RecruitingNot ApplicableNCT06915259

Doula Model of Care

Doula Model of Care, A Randomized Controlled Trial


Sponsor

University of Pennsylvania

Enrollment

230 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 55 Years

Inclusion Criteria6

  • 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

Exclusion Criteria2

  • Unable to provide written consent by being unable to read or sign informed consent.
  • PI Discretion

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Interventions

OTHERDoula Model of Care

Doula model of care is defined as emotional support, prenatal support, intrapartum support, and postpartum support provided to the birthing individual by a certified doula.


Locations(1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06915259


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