Improving care for Black birthing people with doulas
Doula Model of Care, A Randomized Controlled Trial
This study is testing whether adding doula support to standard hospital care can improve the birthing experience and mental health for Black individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 16 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06915259 on ClinicalTrials.gov |
What this trial studies
This randomized controlled intervention focuses on enhancing the birthing experience and outcomes for Black individuals by integrating doula care with standard hospital services at the Hospital of the University of Pennsylvania. Participants will receive either doula support, which includes prenatal visits, continuous labor support, and postpartum visits, or standard care without additional support. The study aims to address racial disparities in maternal health by assessing the impact of this integrated care model on mental health outcomes, specifically depression scores, among participants. The initiative seeks to foster trust and reduce bias in healthcare delivery for marginalized communities.
Who should consider this trial
Good fit: Ideal candidates are Black pregnant individuals aged 16-55 who are in their second trimester and plan to deliver at the Hospital of the University of Pennsylvania.
Not a fit: Patients who do not identify as Black or are outside the specified age range or gestational period may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health outcomes and overall birthing experiences for Black individuals.
How similar studies have performed: Other studies have shown promising results with community-based support models, indicating potential for success in this integrated approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sindhu K Srinivas, MD, MSCE — University of Pennsylvania
- Study coordinator: Sindhu K Srinivas, MD, MSCE
- Email: ssrinivas@pennmedicine.upenn.edu
- Phone: 215-662-2982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.