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Recruiting
NCT05993689
Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Conditions: Pregnancy Related
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 412
Sponsor: Medical College of Wisconsin
Location: Medical College of Wisconsin Milwaukee Wisconsin
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
Source: ClinicalTrials.gov (NCT05993689). StuddyBuddy aggregates publicly available trial information.