadone in unadjusted analyses, the median discontinuation time for non-Hispanic Black enrollees was 123 days compared to 132 days and 141 days for non-Hispanic White and Hispanic enrollees respectively (χ2 = 10.6; P = .01). In adjusted analyses, non-Hispanic Black enrollees experienced greater discontinuation for buprenorphine and methadone (adjusted hazard ratio, aHR = 1.16 [1.08-1.24] and aHR = 1.16 [1.07-1.30] respectively) compared to non-Hispanic White peers. We did not observe differences in buprenorphine or methadone receipt or retention for Hispanic enrollees compared to the non-Hispanic White enrollees. CONCLUSIONS: Our data illustrate inequities between non-Hispanic Black and non-Hispanic White Medicaid enrollees with regard to buprenorphine and methadone utilization in the USA, consistent with literature on the racialized origins of methadone and buprenorphine treatment.

Intrapartum electronic fetal monitoring features associated with a clinical diagnosis of nonreassuring fetal status.

BACKGROUND: Nonreassuring fetal status detected by continuous electronic fetal monitoring accounts for almost 1 in 4 primary cesarean deliveries. However, given the subjective nature of the diagnosis, there is a need to identify the electronic fetal monitoring patterns that are clinically considered nonreassuring. OBJECTIVE: This study aimed to describe which electronic fetal monitoring features are most commonly associated with first-stage cesarean delivery for nonreassuring fetal status, and to evaluate the risk of neonatal acidemia following cesarean delivery for nonreassuring fetal status. STUDY DESIGN: This was a nested case-control study in a prospectively collected cohort of patients with singleton pregnancies at ≥37 weeks' gestation, admitted in spontaneous labor or for induction of labor from 2010 to 2014 at a single tertiary care center. Patients with preterm pregnancies, multiple gestations, planned cesarean delivery, or nonreassuring fetal status in the second stage of labor were excluded. Cases were identified as having nonreassuring fetal status on the basis of what was documented in the operative note by the delivering physician. Controls were patients without nonreassuring fetal status within 1 hour of delivery. Cases were matched to controls in a 1:2 ratio by parity, obesity, and history of cesarean delivery. Electronic fetal monitoring data were abstracted by credentialed obstetrical research nurses for the 60 minutes before delivery. The primary exposure of interest was the incidence of high-risk category II electronic fetal monitoring features in the 60 minutes before delivery; in particular, the incidence of minimal variability, recurrent late decelerations, recurrent variable decelerations, tachycardia, and >1 prolonged deceleration were compared between groups. We also compared neonatal outcomes between cases and controls, including fetal acidemia (umbilical artery pH <7.1), other umbilical artery gas analytes, and neonatal and maternal outcomes. RESULTS: Of the 8580 patients in the parent study, 714 (8.3%) underwent cesarean delivery for nonreassuring fetal status in the first stage of labor. Patients diagnosed with nonreassuring fetal status requiring cesarean delivery were more likely to have recurrent late decelerations, >1 prolonged deceleration, and recurrent variable decelerations compared with controls. More than 1 prolonged deceleration was associated with 6 times increased rate of nonreassuring fetal status diagnosis resulting in cesarean delivery (adjusted odds ratio, 6.73 [95% confidence interval, 2.47-8.33]). Rates of fetal tachycardia were similar between groups. Minimal variability was less common in the nonreassuring fetal status group compared with controls (adjusted odds ratio, 0.36 [95% confidence interval, 0.25-0.54]). Compared with control deliveries, cesarean delivery for nonreassuring fetal status was associated with nearly 7 times higher risk of neonatal acidemia (7.2% vs 1.1%; adjusted odds ratio, 6.93 [95% confidence interval, 3.83-12.54]). Composite neonatal morbidity and composite maternal morbidity were more likely among patients delivered for nonreassuring fetal status in the first stage (3.9% vs 1.1%; adjusted odds ratio, 5.70 [2.60-12.49]; and 13.3% vs 8.0%; adjusted odds ratio, 1.99 [1.41-2.80]). CONCLUSION: Although multiple category II electronic fetal monitoring features have been traditionally linked to acidemia, the presence of recurrent late decelerations, recurrent variable decelerations, and prolonged decelerations seemed to concern obstetricians enough to surgically intervene for nonreassuring fetal status. A clinical intrapartum diagnosis of nonreassuring fetal status in the setting of these electronic fetal monitoring features is also associated with increased risk of acidemia, suggesting clinical validity to the diagnosis of nonreassuring fetal status.

Heterogeneity in management of category II fetal tracings: data from a multihospital healthcare system.

BACKGROUND: Electronic fetal monitoring is widely used to identify and intervene in suspected fetal hypoxia and/or acidemia. Category II fetal heart rate tracings are the most common class of fetal monitoring in labor, and intrauterine resuscitation is recommended given the association of category II fetal heart rate tracings with fetal acidemia. However, limited published data are available to guide intrauterine resuscitation technique selection, leading to heterogeneity in the response to category II fetal heart rate tracings. OBJECTIVE: This study aimed to characterize approaches to intrauterine resuscitation in response to category II fetal heart rate tracings. STUDY DESIGN: This was a survey study administered to labor unit nurses and delivering clinicians (physicians and midwives) across 7 hospitals in a Midwestern healthcare system spanning 2 states. The survey posed 3 category II fetal heart rate tracing scenarios (recurrent late decelerations, minimal variability, and recurrent variable decelerations) and asked participants to select first- and second-line intrauterine resuscitation management strategies. The participants were asked to quantify the level of influence certain factors have on their choice using a scale from 1 to 5. Intrauterine resuscitation strategy selection was compared by clinical role and hospital type (nurses vs delivering clinicians and university-affiliated hospital vs non-university-affiliated hospital). RESULTS: Of 610 providers invited to take the survey, 163 participated (response rate of 27%): 37% of participants from university-affiliated hospitals, 62% of nurses, and 37% of physicians. Maternal repositioning was the most selected first-line strategy, regardless of the type of category II fetal heart rate tracing. First-line management varied by clinical role and hospital affiliation for each fetal heart rate tracing scenario, particularly for minimal variability, which was associated with the most heterogeneity in the first-line approach. Previous experience and recommendations from professional societies were the most influential factors in intrauterine resuscitation selection overall. Of note, 16.5% of participants reported that published evidence did not influence their choice at all. Participants from a university-affiliated hospital were more likely than participants from a non-university-affiliated hospital to consider patient preference when selecting an intrauterine resuscitation technique. Nurses and delivering clinicians differed significantly in the rationale for management choices: nurses were more often influenced by advice from other healthcare providers on the team (P<.001), whereas delivering clinicians were more influenced by literature (P=.02) and ease of technique (P=.02). CONCLUSION: There was significant heterogeneity in the management of category II fetal heart rate tracing. In addition, motivations for choice in intrauterine resuscitation technique varied by hospital type and clinical role. These factors should be considered when creating fetal monitoring and intrauterine resuscitation protocols.

The Impact of Cervical Effacement at Time of Amniotomy in Patients Undergoing Induction of Labor.

OBJECTIVE: There is evidence to suggest that early amniotomy during induction of labor is advantageous. However, following cervical ripening balloon removal, the cervix remains less effaced and the utility of amniotomy in this setting is less clear. We investigated whether cervical effacement at the time of amniotomy impacts outcomes among nulliparas undergoing induction of labor. STUDY DESIGN: This was a secondary analysis of a prospective cohort of singleton, term, nulliparous patients at a tertiary care center undergoing induction of labor and amniotomy. The primary outcome was completion of the first stage of labor. Secondary outcomes were vaginal delivery and postpartum hemorrhage. Outcomes were compared between patients with cervical effacement ≤50% (low effacement) and >50% (high effacement) at time of amniotomy. Multivariable logistic regression was used calculate risk ratios (RR) to adjust for confounders including cervical dilation. Stratified analysis was performed in patients with cervical ripening balloon use. A post hoc sensitivity analysis was performed to further control for cervical dilation. RESULTS: Of 1,256 patients, 365 (29%) underwent amniotomy at low effacement. Amniotomy at low effacement was associated with reduced likelihood of completing the first stage (aRR: 0.87 [95% confidence interval, CI: 0.78-0.95]) and vaginal delivery (aRR: 0.87 [95% CI: 0.77-0.96]). Although amniotomy at low effacement was associated with lower likelihood of completing the first stage in all-comers, those who had amniotomy performed at low effacement following cervical ripening balloon expulsion were at the highest risk (aRR: 0.84 [95% CI: 0.69-0.98], p for interaction = 0.04) In the post hoc sensitivity analysis, including patients who underwent amniotomy at 3- or 4-cm dilation, low cervical effacement remained associated with a lower likelihood of completing the first stage of labor. CONCLUSION: Low cervical effacement at time of amniotomy, particularly following cervical ripening balloon expulsion, is associated with a lower likelihood of successful induction. KEY POINTS: · Low cervical effacement at amniotomy was associated with lower rates of complete dilation.. · Effacement at amniotomy is especially important for patients who had a cervical ripening balloon.. · Providers should consider cervical effacement when timing amniotomy for nulliparous term patients..

Initiation and Treatment Discontinuation of Medications for Opioid Use Disorder in Pregnant People Compared With Nonpregnant People.

OBJECTIVE: To examine the association between pregnancy and medications for opioid use disorder (MOUD) initiation and discontinuation among reproductive-aged people receiving treatment for opioid use disorder (OUD) in the United States. METHODS: We conducted a retrospective cohort study of people with gender recorded as female, aged 18-45 years, in the Merative TM MarketScan ® Commercial and Multi-State Medicaid Databases (2006-2016). Opioid use disorder and pregnancy status were identified based on inpatient or outpatient claims for established International Classification of Diseases, Ninth and Tenth Revision diagnosis and procedure codes. The main outcomes were buprenorphine and methadone initiation and discontinuation, determined by using pharmacy and outpatient procedure claims. Analyses were conducted at the treatment episode level. Adjusting for insurance status, age, and co-occurring psychiatric and substance use disorders, we used logistic regression to estimate MOUD initiation and used Cox regression to estimate MOUD discontinuation. RESULTS: Our sample included 101,772 reproductive-aged people with OUD, encompassing 155,771 treatment episodes (mean age 30.8 years, 64.4% Medicaid insurance, 84.1% White), of whom 2,687 (3.2%, encompassing 3,325 episodes) were pregnant. In the pregnant group, 51.2% of treatment episodes (1,703/3,325) involved psychosocial treatment without MOUD, in comparison with 61.1% (93,156/152,446) in the nonpregnant comparator group. In adjusted analyses assessing likelihood of initiation for individual MOUD, pregnancy status was associated with an increase in buprenorphine (adjusted odds ratio [aOR] 1.57, 95% CI 1.44-1.70) and methadone initiation (aOR 2.04, 95% CI 1.82-2.27). Discontinuation rates of MOUD at 270 days were high for both buprenorphine (72.4% for nonpregnant episodes vs 59.9% for pregnant episodes) and methadone (65.7% for nonpregnant episodes vs 54.1% for pregnant episodes). Pregnancy was associated with a decreased likelihood of discontinuation at 270 days for both buprenorphine (adjusted hazard ratio [aHR] 0.71, 95% CI 0.67-0.76) and methadone (aHR 0.68, 95% CI 0.61-0.75), in comparison with nonpregnant status. CONCLUSION: Although a minority of reproductive-aged people with OUD in the United States are initiated on MOUD, pregnancy is associated with a significant increase in treatment initiation and a reduced risk of medication discontinuation.

Video Instruction for Pushing in the Second Stage: a randomized controlled trial.

BACKGROUND: The second stage of labor requires active patient engagement. Previous studies suggest that coaching can influence the second stage of labor duration. However, a standardized education tool has not been established, and patients face many barriers to accessing childbirth education before delivery. OBJECTIVE: This study aimed to investigate the effect of an intrapartum video pushing education tool on the second stage of labor duration. STUDY DESIGN: This was a randomized controlled trial of nulliparous patients with singleton pregnancies ≥37 weeks of gestation admitted for induction of labor or spontaneous labor with neuraxial anesthesia. Patients were consented on admission and block randomized in active labor to 1 of 2 arms in a 1:1 ratio. The study arm viewed a 4-minute video before the second stage of labor on what to anticipate in the second stage of labor and pushing techniques. The control arm received the standard of care: bedside coaching at 10 cm dilation from a nurse or physician. The primary outcome was second stage of labor duration. The secondary outcomes were birth satisfaction (using the Modified Mackey Childbirth Satisfaction Rating Scale), mode of delivery, postpartum hemorrhage, clinical chorioamnionitis, neonatal intensive care unit admission, and umbilical artery gases. Of note, 156 patients were needed to detect a 20% decrease in the second stage of labor duration with 80% power, 2-sided alpha level of .05, and 10% loss after randomization. Funding was provided by the Lucy Anarcha Betsy award from the division of clinical research at Washington University. RESULTS: Of 161 patients, 81 were randomized to standard of care, and 80 were randomized to intrapartum video education. Among these patients, 149 progressed to the second stage of labor and were included in the intention-to-treat analysis: 69 in the video group and 78 in the control group. Maternal demographics and labor characteristics were similar between groups. The second stage of labor duration was statistically similar between the video arm (61 minutes [interquartile range, 20-140]) and the control arm (49 minutes [interquartile range, 27-131]) (P=.77). There was no difference in mode of delivery, postpartum hemorrhage, clinical chorioamnionitis, neonatal intensive care unit admission, or umbilical artery gases between groups. Although the overall birth satisfaction score on the Modified Mackey Childbirth Satisfaction Rating Scale was similar between groups, patients in the video group rated their "level of comfort during birth" and "attitude of the doctors in birth" significantly higher or more positively than patients in the control group (P<.05 for both). CONCLUSION: Intrapartum video education was not associated with a shorter second stage of labor duration. However, patients who received video education reported a higher level of comfort and a more favorable perception of their physician, suggesting that video education may be a helpful tool to improve the birth experience.

Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic.

Exclusion of special populations (older adults; pregnant women, children, and adolescents; individuals of lower socioeconomic status and/or who live in rural communities; people from racial and ethnic minority groups; individuals from sexual or gender minority groups; and individuals with disabilities) in research is a pervasive problem, despite efforts and policy changes by the National Institutes of Health and other organizations. These populations are adversely impacted by social determinants of health (SDOH) that reduce access and ability to participate in biomedical research. In March 2020, the Northwestern University Clinical and Translational Sciences Institute hosted the "Lifespan and Life Course Research: integrating strategies" "Un-Meeting" to discuss barriers and solutions to underrepresentation of special populations in biomedical research. The COVID-19 pandemic highlighted how exclusion of representative populations in research can increase health inequities. We applied findings of this meeting to perform a literature review of barriers and solutions to recruitment and retention of representative populations in research and to discuss how findings are important to research conducted during the ongoing COVID-19 pandemic. We highlight the role of SDOH, review barriers and solutions to underrepresentation, and discuss the importance of a structural competency framework to improve research participation and retention among special populations.

Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial.

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

Association between Elevated Intrauterine Resting Tone during Labor and Neonatal Morbidity.

OBJECTIVE: Internal contraction monitoring provides a quantitative assessment of intrauterine resting tone. During the course of labor, elevated intrauterine resting tone may be identified. We hypothesized that elevated intrauterine resting tone could lead to compression of the spiral arteries, thus limiting uterine blood flow and resulting in neonatal compromise. Therefore, our objective was to assess the association between elevated resting tone during labor and neonatal morbidity. STUDY DESIGN: This was a secondary analysis of a prospective cohort study of singleton deliveries at ≥37 weeks of gestation. Patients with ruptured membranes and an intrauterine pressure catheter in place for at least 30 minutes prior to delivery were included. Intrauterine resting tone was calculated as the average baseline pressure between contractions during the 30 minutes prior to delivery. The study group had elevated intrauterine resting tone, defined as intrauterine resting tone ≥75th percentile (≥12.3 mm Hg). Primary outcome was composite neonatal morbidity: hypoxic-ischemic encephalopathy, hypothermia treatment, intubation, seizures, umbilical arterial pH ≤7.1, oxygen requirement, or death. Secondary outcomes included umbilical artery pH <7.2, lactate ≥4 mmol/L, and rates of neonatal intensive care unit admission. RESULTS: Of the 8,580 patients in the cohort, 2,210 (25.8%) met the inclusion criteria. The median intrauterine resting tone was 9.7 mm Hg (interquartile range: 7.3-12.3 mm Hg). Elevated resting tone was associated with a shorter median duration of the first stage of labor (10.0 vs. 11.0 hours, p < 0.01) and lower rates of labor induction and oxytocin augmentation (p < 0.01). Neonatal composite morbidity was higher among patients with elevated intrauterine resting tone (5.1 vs. 2.9%, p = 0.01). After adjusting for chorioamnionitis and amnioinfusion, elevated intrauterine resting tone was associated with increased risk of neonatal morbidity (adjusted odds ratio: 1.70, 95% confidence interval: 1.06-2.74). CONCLUSION: Our findings suggest that elevated intrauterine resting tone is associated with increased risk of neonatal composite morbidity. KEY POINTS: · Higher intrauterine resting tone is associated with increased risk of neonatal morbidity.. · Elevated intrauterine tone can negatively impact umbilical artery pH and lactate levels.. · If elevated intrauterine pressure is noted, we recommend close monitoring of fetal status..