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Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of Jul 1, 2026 to Sep 1, 2026v7
  2. Notable Primary completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Start date: Apr 1, 2026 to Jul 1, 2026
    v6
  3. Notable Recruitment opened
    • Start date: Mar 1, 2026 to Apr 1, 2026
    • Site details revised
    v5
  4. Notable Start date: Jan 1, 2026 to Mar 1, 2026v4
  5. Notable Start date: Oct 1, 2025 to Jan 1, 2026v3
  6. Notable Start date: Aug 1, 2025 to Oct 1, 2025v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07071766
Lead Sponsor University of Arkansas
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)
Substance Use Treatment, Perinatal Substance Use, Parenting
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov