Integrated maternity care model to reduce severe maternal morbidity in BIPOC patients
Official title: The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
Run by University of Pennsylvania · NCT06245057 · Data updated 2026-11-12
This study is testing a new maternity care model that combines prenatal care with social services to see if it can help reduce serious health problems for Black, Indigenous, and people of color during and after pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 55 Years |
| Sex | Women only |
| Enrollment | 2300 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Phialdelphia, Pennsylvania and 1 other locations) |
| Status | Recruiting |
| Started | January 30, 2024 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2028 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT06245057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant individuals aged 16-55 who self-identify as Black, Indigenous, Asian, or Latina and plan to deliver at the participating hospitals.
✕Probably not a fit
Patients who are unable to provide written consent or are already enrolled in a similar maternity care model will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled intervention evaluates a comprehensive maternity care home model (MCHM) designed to reduce severe maternal morbidity (SMM) among Black, Indigenous, and people of color (BIPOC) patients. The study compares the MCHM, which integrates prenatal care with social services, to standard care that relies on outsourced social service referrals. Participants will be followed throughout their pregnancy and up to one year postpartum to assess the effectiveness of this integrated approach in addressing social and structural inequities. The trial aims to provide a holistic solution to the disparities faced by vulnerable populations in maternal health.
Why it matters
Potential benefit: If successful, this approach could significantly reduce severe maternal morbidity and improve health outcomes for BIPOC patients during and after pregnancy.
How similar studies have gone: While previous studies have explored single social determinants, this integrated approach is novel and aims to comprehensively address multiple factors affecting maternal health disparities.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC) * Ages 16-55 * Presentation to the hospital in pregnancy - this includes prenatal care or the emergency department * Plan to deliver at the 2 Penn hospital sites * Patients must be able to read and understand English or Spanish * 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. * Enrolled in ENHANCED Trial in a prior pregnancy * Already participating in Maternity Care Home Model (MCHM)
Where it's running
-
Hospital of the University of Pennsylvania
Phialdelphia, Pennsylvania, United States Recruiting -
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States Not yet 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.