Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorMedical College of Wisconsin

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

Treatment groups

412 Participants
are divided into 2 treatment groups

Sponsors and collaborators