Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Public ClinicalTrials.gov record NCT05993689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05993689
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 412 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2025
- Primary completion
- Nov 29, 2029
- Completion
- Jun 29, 2030
- Last update posted
- Jul 19, 2026
2025 – 2030
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3522 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05993689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2026 · Synced Jul 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05993689 live on ClinicalTrials.gov.