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Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

RecruitingNAAges 18 Years - 65 YearsFemaleMedical College of Wisconsin
NCT05993689 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sustai

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📋 Eligibility rules (as published)
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
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What it tests

  • BUNDLE
  • Usual Care
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Where

1 site
Medical College of Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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