Recruiting

Bundle

Sponsor:

Medical College of Wisconsin

Code:

NCT05993689

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BUNDLE

Usual Care

Study Details

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

Study ID

NCT05993689

Start date

Jan 2, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

412 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

BUNDLE

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

Usual Care

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anna Palatnik, MD

(414) 805-6624apalatnik@mcw.edu

Joni S Williams, MD, MPH

(414) 955-8827jswilliams@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3522

Contacts

Erica Marion, PhD

4148058505emarion@mcw.edu

Alyssa Hernandez, DO

4148055285alyhernandez@mcw.edu

Principal Investigator:

Anna Palatnik, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-20.