Integrating community doulas into prenatal care for Black mothers
Official title: Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
Run by Medical College of Wisconsin · NCT05993689 · Data updated 2026-11-12
This study is testing if adding community doulas to prenatal care can help Black mothers have better experiences and health outcomes during pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 412 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | November 30, 2029 |
| Study ends | June 30, 2030 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT05993689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are Black or African American pregnant individuals with a singleton gestation who are receiving care at the Froedtert & Medical College of Wisconsin Health System.
✕Probably not a fit
Patients planning to deliver outside of the Froedtert & Medical College of Wisconsin Health System or those receiving additional support beyond routine prenatal care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The BUNDLE study aims to enhance prenatal care by integrating community doulas with obstetricians to improve trust and maternal health outcomes among Black and African American birthing individuals. It consists of three phases: first, focus groups will gather insights from pregnant individuals and healthcare providers on effective integration strategies. Next, a randomized controlled trial will assess the effectiveness of this integrated model compared to standard prenatal care. Finally, the findings will be disseminated to healthcare leaders and policymakers to advocate for doula coverage and sustainable health systems.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal health outcomes and greater trust in prenatal care among Black and African American communities.
How similar studies have gone: Other studies have shown promise in integrating community health workers into prenatal care, suggesting that this approach could be beneficial, though the specific integration of doulas in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Anna Palatnik, MD
- Email: apalatnik@mcw.edu
- Phone: (414) 805-6624
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.