Doula Partnership for Pregnancy

(BUNDLE Trial)

Overseen By Joni S Williams, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-Froedtert delivery, Group care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

412 Participants Needed

Trial Summary

What is the purpose of 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

The BUNDLE study is for Black or African American individuals who are pregnant with one baby and already have an OB-GYN at Froedtert & the Medical College of Wisconsin Health System. It aims to improve trust and maternal health outcomes.

Inclusion Criteria

You have identified yourself as Black or African American.

You are pregnant with a single fetus.

You have a registered OBGYN at the Froedtert & Medical College of Wisconsin Health System.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Phase

Conducting focus groups with Black/African American birthing people and healthcare providers to integrate community-based doulas and obstetricians into prenatal care

Not specified

6 focus groups

Randomized Controlled Trial

Testing the effectiveness of the integrated prenatal care model on healthcare engagement, trust, and adverse maternal outcomes

From study enrollment until 12 months postpartum

Multiple visits throughout pregnancy and postpartum

Dissemination

Disseminating findings in scholarly and community-based forums and advocating for policy changes

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months postpartum

Treatment Details

Interventions

• BUNDLE

Trial Overview This study tests a new model that integrates community-based doulas into prenatal care. Participants will either receive usual care or be part of the BUNDLE intervention, which includes doula support, to see if it improves healthcare engagement and reduces adverse outcomes.

Participant Groups

Group I: BUNDLE Intervention Experimental Treatment 1 Intervention

Proposed components of the intervention will include: 1) attendance at two visits in the 2nd trimester and two visits in the 3rd trimester by a doula; 2) exchange of contact information between the clinic and the doula; 3) exchange of social needs and social-structural risk factors complicating patient's prenatal care from doula and exchange of clinical risk factors complicating prenatal care from obstetric provider; 4) communication between the doula and provider; 5) educating the obstetric team on benefits of doula support; 6) preparing labor and delivery team for presence of doula during labor ; and 7) enhancing doula support postpartum for cardiovascular risk reduction.

Group II: Usual Care Active Control 1 Intervention

Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+