Clinical trial NCT06915259: Doula Model of Care
Official title: Doula Model of Care, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal
Morbidity
Mental Health
Keywords: Doula
community models of care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: March of Dimes
First posted: 2025-04-08
Enrollment: 230
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Edinburgh Postpartum Depression Scale (EPDS) score
timeFrame: After delivery up to 6 weeks postpartum
Secondary outcomes:
measure: Obstetric outcomes: Mode of delivery
timeFrame: At delivery
measure: Obstetric outcomes: Preterm birth less than 37 weeks
timeFrame: At delivery
measure: Obstetric outcomes: Preterm birth less than 34 weeks
timeFrame: At delivery
measure: Self-efficacy
timeFrame: Post-randomization to 6 weeks postpartum
measure: Person centered prenatal care survey for people of color
timeFrame: After delivery up to 6 weeks postpartum
measure: Birth satisfaction (BSS-R survey)
timeFrame: After delivery up to 6 weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sindhu K Srinivas, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: