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.
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
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.
- Conditions
- Perinatal, Morbidity, Mental Health
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Doula Model of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Obstetric outcomes: Mode of delivery
Vaginal or cesarean
Measured: At delivery
Obstetric outcomes: Preterm birth less than 37 weeks
Preterm delivery defined as less than 37 weeks
Measured: At delivery
Obstetric outcomes: Preterm birth less than 34 weeks
Preterm delivery defined as less than 34 weeks.
Measured: At delivery
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
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
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.
- First posted8 Apr 2025
- Study start16 Apr 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerinatalStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- March of Dimes
- Responsible party
- Principal investigator, Sindhu Srinivas, MD, University of Pennsylvania
- Investigators
- Sindhu K Srinivas, MD, MSCE, Principal investigator, University of Pennsylvania
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doula Model of Care, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06915259
- Acronym / sponsor ID
- 857762
- Conditions
- Perinatal, Morbidity, Mental Health
- Keywords
- Doula, community models of care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- March of Dimes
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Doula Model of CareParticipants 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. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide written consent by being unable to read or sign informed consent.
- PI Discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula Model of CareDoula model of care is defined as emotional support, prenatal support, intrapartum support, and postpartum support provided to the birthing individual by a certified doula. | Other | Doula Model of Care |
Primary outcome
Edinburgh Postpartum Depression Scale (EPDS) score
Time frame: After delivery up to 6 weeks postpartum
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
6 secondary outcomes
Obstetric outcomes: Mode of delivery
Time frame: At delivery
Obstetric outcomes: Preterm birth less than 37 weeks
Time frame: At delivery
Obstetric outcomes: Preterm birth less than 34 weeks
Time frame: At delivery
Self-efficacy
Time frame: Post-randomization to 6 weeks postpartum
Person centered prenatal care survey for people of color
Time frame: After delivery up to 6 weeks postpartum
Birth satisfaction (BSS-R survey)
Time frame: After delivery up to 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sindhu K Srinivas, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
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.