RecruitingNot ApplicableNCT05993689

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE


Sponsor

Medical College of Wisconsin

Enrollment

412 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BUNDLE and Usual Care for people with pregnancy related. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERBUNDLE

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

OTHERUsual Care

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


Locations(1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05993689


Related Trials