NCT05993689 Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
| NCT ID | NCT05993689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 412 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2029-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 412 participants in total. It began in 2025-01-02 with a primary completion date of 2029-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Self-reported Black or African American * Pregnant with singleton gestation * Has an established OBGY at Froedtert \& the Medical College of Wisconsin (F\&MCW) Health System Exclusion Criteria: * Planning to deliver outside of F\&MCW Health System * Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula * Inability or unwillingness to provide informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05993689 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05993689 currently recruiting?
Yes, NCT05993689 is actively recruiting participants. Contact the research team at apalatnik@mcw.edu for enrollment information.
Where is the NCT05993689 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT05993689 clinical trial?
NCT05993689 is sponsored by Medical College of Wisconsin. The trial plans to enroll 412 participants.