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RECRUITING
NCT05993689
NA

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2025-01-02

Completion Date

2030-06-30

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

OTHER

BUNDLE

An integrated model of community-based doulas and clinical obstetric providers

OTHER

Usual Care

Standard of care for pregnancy and pregnancy-related issues by the obstetric provider

Locations (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States