Doula Model of Care

NCT ID: NCT06915259

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2026-03-31

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.

Detailed Description

Integrated bi-directional partnerships between birthing facilities, health care providers and community leaders and community birth support persons, such as doulas, is critical to improving health equity and maternal outcomes. This study is partnering with a birth worker/community support organization, with a mission to celebrate Black motherhood and influence favorable outcomes in Black Maternal Health by promoting a community-empowered model of care.

The United States has one of the largest racial and ethnic disparities in pregnancy-related morbidity and mortality of industrialized nations. Black, Indigenous and other people of color (BIPOC) patients have a 2-3 times higher risk of pregnancy-related mortality compared to white patients. For every maternal death, over 100 patients experience a severe maternal morbidity, which is a life-threatening complication during their delivery hospitalization, resulting in over 50,000 women and birthing people experiencing one of these events every year in the U.S. (with the majority occurring in BIPOC patients). These disparities are even more pronounced in the city of Philadelphia, the poorest of the nation's top ten largest cities. A recent report from the Philadelphia Maternal Mortality Review Committee identified 80% of mortalities were among BIPOC patients and 80% of those mortalities had identified social and structural barriers, including, but not limited to, mental health issues, substance use disorders and lack of prenatal care. Integrated bi-directional partnerships between birthing facilities, health care providers and community leaders and community birth support persons, such as doulas, is critical to improving health equity and maternal outcomes. While doulas and other community organizations partner with some birthing providers, the way in which this occurs is variable and the most effective model for integration through the pregnancy continuum has not been determined. Results from previous studies show the importance of implementing community models of care throughout the pregnancy continuum that will mitigate bias, mistrust, and mistreatment thereby improving both the experience and outcomes specifically and especially for Black birthing people.

The study will test the hypothesis that 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 at HUP. Within this study, the investigators will determine the effectiveness of this integrated partnership in reducing maternal depression score at 6 weeks postpartum. Self-efficacy, perceived trust of care providers, stress, birth satisfaction, and obstetric outcomes will also be assessed. Patients will be randomized (n=230) 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Doula Model of Care

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.

Group Type: EXPERIMENTAL

Doula Model of Care

Intervention Type: 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.

Interventions

Doula 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

March of Dimes

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Sindhu Srinivas, MD

Executive Director, Hospital of the University of Pennsylvania Cedar Avenue

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sindhu K Srinivas, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sindhu K Srinivas, MD, MSCE

Role: CONTACT

ssrinivas@pennmedicine.upenn.edu

215-662-2982

Elizabeth Norton, MPH

Role: CONTACT

elizabeth.norton@pennmedicine.upenn.edu

Facility Contacts

Elizabeth Norton, MPH, MBE

Role: primary

elizabeth.norton@pennmedicine.upenn.edu

215-349-5277

Meaghan McCabe, MPH

Role: backup

meaghan.mccabe@pennmedicine.upenn.edu

215-349-5277

Other Identifiers

857762

Identifier Type: -

Identifier Source: org_study_id