Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Recruiting now · Not applicable

Conditions studied: Morbidity;Perinatal

In brief

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.

Key facts

Study ID

NCT06245057

Run by

University of Pennsylvania

People needed

2300

Starts

2024-01-30

Expected to finish

2028-01-31

Last updated by the study team

2026-04-21

Who can join

Age: 16 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Hospital of the University of Pennsylvania — Phialdelphia, Pennsylvania, United States (enrolling)
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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