Integrated maternity care model to reduce severe maternal morbidity in BIPOC patients
The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2300 (estimated) |
| Ages | 16 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Phialdelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06245057 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While previous studies have explored single social determinants, this integrated approach is novel and aims to comprehensively address multiple factors affecting maternal health disparities.
Eligibility criteria
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 this trial is running
Phialdelphia, Pennsylvania and 1 other locations
- 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
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.