Obstetric Anesthesiology Research

Abstract

To compare the incidence of neurodevelopmental disorders among children with prenatal exposure to buprenorphine versus methadone.Population based cohort study.US nationwide Medicaid data on >2.5 million live births from 2000 to 2018.18 612 pregnancies exposed to buprenorphine or methadone, of which 587 were excluded from the analysis owing to exposure to the comparator drug.The primary outcome was a composite of neurodevelopmental disorders (autism spectrum disorder, attention deficit/hyperactivity disorder, developmental speech or language disorder, developmental coordination disorder, behavioural disorder, learning difficulty, or intellectual disability). Individual neurodevelopmental disorders were considered secondary outcomes. Cumulative incidences were obtained using Kaplan-Meier analyses, and hazard ratios using Cox proportional hazards regression. Propensity score overlap weighting was applied to adjust for confounding, including personal characteristics, maternal medical and mental health comorbidities, exposure to medications and other substances, proxies for severity of opioid use disorder, healthcare utilisation, and adequacy of prenatal care utilisation.12 635 children were exposed to buprenorphine and 5390 to methadone prenatally. The crude cumulative incidence of any neurodevelopmental disorder at age 8 years among those exposed to buprenorphine was 34% (95% confidence interval (CI) 30% to 38%) and among those exposed to methadone was 33% (29% to 37%). Adjusted analyses suggested slightly lower hazards of any neurodevelopmental disorder associated with exposure to buprenorphine versus methadone (adjusted hazard ratio 0.81, 95% CI 0.70 to 0.94). Similar results were obtained for the individual neurodevelopmental disorders such as attention deficit/hyperactivity disorder (0.89, 0.65 to 1.21) and autism spectrum disorder (0.74, 0.46 to 1.21). With prevalent use, prenatal exposure to buprenorphine was associated with lower hazards of any neurodevelopmental disorder compared with prenatal exposure to methadone (adjusted hazard ratio 0.62, 0.51 to 0.76). This association was not observed with treatment initiation during pregnancy (adjusted hazard ratio 1.13, 0.90 to 1.42). Further sensitivity analyses indicated results consistent with no increased risk of neurodevelopmental disorders among pregnancies exposed to buprenorphine versus methadone.The findings of this study suggest no increased risk of long term adverse neurodevelopmental outcomes among children with prenatal exposure to buprenorphine versus methadone, further supporting buprenorphine as a safe treatment option for opioid use disorder during pregnancy.

View details for DOI 10.1136/bmj-2025-087321

View details for PubMedID 41985931

View details for PubMedCentralID PMC13081224

View details for DOI 10.1056/NEJMp2511434

View details for PubMedID 41283218

View details for DOI 10.1001/jama.2025.13225

View details for PubMedID 40864437

Abstract

Buprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product.To compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone.Population-based cohort study using health care utilization data from Medicaid-insured beneficiaries in the US from 2000 to 2018. The cohort was restricted to pregnant individuals linked to their liveborn infants, with maternal Medicaid enrollment from 3 months before pregnancy to 1 month after delivery and infant enrollment for the first 3 months after birth, unless they died sooner.Use of buprenorphine with naloxone vs buprenorphine alone during the first trimester based on outpatient dispensings.Outcomes included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity. Confounder-adjusted risk ratios were calculated using propensity score overlap weights.This study identified 3369 pregnant individuals exposed to buprenorphine with naloxone during the first trimester (mean [SD] age, 28.8 [4.6] years) and 5326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester (mean [SD] age, 28.3 [4.5] years). When comparing buprenorphine combined with naloxone with buprenorphine alone, a lower risk for neonatal abstinence syndrome (absolute risk, 37.4% vs 55.8%; weighted relative risk, 0.77 [95% CI, 0.70-0.84]) and a modestly lower risk for neonatal intensive care unit admission (absolute risk, 30.6% vs 34.9%; weighted relative risk, 0.91 [95% CI, 0.85-0.98]) and small for gestational age (absolute risk, 10.0% vs 12.4%; weighted relative risk, 0.86 [95% CI, 0.75-0.98]) was observed. For maternal morbidity, the comparative rates were 2.6% vs 2.9%, respectively, and the weighted relative risk was 0.90 (95% CI, 0.68-1.19). No differences were observed with respect to major congenital malformations overall, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery. Results were consistent across sensitivity analyses.There were similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. For the outcomes assessed, compared with buprenorphine alone, buprenorphine with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for the treatment of opioid use disorder in pregnancy, affirming flexibility in collaborative treatment decision-making.

View details for DOI 10.1001/jama.2024.11501

View details for PubMedID 39133511

View details for DOI 10.1001/jama.2024.5003

View details for PubMedID 38648036

View details for PubMedCentralID PMC11036309

Abstract

Existing patient-reported outcome measures (PROMs) evaluating outpatient postpartum recovery lack content validity and were mostly not designed for this population. A Delphi process was performed, aiming to develop a patient-reported outcome measure for outpatient postpartum recovery and then evaluate it in a multicenter cohort study.Development of the Stanford Obstetric Recovery Checklist (STORK) involved 3 phases: (1) postpartum recovery questions were identified in published reviews; (2) after institutional review board approval, 16 multidisciplinary experts and patient stakeholders participated in 3 Delphi rounds (January 11 to April 12, 2021) to select items, resulting in the development of STORK (47 items; total score range, 0-188, with 0 indicating the worst recovery and 188 indicating the best recovery); and (3) cognitive debriefing interviews were conducted with 10 postpartum individuals to finalize STORK items. Individuals then completed STORK during their inpatient stay and at 2, 6, and 12 weeks post partum in a prospective, 3-center, US longitudinal cohort study conducted from June 13, 2022, to February 28, 2023. Recruitment occurred until 300 six-week STORK surveys were completed. STORK was evaluated at 6 weeks for validity (ability to measure recovery), reliability, and responsiveness. Validity included (1) structural validity (exploratory factor analysis using root mean square residual [RMSR]; <0.08 indicates a good fit); (2) convergent validity (correlation with global health visual analog scale score [GHVAS; scale, 0-100] and EuroQoL Five-Dimensions Three-Levels [EQ-5D-3L]); (3) discriminant validity (mean difference in STORK scores with GHVAS <70 vs ≥70); and (4) confirmatory telephone interviews with postpartum individuals scoring the highest and lowest 10th percentiles of STORK scores. Reliability (consistency of STORK scores) was evaluated using Cronbach α, interitem correlation, split-half reliability, and floor and ceiling effects. Responsiveness (ability of STORK to detect changes in recovery over time) was evaluated using percentage change in score from baseline to 12 weeks.A total of 525 individuals were recruited after all delivery modes (response rate, 62% [324 of 525] at 6 weeks); 498 (mean [SD] age, 33.3 [4.9] years) completed baseline inpatient postpartum surveys. STORK demonstrated validity: (1) a 4-factor model was the best fit (RMSR = 0.05); (2) correlation with GHVAS scores was ρ = 0.52 (95% CI, 0.43-0.61), and correlation with EQ-5D-3L scores was ρ = -0.67 (95% CI, -0.76 to -0.63); (3) STORK was able to discriminate between patients reporting good and poor recovery (good recovery: median STORK score, 151 [IQR, 136-163] vs poor recovery: median STORK score, 129 [IQR, 107-148]; P < .001); and (4) the highest and lowest scores corresponded to subjective assessments. STORK demonstrated reliability (Cronbach α = 0.92; interitem correlation r = 0.20; and split-half reliability ρ = 0.98). It also demonstrated responsiveness: percentage increases in overall STORK scores from baseline to week 12 were 19% after spontaneous vaginal delivery, 31% after operative vaginal delivery, 27% after scheduled cesarean delivery, and 20% after nonscheduled cesarean delivery (P < .001).In this cohort study of US individuals, STORK was found to be a valid, reliable, and responsive measure of outpatient postpartum recovery. Future clinical trials are needed to determine its clinical utility.

View details for DOI 10.1001/jamanetworkopen.2025.5713

View details for PubMedID 40244582

Abstract

To better understand outcomes in postpartum patients who receive peripartum anaesthetic interventions, we aimed to assess quality of recovery metrics following childbirth in a UK-based multicentre cohort study. This study was performed during a 2-week period in October 2021 to assess in- and outpatient post-delivery recovery at 1 and 30 days postpartum. The following outcomes were reported: obstetric quality of recovery 10-item measure (ObsQoR-10); EuroQoL (EQ-5D-5L) survey; global health visual analogue scale; postpartum pain scores at rest and movement; length of hospital stay; readmission rates; and self-reported complications. In total, 1638 patients were recruited and responses analysed from 1631 (99.6%) and 1282 patients (80%) at one and 30 days postpartum, respectively. Median (IQR [range]) length of stay postpartum was 39.3 (28.5-61.0 [17.7-513.4]), 40.3 (28.5-59.1 [17.8-220.9]), and 35.9 (27.1-54.1 [17.9-188.4]) h following caesarean, instrumental and vaginal deliveries, respectively. Median (IQR [range]) ObsQoR-10 score was 75 ([62-86] 4-100) on day 1, with the lowest ObsQoR-10 scores (worst recovery) reported by patients undergoing caesarean delivery. Of the 1282 patients, complications within the first 30 days postpartum were reported by 252 (19.7%) of all patients. Readmission to hospital within 30 days of discharge occurred in 69 patients (5.4%), with 49 (3%) for maternal reasons. These data can be used to inform patients regarding expected recovery trajectories; facilitate optimal discharge planning; and identify populations that may benefit most from targeted interventions to improve postpartum recovery experience.

View details for DOI 10.1111/anae.16039

View details for PubMedID 37226593

Abstract

BACKGROUND: Heterogeneity among reported outcomes from enhanced recovery after cesarean delivery impact studies is high. This study aimed to develop a standardized enhanced recovery core outcome set for use in future enhanced recovery after cesarean delivery studies.METHODS: An international consensus study involving physicians, patients and a director of Midwifery and Nursing Services, was conducted using a three-round modified Delphi approach (2 rounds of electronic questionnaires and a 3rd round e-discussion), to produce the core outcome set. An initial list of outcomes was based on a previously published systematic review. Consensus was obtained for the final core outcome set, including definitions for key terms, and preferred units of measurement. Strong consensus was defined as ≥70% agreement and weak consensus as 50-69% agreement. Of the 64 stakeholders who were approached, 32 agreed to participate. All 32, 31 and 26 stakeholders completed Rounds 1, 2 and 3, respectively.RESULTS: The number of outcomes in the final core outcome set was reduced from 98 to 15. Strong consensus (≥70% stakeholder agreement) was achieved for 15 outcomes. The core outcome set included: length of hospital stay; compliance with enhanced recovery protocol; maternal morbidity (hospital re-admissions or unplanned consultations); provision of optimal analgesia (maternal satisfaction, compliance with analgesia, opioid consumption / requirement and incidence of nausea or vomiting); fasting times; breastfeeding success; and times to mobilization and urinary catheter removal. The Obstetric Quality of Recovery-10 item composite measure was also included in the final core outcome set. Areas identified as requiring further research included readiness for discharge and analysis of cost savings.CONCLUSIONS: Results from an international consensus to develop a core outcome set for enhanced recovery after cesarean delivery are presented. These are outcomes that could be considered when designing future enhanced recovery studies.

View details for DOI 10.1097/ALN.0000000000004263

View details for PubMedID 35511169

Abstract

Outpatient postpartum recovery is an underexplored area of obstetrics. There is currently no consensus regarding which patient-reported outcome measure (PROM) clinicians and researchers should use to evaluate postpartum recovery.To evaluate PROMs of outpatient postpartum recovery using Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.An initial literature search performed in July 2019 identified postpartum recovery PROMs and validation studies. A secondary search in July 2020 identified additional validation studies. Both searches were performed using 4 databases (Web of Science, Embase, PubMed, and CINAHL), with no date limiters. Studies with PROMs evaluating more than 3 proposed outpatient postpartum recovery domains were considered. Studies were included if they assessed any psychometric measurement property of the included PROMs in the outpatient postpartum setting. The PROMs were assessed for the following 8 psychometric measurement properties, as defined by COSMIN: content validity, structural validity, internal consistency, cross-cultural validity and measurement invariance, reliability, measurement error, hypothesis testing, and responsiveness. Psychometric measurement properties were evaluated in each included study using the COSMIN criteria by assessing (1) the quality of the methods (very good, adequate, doubtful, inadequate, or not assessed); (2) overall rating of results (sufficient, insufficient, inconsistent, or indeterminate); (3) level of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations assessment tool; and (4) level of recommendation, which included class A (recommended for use; showed adequate content validity with at least low-quality evidence for sufficient internal consistency), class B (not class A or class C), or class C (not recommended).In total, 15 PROMs (7 obstetric specific and 8 non-obstetric specific) were identified, evaluating outpatient postpartum recovery in 46 studies involving 19 165 women. The majority of psychometric measurement properties of the included PROMs were graded as having very-low-level or low-level evidence. The best-performing PROMs that received class A recommendations were the Maternal Concerns Questionnaire, the Postpartum Quality of Life tool, and the World Health Organization Quality of Life-BREF. The remainder of the evaluated PROMs had insufficient evidence to make recommendations regarding their use (and received class B recommendations).This review found that the best-performing PROMs currently available to evaluate outpatient postpartum recovery were the Maternal Concerns Questionnaire, the Postpartum Quality of Life tool, and the World Health Organization Quality of Life-BREF; however, these tools all had significant limitations. This study highlights the need to focus future efforts on robustly developing and validating a new PROM that may comprehensively evaluate outpatient postpartum recovery.

View details for DOI 10.1001/jamanetworkopen.2021.11600

View details for PubMedID 34042993

Abstract

Despite the global delivery rate being approximately 259 deliveries per minute in 2018, postpartum recovery remains poorly defined.To identify validated patient-reported outcome measures (PROMs) used to assess outpatient and inpatient postpartum recovery, evaluate frequency of PROM use, report the proportion of identified PROMs used within each recovery domain, report the number of published studies within each recovery domain, summarize descriptive data (country of origin, year of study, and journal specialty) for published studies using PROMs to evaluate postpartum recovery, and report PROMs used to evaluate global postpartum recovery.This study followed PRISMA-ScR guidelines. A literature search of 4 databases (MEDLINE through PubMed, Embase, Web of Science, and CINAHL) was performed on July 1, 2019, to identify PROMs used to evaluate 12 author-defined domains of postpartum recovery. All psychometrically evaluated PROMs used to evaluate inpatient or outpatient postpartum recovery after all delivery modes were included.From 8008 screened titles and abstracts, 573 studies (515 outpatient and 58 inpatient) were identified in this review. A total of 201 PROMs were used to assess recovery for outpatient studies and 73 PROMs were used to assess recovery for inpatient studies. The top 5 domains (with highest to lowest numbers of PROMs) used to assess outpatient recovery were psychosocial distress (77 PROMs), surgical complications (26 PROMs), psychosocial support (27 PROMs), motherhood experience (16 PROMs), and sexual function (13 PROMs). Among inpatient studies, the top 5 domains were psychosocial distress (32 PROMs), motherhood experience (7 PROMs), psychosocial support (5 PROMs), fatigue (5 PROMs), and cognition (3 PROMs). The 3 most frequently used PROMs were the Edinburgh Postnatal Depression Scale (267 studies), Short-Form 36 Health Questionnaire (global recovery assessment; 40 studies), and Female Sexual Function Index (35 studies). A total of 24 global recovery PROMs were identified among all included studies. Most studies were undertaken in the United States within the last decade and were published in psychiatry and obstetrics and gynecology journals.Most PROMs identified in this review evaluated a single domain of recovery. Future research should focus on determining the psychometric properties of individual and global recovery PROMs identified in this review to provide recommendations regarding optimum measures of postpartum recovery.

View details for DOI 10.1001/jamanetworkopen.2020.5540

View details for PubMedID 32442292