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Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

NCT05993689 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Pregnancy Related

Interventions

OTHER

BUNDLE

An integrated model of community-based doulas and clinical obstetric providers

OTHER

Usual Care

Standard of care for pregnancy and pregnancy-related issues by the obstetric provider

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2029-11-30
Completion
2030-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05993689 on ClinicalTrials.gov