Abstract Background Opioid Use Disorder (OUD) has emerged as a critical public health issue among pregnant and postpartum individuals. To address this concern, it is of utmost importance that healthcare institutions, community-based programs, and other agencies collaborate to improve the support offered to the concerned population in their OUD recovery journey. A social network analysis was conducted to understand collaborations among multisectoral agencies serving or having potential to serve pregnant and postpartum individuals with OUD. Methods Collaborations among agencies (n = 79), including three Continuous And Data-drivEN CarE (CADENCE) program clinics, in a large Florida county were mapped. A cross-sectional web-based survey was distributed to these agencies to capture inter-agency collaborations, including services provided (e.g., housing, transportation, etc.), interaction frequency, and perceptions of partner agency confidence, dependence, and value. Open-ended questions identified champion agencies and needs of agencies to better serve the population. Network maps of the agencies were generated to characterize the nature of existing collaborations and identify opportunities for strengthening interagency coordination. Results Twenty-six out of 79 enlisted agencies (33%) responded, describing connections with 72 enlisted agencies. The social network analysis of total 376 ties among these agencies demonstrated low density (0.108) but high clustering (0.637), indicating a connected core with tightly knit subgroups and cross-sector bridges especially through social services. CADENCE clinics were inter-linked; CADENCE Co-located pediatric/ psychiatric/Maternal-Fetal Medicine clinic was most connected (38 ties), followed by CADENCE Outpatient Prenatal Care clinic (16 ties), and CADENCE Addiction Medicine (9 ties). Collaboration frequency varied, with 34% of referral ties used only once a year or less, 13% used daily, and 17% never used. Agencies reported having confidence in 82% of collaborations, yet more than half (56%) were considered non-essential (no or little dependency) to achieving patient care goals. Qualitative insights emphasized integrated, trauma-informed care, standardized referral pathways and shared data; destigmatization, and harm reduction; simpler resource navigation and supports for housing and transportation. Conclusion Overall, the county possesses a multisector perinatal OUD network that is yet underutilized. Strengthening structured referrals, interoperability, and wraparound, stigma-free services leveraging CADENCE could reduce fragmentation and improve maternal-infant outcomes. Trial registration ClinicalTrails.gov (NCT05609669). November 02, 2022.
Abstract Introduction In the past decade, hepatitis C virus (HCV) infections among pregnant women increased dramatically in the United States, rising in parallel with the opioid crisis and increasing the number of children at risk for HCV. People with HCV infection that remains untreated are also at increased risk of cirrhosis, liver cancer, and death. Objective To describe timing of HCV testing during pregnancy and postpartum HCV treatment among women with opioid use disorder (OUD). Methods This analysis draws from the MATernaL and Infant clinical NetworK (MAT‐LINK) surveillance system's cohort of women with OUD during pregnancy, which is collected from electronic health records of seven healthcare systems. Women were included if they had OUD during pregnancy and a known pregnancy outcome during January 1, 2014–August 31, 2021. Antenatal HCV testing was examined by characteristics of pregnant women (including age, race, ethnicity, insurance, urbanicity, parity, and medication for OUD) using multinomial regression. Hepatitis C diagnosis (positive antibody or nucleic acid test or diagnostic code) and postpartum treatment were also examined. Results Among the 5533 pregnancies in this cohort, 1506 (27.2%) had no testing or diagnostic code for hepatitis C including 1296 who received prenatal care. Among 910 pregnancies with no prenatal care, 700 (76.9%) had HCV testing or diagnostic codes. Among pregnancies with HCV testing or diagnostic codes, 55.8% had a hepatitis C diagnosis. Women were more likely to have HCV testing if they were White or Hispanic, had government‐funded insurance, or received medication for OUD during the pregnancy. From five clinical sites with prescription information available, 9.7% (n = 81/836) of those with a detectable viral load had a direct‐acting antiviral prescription in the first year postpartum. Conclusion Women with OUD during pregnancy have a high burden of hepatitis C. Despite national recommendations, gaps remain in HCV testing during pregnancy and HCV treatment postpartum. HCV testing among women with no prenatal care indicates that testing is occurring outside of traditional prenatal care settings. Receiving medication for OUD was associated with being tested for HCV during pregnancy. Improved HCV testing, treatment, and management for pregnant women with OUD represent opportunities for improving overall health and eliminating HCV infection.
BackgroundOpioid use disorder during pregnancy (OUD) continues to pose a significant public health challenge, requiring well-designed interventions. This scoping review identifies effective prenatal OUD interventions to promote the use of evidence-based approaches, such as medication for opioid use disorder (MOUD), and inform future research and clinical practice.MethodsWe searched PubMed, Embase, CINAHL, Scopus, and Web of Science for interventions for OUD during pregnancy from 2013 to 2023. Exclusions were non-English studies, animal research, non-prenatal interventions, pharmacological trials, and studies outside the U.S. Data were extracted on intervention context, sample, study aims, and results. We categorized each intervention by the socioecological model (SEM) level of implementation and applied the RE-AIM framework to evaluate reach, effectiveness, adoption, implementation, and maintenance.ResultsAfter review of 1,381 articles, a total of 31 intervention studies were included. Fourteen studies (45%) included over 75% non-Hispanic white participants. Seventeen studies (55%) were conducted at the individual level, six (19%) at the interpersonal level, and eight (26%) at the society/community level. Individual-level interventions focused on coordinated clinical care models, detoxification/tapering from (MOUD), and prenatal education. Interpersonal interventions included clinician education and group therapy. Community-level interventions targeted regional coordination of services, while society level studies examined the impact of policy change on MOUD access.ConclusionWe identified a wide range of prenatal OUD interventions with varying approaches and summarized each by SEM implementation level. While MOUD access remains crucial, community-based interventions that address broader social determinants, and societal barriers may have the greatest impact in improving maternal health outcomes.Systematic Review Registrationhttps://osf.io/, identifier 10.17605/OSF.IO/8ZUAB.
Objective:To examine the likelihood of experiencing an overdose among women receiving any buprenorphine (with or without naloxone) compared to women receiving methadone during pregnancy. Methods:Data from the MATernaL and Infant clinical NetworK (MAT-LINK), a longitudinal surveillance system of pregnant woman-child dyads using electronic health records (EHRs), were analyzed. Women from geographically diverse US clinical sites who had a diagnosis of opioid use disorder (OUD) during pregnancy, were prescribed medication for opioid use disorder (MOUD), and had a known birth outcome occurring between January 1, 2014 and August 31, 2021 were included. The Andersen-Gill Cox regression model for recurrent events with robust standard errors was used to model the effect of MOUD type by trimester on time to overdose or date of pregnancy outcome and calculate adjusted hazard ratios (aHRs). Results:Among the 3682 pregnancies included in this analysis, 46 (1.2%) had at least one EHR-documented overdose. None of the overdoses were fatal. In adjusted models, no differences in overdose were observed between pregnancies in which buprenorphine was prescribed or administered compared to pregnancies in which methadone was prescribed or administered (any drug overdose: aHR, 0.62; 95% CI, 0.31-1.23; opioid-involved overdose: aHR, 0.49; 95% CI, 0.18-1.30). In a trimester-specific sub-analysis of pregnancies with at least two MOUD prescriptions or administrations, taking buprenorphine in the third trimester resulted in a decreased likelihood of any drug overdose (aHR, 0.43; 95% CI, 0.20-0.93) and opioid-involved overdose (aHR, 0.32; 95% CI, 0.11-0.92) compared with methadone. Conclusion:It is important that women with OUD are initiated on the medication that works best for them as early as possible during pregnancy and that reinforcement of the importance of MOUD occurs throughout pregnancy, paying special attention to disruptions in treatment during the third trimester that might increase risk for overdose.
Importance:Infants with neonatal opioid withdrawal syndrome (NOWS) who receive pharmacologic treatment are traditionally treated with a scheduled opioid taper. An alternate approach, symptom-based dosing, may better align treatment with withdrawal severity. Objective:To compare time from birth to medical readiness for discharge for infants with moderate to severe withdrawal treated with either a symptom-based dosing or scheduled opioid taper approach. Design, Setting, and Participants:In this cluster, crossover randomized clinical trial with run-in period, 23 US hospitals cared for infants using the Eat, Sleep, Console approach (ESC) or Finnegan-based care (a comprehensive scoring system to quantify severity of symptoms; 15 ESC and 8 Finnegan hospitals) and their preferred primary opioid. Opioid dosing was guided by study-approved, site-specific algorithms. Infants with NOWS with a gestational age at birth of at least 36 weeks and at risk for pharmacologic treatment were enrolled between March 25, 2024, and April 9, 2025, with the last 3-month assessment on July 15, 2025. Sample size analyses were conducted between August 1, 2024, and September 23, 2024. Intervention:Sites were randomized to 1 of 2 sequences: (1) symptom-based dosing followed by scheduled opioid taper or (2) scheduled opioid taper followed by symptom-based dosing. Main Outcome and Measure:Time from birth to medical readiness for discharge. Results:Of the 626 enrolled infants (mean [SD] gestational age, 38 [1] weeks; 49% male), 383 were cared for with ESC (primary outcome cohort). The mean time to medical readiness for discharge was significantly shorter in the symptom-based dosing group compared with the scheduled opioid taper group (9.18 vs 11.61 days; adjusted mean ratio [aMR], 0.79 [95% CI, 0.65-0.96]). There was no difference in the risk for initiation of pharmacologic treatment (0.4 vs 0.41; adjusted risk ratio, 0.99 [95% CI, 0.77-1.27]) or length of stay (10.91 vs 12.09 days; aMR, 0.9 [95% CI, 0.72-1.13]) between groups. For infants in the symptom-based group, 35% (95% CI, 25%-45%) required scheduled opioid dosing due to withdrawal severity that was not controlled with intermittent dosing. In the Finnegan cohort (n = 243; planned secondary outcome), there were no significant differences in time to medical readiness for discharge (15.99 vs 17.56 days; aMR, 0.91 [95% CI, 0.72-1.15]) or length of stay (17.38 vs 19.39 days; aMR, 0.9 [95% CI, 0.69-1.16]). The inpatient composite safety outcome occurred rarely (in the ESC cohort, 3 of 188 in the symptom-based dosing vs 2 of 195 in the scheduled opioid taper groups). Conclusions and Relevance:Symptom-based dosing decreased time to medical readiness for discharge compared with a scheduled opioid taper approach among infants cared for with ESC. Trial Registration:ClinicalTrials.gov Identifier: NCT05980260.
Importance Infants with neonatal opioid withdrawal syndrome (NOWS) who receive pharmacologic treatment are traditionally treated with a scheduled opioid taper. An alternate approach, symptom-based dosing, may better align treatment with withdrawal severity. Objective To compare time from birth to medical readiness for discharge for infants with moderate to severe withdrawal treated with either a symptom-based dosing or scheduled opioid taper approach. Design, Setting, and Participants In this cluster, crossover randomized clinical trial with run-in period, 23 US hospitals cared for infants using the Eat, Sleep, Console approach (ESC) or Finnegan-based care (a comprehensive scoring system to quantify severity of symptoms; 15 ESC and 8 Finnegan hospitals) and their preferred primary opioid. Opioid dosing was guided by study-approved, site-specific algorithms. Infants with NOWS with a gestational age at birth of at least 36 weeks and at risk for pharmacologic treatment were enrolled between March 25, 2024, and April 9, 2025, with the last 3-month assessment on July 15, 2025. Sample size analyses were conducted between August 1, 2024, and September 23, 2024. Intervention Sites were randomized to 1 of 2 sequences: (1) symptom-based dosing followed by scheduled opioid taper or (2) scheduled opioid taper followed by symptom-based dosing. Main Outcome and Measure Time from birth to medical readiness for discharge. Results Of the 626 enrolled infants (mean [SD] gestational age, 38 [1] weeks; 49% male), 383 were cared for with ESC (primary outcome cohort). The mean time to medical readiness for discharge was significantly shorter in the symptom-based dosing group compared with the scheduled opioid taper group (9.18 vs 11.61 days; adjusted mean ratio [aMR], 0.79 [95% CI, 0.65-0.96]). There was no difference in the risk for initiation of pharmacologic treatment (0.4 vs 0.41; adjusted risk ratio, 0.99 [95% CI, 0.77-1.27]) or length of stay (10.91 vs 12.09 days; aMR, 0.9 [95% CI, 0.72-1.13]) between groups. For infants in the symptom-based group, 35% (95% CI, 25%-45%) required scheduled opioid dosing due to withdrawal severity that was not controlled with intermittent dosing. In the Finnegan cohort (n = 243; planned secondary outcome), there were no significant differences in time to medical readiness for discharge (15.99 vs 17.56 days; aMR, 0.91 [95% CI, 0.72-1.15]) or length of stay (17.38 vs 19.39 days; aMR, 0.9 [95% CI, 0.69-1.16]). The inpatient composite safety outcome occurred rarely (in the ESC cohort, 3 of 188 in the symptom-based dosing vs 2 of 195 in the scheduled opioid taper groups). Conclusions and Relevance Symptom-based dosing decreased time to medical readiness for discharge compared with a scheduled opioid taper approach among infants cared for with ESC. Trial Registration ClinicalTrials.gov Identifier: NCT05980260
OBJECTIVE:To determine if newborns receiving morphine or methadone as the primary pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS) tolerate and receive fewer days of opioid using an accelerated wean protocol (15% decrements) compared with using a slower wean protocol (10% decrements). STUDY DESIGN:Newborns ≥36 weeks of gestation receiving morphine or methadone for NOWS were enrolled in a pragmatic blinded, randomized multicenter trial. Newborns underwent protocol-driven weaning with decreasing opioid doses of either 15% or 10% decrements. Weaning was encouraged every 24 hours, and if signs of NOWS worsened, the preceding dose was resumed. To maintain blinding, the last 3 dose levels of the 15% decrements were placebo. The primary outcome was the number of days of opioid treatment from the first weaning dose to cessation of opioids. RESULTS:Slow enrollment prompted early trial closure; 189 newborns were randomized, 98 (51.9%) to 15% decrements (mean ± SD, 38.8 ± 1.2 weeks gestation, 59.8% male) and 91 (48.1%) to 10% decrements (38.8 ± 1.3 weeks gestation, 61.5% male). Morphine was used most commonly. Intention-to-treat analysis included all but 4 infants withdrawn in the 15% decrement group. The durations of opioid treatment during weaning were 8.2 (7.2, 9.5) (adjusted mean [95% CI]) and 11.2 (9.7, 12.9) days for 15% and 10% decrement groups, respectively (P < .001). Adverse events were few in both groups. CONCLUSION:Pharmacologic treatment of NOWS using an accelerated wean protocol (15% decrements) was well tolerated with fewer days of opioid treatment compared with 10% decrements. TRIAL REGISTRATION:ClinicalTrials.gov number: NCT04214834.
OBJECTIVES:A recent case series suggested a possible syndrome associated with prenatal fentanyl exposure. We described, among a cohort of maternal-infant dyads affected by opioid use disorder (OUD), the prevalence of these observed infant features. METHODS:We used data from MAT-LINK, a surveillance system compiling electronic health record (EHR) information from 7 US clinical sites on pregnancies affected by OUD between 2014 and 2021. We described the prevalence of EHR-documented prenatal fentanyl exposure and infant features of interest (cleft palate, corpus callosum abnormality, foot positioning deformities, genital anomalies, microcephaly, micrognathia, toe syndactyly). RESULTS:Among 5053 maternal-infant dyads affected by OUD, 667 (13.5%; 95% CI: 13.0%-14.0%) had documented prenatal fentanyl exposure, including an over 20-fold increase from 2014 to 2021. Health insurance, prenatal care timing, and nonopioid substance exposures differed between dyads with and without documented prenatal fentanyl exposure. At least one feature of interest was documented for 406 (8.0%) infants, and at least 2 were documented for 0.7%. Among infants with at least one of these features, 18.9% (95% CI: 17.1%-20.8%) had documented prenatal fentanyl exposure, compared with 13.0% (95% CI: 12.5%-13.6%) of infants without any of these features. CONCLUSIONS:In this perinatal OUD cohort, prenatal fentanyl exposure was more commonly documented among infants with at least one compared with none of these infant features. However, features were rare and contextual factors differed among dyads by prenatal fentanyl exposure status. Further analyses examining these infant features, while considering multiple exposures, are needed before substantiating a fetal fentanyl syndrome.
ObjectivesTo describe patterns of medication for opioid use disorder (MOUD) during pregnancies in the opioid use disorder (OUD) cohort of MAT-LINK, a sentinel surveillance network of pregnancies at US clinical sites.MethodsSeven clinical sites providing care for pregnant people with OUD collected electronic health record data. Pregnancies were included in this analysis if (1) the pregnancy outcome occurred between January 2014 and August 2021, (2) the person had OUD, and (3) there was any electronic health record-documented MOUD during pregnancy. Analyses describing MOUD type, demographic characteristics, and timing during pregnancy were performed.ResultsAmong 3911 pregnancies with any documented MOUD, more than 90% of pregnancies with methadone were to publicly insured people, which was greater than percentages for pregnancies with other MOUD. Buprenorphine with naloxone and naltrexone were two MOUD types that were increasingly common among pregnant people in recent years. In most pregnancies, prenatal care and MOUD were first documented in the same trimester. During the first, second, and third trimesters, there were 37%, 61%, and 91% of pregnancies with MOUD, respectively. Approximately 87% (n = 3412) had only 1 documented MOUD type, versus 2 or 3 types. However, discontinuity in MOUD across trimesters was still observed.ConclusionsIn MAT-LINK's OUD cohort, the overall frequency of MOUD improved over the course of pregnancy. Contextual factors, such as insurance status and year of pregnancy outcome, might influence MOUD type. Prenatal care and MOUD might be facilitators for one another; however, there are still opportunities to improve early linkage and continuous access to both prenatal care and MOUD during pregnancy.
Importance:The function-based eat, sleep, console (ESC) care approach substantially reduces the proportion of infants who receive pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS). This reduction has led to concerns for increased postnatal opioid exposure in infants who receive pharmacologic treatment. However, the effect of the ESC care approach on hospital outcomes for infants pharmacologically treated for NOWS is currently unknown. Objective:To evaluate differences in opioid exposure and total length of hospital stay (LOS) for pharmacologically treated infants managed with the ESC care approach vs usual care with the Finnegan tool. Design, Setting, and Participants:This post hoc subgroup analysis involved infants pharmacologically treated in ESC-NOW, a stepped-wedge cluster randomized clinical trial conducted at 26 US hospitals. Hospitals maintained pretrial practices for pharmacologic treatment, including opioid type, scheduled opioid dosing, and use of adjuvant medications. Infants were born at 36 weeks' gestation or later, had evidence of antenatal opioid exposure, and received opioid treatment for NOWS between September 2020 and March 2022. Data were analyzed from November 2022 to January 2024. Exposure:Opioid treatment for NOWS and the ESC care approach. Main Outcomes and Measures:For each outcome (total opioid exposure, peak opioid dose, time from birth to initiation of first opioid dose, length of opioid treatment, and LOS), we used generalized linear mixed models to adjust for the stepped-wedge design and maternal and infant characteristics. Results:In the ESC-NOW trial, 463 of 1305 infants were pharmacologically treated (143/603 [23.7%] in the ESC care approach group and 320/702 [45.6%] in the usual care group). Mean total opioid exposure was lower in the ESC care approach group with an absolute difference of 4.1 morphine milligram equivalents per kilogram (MME/kg) (95% CI, 1.3-7.0) when compared with usual care (4.8 MME/kg vs 8.9 MME/kg, respectively; P = .001). Mean time from birth to initiation of pharmacologic treatment was 22.4 hours (95% CI, 7.1-37.7) longer with the ESC care approach vs usual care (75.4 vs 53.0 hours, respectively; P = .002). No significant difference in mean peak opioid dose was observed between groups (ESC care approach, 0.147 MME/kg, vs usual care, 0.126 MME/kg). The mean length of treatment was 6.3 days shorter (95% CI, 3.0-9.6) in the ESC care approach group vs usual care group (11.8 vs 18.1 days, respectively; P < .001), and mean LOS was 6.2 days shorter (95% CI, 3.0-9.4) with the ESC care approach than with usual care (16.7 vs 22.9 days, respectively; P < .001). Conclusion and Relevance:When compared with usual care, the ESC care approach was associated with less opioid exposure and shorter LOS for infants pharmacologically treated for NOWS. The ESC care approach was not associated with a higher peak opioid dose, although pharmacologic treatment was typically initiated later. Trial Registration:ClinicalTrials.gov Identifier: NCT04057820.
Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence Scoring Tool, but the effects of these approaches on feeding and weight are unknown. To evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care. ESC-NOW is a cluster randomized trial of infants with NOWS born at 36 weeks’ gestation or later at 26 US hospitals from September 2020 to March 2022. Each site transitioned from usual care to ESC (the study intervention) at a randomized time. Feeding was per site practice and not specified by the intervention. Feeding and weight outcomes were assessed at hospital discharge. ESC vs usual care. Outcomes include prospectively identified secondary end points related to feeding and weight. z Scores were used for growth to account for corrected gestational age at the time of measurement. All analyses were intention to treat and adjusted for study design. Maternal/infant characteristics were included in adjusted models. The analyses included 1305 infants (702 in usual care and 603 in ESC; mean [SD] gestational age, 38.6 [1.3] weeks; 655 [50.2%] male and 650 [49.8%] female). Baseline demographic characteristics were similar between groups. The proportion of breastfed infants was higher in the ESC group (52.7% vs 41.7%; absolute difference, 11%; 95% CI, 1.0-20.9). A higher proportion of infants cared for with ESC received exclusive breast milk (15.1% vs 6.7%; absolute difference, 8.4%; 95% CI, 0.9-5.8) or any breast milk (38.8% vs 27.4%; absolute difference, 11.4%; 95% CI, 0.2-23.1) and were directly breastfeeding at discharge (35.2% vs 19.5%; absolute difference, 15.7%; 95% CI, 4.1-27.3). There was no difference in proportion of infants with weight loss greater than 10% or maximum percentage weight loss, although infants cared for with ESC had a lower weight z score on day of life 3 (−1.08 vs −1.01; absolute difference, 0.07; 95% CI, 0.02-0.12). When pharmacologic treatment was added into the model, no breastfeeding outcomes were statistically significant. In this study, infants cared for with ESC were more likely to initiate and continue breastfeeding and had no difference in percentage weight loss. The improvement in breastfeeding with ESC may be driven by reduction in pharmacologic treatment and provision of effective nonpharmacologic care. ClinicalTrials.gov Identifier: NCT04057820
ImportanceThe function-based eat, sleep, console (ESC) care approach substantially reduces the proportion of infants who receive pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS). This reduction has led to concerns for increased postnatal opioid exposure in infants who receive pharmacologic treatment. However, the effect of the ESC care approach on hospital outcomes for infants pharmacologically treated for NOWS is currently unknown.ObjectiveTo evaluate differences in opioid exposure and total length of hospital stay (LOS) for pharmacologically treated infants managed with the ESC care approach vs usual care with the Finnegan tool.Design, Setting, and ParticipantsThis post hoc subgroup analysis involved infants pharmacologically treated in ESC-NOW, a stepped-wedge cluster randomized clinical trial conducted at 26 US hospitals. Hospitals maintained pretrial practices for pharmacologic treatment, including opioid type, scheduled opioid dosing, and use of adjuvant medications. Infants were born at 36 weeks’ gestation or later, had evidence of antenatal opioid exposure, and received opioid treatment for NOWS between September 2020 and March 2022. Data were analyzed from November 2022 to January 2024.ExposureOpioid treatment for NOWS and the ESC care approach.Main Outcomes and MeasuresFor each outcome (total opioid exposure, peak opioid dose, time from birth to initiation of first opioid dose, length of opioid treatment, and LOS), we used generalized linear mixed models to adjust for the stepped-wedge design and maternal and infant characteristics.ResultsIn the ESC-NOW trial, 463 of 1305 infants were pharmacologically treated (143/603 [23.7%] in the ESC care approach group and 320/702 [45.6%] in the usual care group). Mean total opioid exposure was lower in the ESC care approach group with an absolute difference of 4.1 morphine milligram equivalents per kilogram (MME/kg) (95% CI, 1.3-7.0) when compared with usual care (4.8 MME/kg vs 8.9 MME/kg, respectively; P = .001). Mean time from birth to initiation of pharmacologic treatment was 22.4 hours (95% CI, 7.1-37.7) longer with the ESC care approach vs usual care (75.4 vs 53.0 hours, respectively; P = .002). No significant difference in mean peak opioid dose was observed between groups (ESC care approach, 0.147 MME/kg, vs usual care, 0.126 MME/kg). The mean length of treatment was 6.3 days shorter (95% CI, 3.0-9.6) in the ESC care approach group vs usual care group (11.8 vs 18.1 days, respectively; P < .001), and mean LOS was 6.2 days shorter (95% CI, 3.0-9.4) with the ESC care approach than with usual care (16.7 vs 22.9 days, respectively; P < .001).Conclusion and RelevanceWhen compared with usual care, the ESC care approach was associated with less opioid exposure and shorter LOS for infants pharmacologically treated for NOWS. The ESC care approach was not associated with a higher peak opioid dose, although pharmacologic treatment was typically initiated later.Trial RegistrationClinicalTrials.gov Identifier: NCT04057820
INTRODUCTION:As perinatal drug overdoses continue to rise, reliable approaches are needed to monitor overdose trends during pregnancy and postpartum. This analysis aimed to determine the sensitivity, specificity, positive predictive value, and negative predictive value of ICD-9/10-CM codes for drug overdose events among people in the MATernaL and Infant clinical NetworK (MAT-LINK) with medication for opioid use disorder during pregnancy. METHODS:People included in this analysis had electronic health record documentation of medication for opioid use disorder and a known pregnancy outcome from January 1, 2014, through August 31, 2021. Data were analyzed during pregnancy through 1 year postpartum. The Centers for Disease Control and Prevention's drug overdose case definitions were used to categorize overdose based on ICD-9/10-CM codes. These codes were compared to abstracted electronic health record data of any drug overdose. Analyses were conducted between May 2023 and May 2024. RESULTS:Among 3,911 pregnancies with electronic health record-documented medication for opioid use disorder, the sensitivity of ICD-9/10-CM codes for capturing drug overdose during pregnancy was 32.7%, while specificity was 98.5%, positive predictive value was 23.4%, and negative predictive value was 99.0%. The sensitivity of ICD-9/10-CM codes for capturing drug overdose postpartum was 30.9%, while specificity was 98.4%, positive predictive value was 25.9%, and negative predictive value was 98.8%. CONCLUSIONS:The sensitivity and positive predictive value of ICD-9/10-CM codes for capturing drug overdose compared with abstracted electronic health record data during the perinatal period was low in this cohort of people with medication for opioid use disorder during pregnancy, though the specificity and negative predictive value were high. Incorporating other data from electronic health records and outside the healthcare system might provide more comprehensive insights on nonfatal drug overdose in this population.
Importance:Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence Scoring Tool, but the effects of these approaches on feeding and weight are unknown. Objective:To evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care. Design, Setting, and Participants:ESC-NOW is a cluster randomized trial of infants with NOWS born at 36 weeks' gestation or later at 26 US hospitals from September 2020 to March 2022. Each site transitioned from usual care to ESC (the study intervention) at a randomized time. Feeding was per site practice and not specified by the intervention. Feeding and weight outcomes were assessed at hospital discharge. Intervention:ESC vs usual care. Main Outcomes and Measures:Outcomes include prospectively identified secondary end points related to feeding and weight. z Scores were used for growth to account for corrected gestational age at the time of measurement. All analyses were intention to treat and adjusted for study design. Maternal/infant characteristics were included in adjusted models. Results:The analyses included 1305 infants (702 in usual care and 603 in ESC; mean [SD] gestational age, 38.6 [1.3] weeks; 655 [50.2%] male and 650 [49.8%] female). Baseline demographic characteristics were similar between groups. The proportion of breastfed infants was higher in the ESC group (52.7% vs 41.7%; absolute difference, 11%; 95% CI, 1.0-20.9). A higher proportion of infants cared for with ESC received exclusive breast milk (15.1% vs 6.7%; absolute difference, 8.4%; 95% CI, 0.9-5.8) or any breast milk (38.8% vs 27.4%; absolute difference, 11.4%; 95% CI, 0.2-23.1) and were directly breastfeeding at discharge (35.2% vs 19.5%; absolute difference, 15.7%; 95% CI, 4.1-27.3). There was no difference in proportion of infants with weight loss greater than 10% or maximum percentage weight loss, although infants cared for with ESC had a lower weight z score on day of life 3 (-1.08 vs -1.01; absolute difference, 0.07; 95% CI, 0.02-0.12). When pharmacologic treatment was added into the model, no breastfeeding outcomes were statistically significant. Conclusions and Relevance:In this study, infants cared for with ESC were more likely to initiate and continue breastfeeding and had no difference in percentage weight loss. The improvement in breastfeeding with ESC may be driven by reduction in pharmacologic treatment and provision of effective nonpharmacologic care. Trial Registration:ClinicalTrials.gov Identifier: NCT04057820.
Objectives:This study aimed to develop and validate an algorithm for the identification of opioid use disorder (OUD) in pregnant patients using electronic medical record (EMR) data. Materials and Methods:A cohort of pregnant patients from a single institution was used to develop and validate the algorithm. Five algorithm components were used, and chart reviews were conducted to confirm OUD diagnoses based on established criteria. Positive predictive values (PPV) of each of the algorithm's components were assessed. Results:Of the 334 charts identified by the algorithm, 256 true cases were confirmed. The overall PPV of the algorithm was 76.6%, with 100% accuracy for outpatient medication lists, and high PPVs ranging from 81.3% to 93.4% across other algorithm components. Discussion and Conclusion:The study highlights the significance of a multifaceted approach in identifying OUD among pregnant patients, aiming to improve patient care and target interventions for patients at risk.
BACKGROUND:Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown. METHODS:In this cluster-randomized, controlled trial at 26 U.S. hospitals, we enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks' gestation or more. At a randomly assigned time, hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach. During a 3-month transition period, staff members at each hospital were trained to use the new approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. Composite safety outcomes that were assessed during the first 3 months of postnatal age included in-hospital safety, unscheduled health care visits, and nonaccidental trauma or death. RESULTS:A total of 1305 infants were enrolled. In an intention-to-treat analysis that included 837 infants who met the trial definition for medical readiness for discharge, the number of days from birth until readiness for hospital discharge was 8.2 in the Eat, Sleep, Console group and 14.9 in the usual-care group (adjusted mean difference, 6.7 days; 95% confidence interval [CI], 4.7 to 8.8), for a rate ratio of 0.55 (95% CI, 0.46 to 0.65; P<0.001). The incidence of adverse outcomes was similar in the two groups. CONCLUSIONS:As compared with usual care, use of the Eat, Sleep, Console care approach significantly decreased the number of days until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes. (Funded by the Helping End Addiction Long-term (HEAL) Initiative of the National Institutes of Health; ESC-NOW ClinicalTrials.gov number, NCT04057820.).
Problem: Medication for opioid use disorder (MOUD) is recommended for persons with opioid use disorder (OUD) during pregnancy. However, knowledge gaps exist about best practices for management of OUD during pregnancy and these data are needed to guide clinical care. Period Covered: 2014-2021. Description of the System: Established in 2019, the Maternal and Infant Network to Understand Outcomes Associated with Medication for Opioid Use Disorder During Pregnancy (MAT-LINK) is a surveillance network of seven clinical sites in the United States. Boston Medical Center, Kaiser Permanente Northwest, The Ohio State University, and the University of Utah were the initial clinical sites in 2019. In 2021, three clinical sites were added to the network (the University of New Mexico, the University of Rochester, and the University of South Florida). Persons receiving care at the seven clinical sites are diverse in terms of geography, urbanicity, race and ethnicity, insurance coverage, and type of MOUD received. The goal of MAT-LINK is to capture demographic and clinical information about persons with OUD during pregnancy to better understand the effect of MOUD on outcomes and, ultimately, provide information for clinical care and public health interventions for this population. MAT-LINK maintains strict confidentiality through robust information technology architecture. MAT-LINK surveillance methods, population characteristics, and evaluation findings are described in this inaugural surveillance report. This report is the first to describe the system, presenting detailed information on funding, structure, data elements, and methods as well as findings from a surveillance evaluation. The findings presented in this report are limited to selected demographic characteristics of pregnant persons overall and by MOUD treatment status. Clinical and outcome data are not included because data collection and cleaning have not been completed; initial analyses of clinical and outcome data will begin in 2023. Results: The MAT-LINK surveillance network gathered data on 5,541 reported pregnancies with a known pregnancy outcome during 2014-2021 among persons with OUD from seven clinical sites. The mean maternal age was 29.7 (SD = +/- 5.1) years. By race and ethnicity, 86.3% of pregnant persons were identified as White, 25.4% as Hispanic or Latino, and 5.8% as Black or African American. Among pregnant persons, 81.6% had public insurance, and 84.4% lived in urban areas. Compared with persons not receiving MOUD during pregnancy, those receiving MOUD during pregnancy were more likely to be older and White and to have public insurance. The evaluation of the surveillance system found that the initial four clinical sites were not representative of demographics of the South or Southwest regions of the United States and had low representation from certain racial and ethnic groups compared with the overall U.S. population; however, the addition of three clinical sites in 2021 made the surveillance network more representative. Automated extraction and processing improved the speed of data collection and analysis. The ability to add new clinical sites and variables demonstrated the flexibility of MAT-LINK. Interpretation: MAT-LINK is the first surveillance system to collect comprehensive, longitudinal data on pregnant person-infant dyads with perinatal outcomes associated with MOUD during pregnancy from multiple clinical sites. Analyses of clinical site data demonstrated different sociodemographic characteristics between the MOUD and non-MOUD treatment groups. Public Health Actions: MAT-LINK is a timely and flexible surveillance system with data on approximately 5,500 pregnancies. Ongoing data collection and analyses of these data will provide information to support clinical and public health guidance to improve health outcomes among pregnant persons with OUD and their children.