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Understanding the Role of Doulas in Supporting People With PMADs

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from University of Montana

Record History

  1. Primary and study completion pushed from Jul 31, 2026 to Dec 31, 2026
    • Site contact updated
    v7
  2. Primary completion date: Jan 30, 2026 to Jul 31, 2026
    • Study completion date: Dec 28, 2026 to Jul 31, 2026
    • Site contact updated
    v6
  3. Start date: Sep 1, 2024 to Nov 26, 2024
    • Primary completion date: Dec 30, 2025 to Jan 30, 2026
    • Study completion date: Feb 28, 2026 to Dec 28, 2026
    • Site contact updated
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 31, 2025 to Dec 30, 2025
    • Study completion date: Aug 31, 2025 to Feb 28, 2026
    v4
  5. Primary and study completion dates: Feb 2025 to Aug 31, 2025
    • Start date: Jul 1, 2024 to Sep 1, 2024
    v3
  6. Start date: Mar 1, 2024 to Jul 1, 2024v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.
Trial Details
NCT Number NCT05763537
Lead Sponsor University of Montana
Conditions
(from sponsor)		 Maternal Health, Pregnancy, Delivery, Obstetric, Self Efficacy, Social Support, Mental Health, Substance-Related Disorders, Postpartum Depression +2 more
Related terms Depression, Depression, Postpartum, Psychological Well-Being, Substance-Related Disorders
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov