← Back to Clinical Trials
Recruiting NCT05993689

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Trial Parameters

Condition Pregnancy Related
Sponsor Medical College of Wisconsin
Study Type INTERVENTIONAL
Phase N/A
Enrollment 412
Sex FEMALE
Min Age 18 Years
Max Age 65 Years
Start Date 2025-01-02
Completion 2029-11-30
Interventions
BUNDLEUsual Care

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

Related Trials