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PerinatalNCT06915259

Doula Model of Care

A study testing Doula Model of Care in people with Perinatal and Morbidity, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Perinatal, Morbidity, Mental Health
What is being tested?
Doula Model of Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteUnited States
Study dates
16 Apr 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Doula Model of Care, A Randomized Controlled Trial

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.

Read the 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.

Being tested
Doula Model of Care
Keywords
Doula, community models of care
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doula Model of CareOther

    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.

Study groups in NCT06915259
Study groupRoleWhat they receive
Usual CareNo interventionParticipants 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 CareExperimentalParticipants 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.
Receives: Other: Doula Model of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: After delivery up to 6 weeks postpartum

Secondary outcomes (6)
  1. Obstetric outcomes: Mode of delivery

    Vaginal or cesarean

    Measured: At delivery

  2. Obstetric outcomes: Preterm birth less than 37 weeks

    Preterm delivery defined as less than 37 weeks

    Measured: At delivery

  3. Obstetric outcomes: Preterm birth less than 34 weeks

    Preterm delivery defined as less than 34 weeks.

    Measured: At delivery

  4. Self-efficacy

    Self efficacy assessed by the PROMIS General Self-efficacy scale, 10-item scale assessing confidence in ability to deal effectively with a variety of stressful situations. Survey to be completed at randomization and at 6 weeks post partum. The PROMIS General Self-Efficacy measure uses a T-score system, where 50 represents the average for the general population and a standard deviation of 10. A higher T-score indicates greater self-efficacy.

    Measured: Post-randomization to 6 weeks postpartum

  5. Person centered prenatal care survey for people of color

    Scores from this 34-item scale will be calculated using standard scoring criteria. This scale measures person-centered prenatal care that reflects the experiences of people of color. Scores range from 0 to 100, where higher scores indicate more person-centered prenatal care

    Measured: After delivery up to 6 weeks postpartum

  6. Birth satisfaction (BSS-R survey)

    Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction

    Measured: After delivery up to 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start16 Apr 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915259
Sponsor's protocol ID
857762
Status last verified
Apr 2026
First submitted
27 Mar 2025
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Doula Model of Care in people with Perinatal and Morbidity, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Edinburgh Postpartum Depression Scale (EPDS) score (time frame: After delivery up to 6 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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