NCT05763537 Understanding the Role of Doulas in Supporting People With PMADs
| NCT ID | NCT05763537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Montana |
| Condition | Maternal Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-07-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Participants must be over the age of 18 * Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment * Live in a HRSA-designated rural area of Montana Exclusion Criteria: * They are under the age of 18 * Not currently pregnant * Not between 13-26 gestational weeks at the time of enrollment * If they do not live in a HRSA-designated rural are of Montana.