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RECRUITING Not applicable ClinicalTrials.gov

Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

Sponsor: University of Arkansas • ClinicalTrials.gov ID: NCT07071766

Registry updated: 2026-09-09
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Description

Drug overdose is a leading cause of death among postpartum women and opioid-related mortality is 4 times higher in the postpartum period when compared to the third trimester of pregnancy. Medications for opioid use disorder (MOUD; e.g., methadone or buprenorphine) are the recommended standard of care for perinatal women with OUD. Studies indicate that 50-60% of perinatal women with OUD initiate medications during pregnancy; however, over half will prematurely discontinue treatment within the first six months of childbirth due to stressors experienced in the postpartum period. Common stressors that contribute to MOUD treatment discontinuation in this population are return to opioid use, mental health symptoms including depression, parenting-related stressors such as challenges in infant care and bonding, Neonatal Abstinence Syndrome (NAS), child welfare involvement, and feelings of guilt, shame, and stigma. Thus, there is an urgent need to develop effective, recovery-oriented support interventions that promote the initiation and continuity of MOUD treatment in the postpartum period. The current study utilizes community-engaged research methods to identify and prioritize the early parenting-related needs of postpartum women receiving MOUD to inform the adaptation and implementation of an evidence-based parenting intervention for this population receiving outpatient treatment for opioid use disorder.

Interventions

  • Proud of Baby and Me (Behavioral)
    The original Baby \& Me curricula was adapted to be delivered in outpatient substance use treatment settings to newly postpartum women receiving medications for opioid use disorder (MOUD) for this study.

Eligibility criteria

Inclusion Criteria: * 18 years or older * Understand and speak English * Able to give informed consent * Receiving medications for opioid use disorder in the outpatient clinical setting * Between 28 weeks gestation and up to 12 months postpartum Exclusion Criteria: * Unwilling to consent * Before 28 weeks gestation and beyond 12 months postpartum at enrollment

Conditions

Substance Use Treatment Perinatal Substance Use Parenting

Locations

  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record