About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BUNDLE
- Usual Care