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NCT05993689 · ClinicalTrials.gov registry record · NA
Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
A NA study of Pregnancy Related, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- NA
- Development phase
- 412
- Enrollment target
- 1
- Study location
NCT05993689: Recruiting NA study of Pregnancy Related, sponsored by Medical College of Wisconsin.
NCT05993689 is a NA study of Pregnancy Related that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 412 participants, below the 1,959-participant average among 99 other Pregnancy Related trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05993689, a NA study of Pregnancy Related, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- NA
- Development phase
- 412 participants
- Enrollment target
- 1
- Study location
Study Summary
The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.
Primary Outcome
A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least \~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.
Conditions Studied
Interventions
- OTHER Usual Care
- OTHER BUNDLE
Study Locations (1)
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2025-01-02 |
| Est. Completion | 2030-06-30 |
| Phase | NA |
What NCT05993689 shows while recruiting
NCT05993689 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, below the 1,959-participant average among 99 other Pregnancy Related trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT05993689 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05993689 about?
NCT05993689 is a clinical study titled "Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE". The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community ...
What is the current status of trial NCT05993689?
This trial is currently recruiting. It is a NA study. The enrollment target is 412 participants. The study started on 2025-01-02. Estimated completion is 2030-06-30.
What conditions does trial NCT05993689 study?
This clinical trial studies the following conditions: Pregnancy Related.
What interventions are being tested in trial NCT05993689?
The interventions under investigation include: Usual Care (OTHER), BUNDLE (OTHER).
Who is sponsoring clinical trial NCT05993689?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05993689 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05993689's enrollment target sits among peer trials
412 34th of 99 higher than 66 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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