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Understanding the Role of Doulas in Supporting People With PMADs
NCT05763537 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Standard Doula Care Plus PMAD Intervention
- BEHAVIORAL Standard Doula Care
Study Locations (1)
Montana
- University of Montana — Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05763537
The ClinicalTrials.gov registry entry for NCT05763537 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Montana, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions — of which Standard Doula Care Plus PMAD Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05763537 reports 1 study location spanning 1 distinct geographic area — top geographies include Montana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05763537 about?
NCT05763537 is a clinical study titled "Understanding the Role of Doulas in Supporting People With PMADs". 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 t...
What is the current status of trial NCT05763537?
This trial is currently recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2024-11-26. Estimated completion is 2026-07-31.
What conditions does trial NCT05763537 study?
This clinical trial studies the following conditions: Depression, Pregnancy, Mental Health, Substance-Related Disorders, Postpartum Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05763537?
The interventions under investigation include: Standard Doula Care Plus PMAD Intervention (BEHAVIORAL), Standard Doula Care (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05763537?
This trial is sponsored by University of Montana, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05763537 being conducted?
This trial has 1 study location across Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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