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Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

NCT07071766 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Substance Use Treatment
  • Perinatal Substance Use
  • Parenting

Interventions

BEHAVIORAL

Proud of Baby and Me

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.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Mollee K Steely Smith, PhD · University of Arkansas

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071766 on ClinicalTrials.gov