Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05993689
Status
Recruiting
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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • BUNDLE — OTHER
    An integrated model of community-based doulas and clinical obstetric providers
  • Usual Care — OTHER
    Standard of care for pregnancy and pregnancy-related issues by the obstetric provider

Study Details

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.

Key Dates

Start date
Jan 2, 2025
Status verified
Mar 2025
Primary completion
Nov 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
412 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: BUNDLE 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.
  • Active Comparator: Usual Care
    Standard of care for pregnancy and pregnancy-related issues will be provided by the obstetric provider as per routine.

Primary Outcome Measure

Perinatal Healthcare Engagement [ Time Frame: From study enrollment and until 12 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226-3522
Erica Marion, PhD
[email protected]
4148058505
Alyssa Hernandez, DO
[email protected]
4148055285
Anna Palatnik, MD (PRINCIPAL_INVESTIGATOR)

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