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Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Who can join

Ages 18 to 65 · Women

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

About the study

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.

What is being tested

• BUNDLE (other)
• Usual Care (other)

Sponsor: Medical College of Wisconsin · Participants: 412 · Started: Jan 2, 2025

Contact the study team

• Anna Palatnik, MD · Phone: (414) 805-6624
• Joni S Williams, MD, MPH · Phone: (414) 955-8827

Official record on ClinicalTrials.gov — NCT05993689

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.