Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Recruiting now · Not applicable

Conditions studied: Pregnancy Related

In brief

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 facts

Study ID

NCT05993689

Run by

Medical College of Wisconsin

People needed

412

Starts

2025-01-02

Expected to finish

2030-06-30

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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