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Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

NCT06245057 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2300

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Morbidity;Perinatal

Interventions

OTHER

Maternity care home model (MCHM)

The maternity care home model is defined as office based prenatal care integrated with comprehensive social services.

Sponsors & Collaborators

Principal Investigators

  • Sindhu K Srinivas, MD, MSCE · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245057 on ClinicalTrials.gov