Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Part of paid clinical trials in Phialdelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06245057
Status
Recruiting
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Conditions

  • Morbidity;Perinatal

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Maternity care home model (MCHM) — OTHER
    The maternity care home model is defined as office based prenatal care integrated with comprehensive social services.

Study Details

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 Dates

Start date
Jan 30, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
2,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Maternity care home model (MCHM)
    Office based prenatal care integrated with comprehensive social services within the maternity care home model.
  • No Intervention: Usual care arm
    Office based prenatal care with individually outsourced social service referrals.

Primary Outcome Measure

Severe Maternal Morbidity (SMM) [ Time Frame: Delivery to one year postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhialdelphiaPennsylvania19104
Elizabeth Norton, MPH, MBE
[email protected]
215-349-5277
Meaghan McCabe, MPH
[email protected]
215-349-5277
Sindhu K Srinivas, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Lisa D Levine, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Pennsylvania HospitalPhiladelphiaPennsylvania19107
Elizabeth Norton, MPH, MBE
[email protected]
215-349-5277
Meaghan McCabe, MPH
[email protected]
215-349-5277
Sindhu K Srinivas, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Lisa D Levine, MD, MSCE (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phialdelphia, PA

By research site
Hospital of the University of Pennsylvania· Phialdelphia, PAPennsylvania Hospital· Philadelphia, PA

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