Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

NCT05993689 | Recruiting

• 1 other identifier: PRO00047801
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Perinatal Healthcare Engagement

  A composite of the following variables to assess perinatal healthcare engagement: 1) Attended at least \~75% of the recommended prenatal visits; 2) Attended postpartum visit; 3) Received recommended vaccination during pregnancy.

  From study enrollment and until 12 months postpartum

Secondary Outcomes (9)

• Trust in Provider

  Baseline; third trimester, and postpartum

• Reported Discrimination

  Baseline, third trimester and postpartum

• Perceived Stress

  Baseline, third trimester and postpartum

• Depression

  Baseline, third trimester and postpartum

• Cesarean birth

  At study completion

Study Arms (2)

BUNDLE Intervention

EXPERIMENTAL

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.

Other: BUNDLE

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

BUNDLE OTHER

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

BUNDLE Intervention

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3522, United States

RECRUITING

Central Study Contacts

Anna Palatnik, MD

CONTACT

(414) 805-6624; apalatnik@mcw.edu

Joni S Williams, MD, MPH

CONTACT

(414) 955-8827; jswilliams@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: August 15, 2023
• Study Start: January 2, 2025
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 30, 2025

Record last verified: 2025-03

Locations

US (1)