RecruitingNot ApplicableNCT06245057

Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

The ENHANCED Trial: Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity


Sponsor

University of Pennsylvania

Enrollment

2,300 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 55 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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)

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Interventions

OTHERMaternity care home model (MCHM)

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


Locations(2)

Hospital of the University of Pennsylvania

Phialdelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

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NCT06245057