Doula Model of Care

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.

NCT Number	NCT06915259
Lead Sponsor	University of Pennsylvania Collaborators: March of Dimes
Conditions	Perinatal, Morbidity, Mental Health
Enrollment	230 participants
Start Date	2025-04-16
Primary Completion	2026-11 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-04-22