BUNDLE Study: Doula Partnership for Black/African American Pregnant Individuals

The BUNDLE study is looking at a new way to combine care from community doulas and regular obstetric (pregnancy) doctors for Black/African American pregnant individuals. This study aims to build trust and improve health outcomes for mothers. You could be eligible if you are a Black or African American woman, 18-65 years old, pregnant with one baby, and receive your OBGYN care at Froedtert & the Medical College of Wisconsin (F&MCW) Health System. The study will compare this new combined care model (BUNDLE) to standard pregnancy care (Usual Care). Success will be measured by how much you engage with your healthcare, from when you join the study until 12 months after your baby is born. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 412 participants. It will compare an integrated model of community-based doulas and clinical obstetric providers (BUNDLE) to standard care (Usual Care).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from study enrollment until 12 months postpartum.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05993689

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Recruiting
NAAges 18–65InterventionalSupportive care
Medical College of Wisconsin
~412 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:BUNDLEUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perinatal Healthcare Engagement
Measured over From study enrollment and until 12 months postpartum
Pregnancy Related
1 sites across 1 states
Wisconsin1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • Perinatal Healthcare EngagementFrom study enrollment and until 12 months postpartum

    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.