Doula Model of Care
Running, not enrolling · Not applicable
Conditions studied: Perinatal, Morbidity, Mental Health
In brief
The goal of this randomized controlled intervention trial is to determine if an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP), will improve both the experience and outcomes for Black birthing people. The main question it aims to answer is whether an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP) will mitigate bias and mistrust thereby improving both the experience and outcomes for Black birthing people, assessed by the primary outcome of depression score. Participants will be randomized to Doula care (receive 2 prenatal visits, continuous intrapartum support, and 2 postpartum visits with a certified doula) or standard of care (receive prenatal care, labor and delivery, and postpartum care as they normally would if not in the study) and followed through 6 weeks postpartum.
Key facts
- Study ID
- NCT06915259
- Run by
- University of Pennsylvania
- People needed
- 230
- Starts
- 2025-04-16
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 16 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant patients who self-identify (as seen on Chart) as Black
- Ages 16-55
- Currently pregnant and in second trimester (gestational age between 13-30 weeks)
- Plan to deliver at HUP
- Patients must be able to read and understand English
- Participants must be willing and able to sign the informed consent form
You may not qualify if…
- Unable to provide written consent by being unable to read or sign informed consent.
- PI Discretion
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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