Actively Recruiting

Phase Not Applicable
Age: 16Years - 55Years
FEMALE
Healthy Volunteers
NCT06245057

Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Led by University of Pennsylvania · Updated on 2026-04-21

2300

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Who Can Participate

Age: 16Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
  • Aged 16 to 55 years
  • Presenting to the hospital during pregnancy, including prenatal care or emergency department
  • Planning to deliver at the two Penn hospital sites
  • Able to read and understand English or Spanish
  • Willing and able to sign the informed consent form
Not Eligible

You will not qualify if you...

  • Unable to provide written consent due to inability to read or sign the consent form
  • Previously enrolled in the ENHANCED Trial during a prior pregnancy
  • Currently participating in the Maternity Care Home Model (MCHM)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Hospital of the University of Pennsylvania

Phialdelphia, Pennsylvania, United States, 19104

Actively Recruiting

2

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19107

Not Yet Recruiting

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Research Team

S

Sindhu K Srinivas, MD, MSCE

CONTACT

E

Elizabeth Norton, MPH, MBE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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