Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. The main question it aims to answer is whether
| Condition(s) | Morbidity;Perinatal |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM. Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum. |
| Who can participate | 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) |
| Ages | 16 Years to 55 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Pennsylvania |
| Locations | Phialdelphia, Pennsylvania, United States; Philadelphia, Pennsylvania, United States |
| Start date | 2024-01-30 |
| NCT ID | NCT06245057 |
| Official listing | https://clinicaltrials.gov/study/NCT06245057 |