Doula Model of Care

NCT06915259 | Active Not Recruiting

• 1 other identifier: 857762
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perinatal; Morbidity; Mental Health

Keywords

Doula; community models of care

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postpartum Depression Scale (EPDS) score

  Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen

  After delivery up to 6 weeks postpartum

Secondary Outcomes (6)

• Obstetric outcomes: Mode of delivery

  At delivery

• Obstetric outcomes: Preterm birth less than 37 weeks

  At delivery

• Obstetric outcomes: Preterm birth less than 34 weeks

  At delivery

• Self-efficacy

  Post-randomization to 6 weeks postpartum

• Person centered prenatal care survey for people of color

  After delivery up to 6 weeks postpartum

Study Arms (2)

Usual Care

NO INTERVENTION

Participants will continue to receive prenatal, labor and delivery, and postpartum care as they normally would if not in the study. Patients who seek doula services on their own will be allowed to do so

Doula Model of Care

EXPERIMENTAL

Participants will be offered to receive services by the certified doula. The doula will provide emotional support, prenatal support, intrapartum support and will facilitate the receipt of postpartum health care for the patient.

Other: Doula Model of Care

Interventions

Doula Model of Care OTHER

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.

Doula Model of Care

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• March of Dimes: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Sindhu K Srinivas, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Hospital of the University of Pennsylvania Cedar Avenue

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 8, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)