Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06245057

Conditions

Morbidity;Perinatal

Eligibility Criteria

Sex: Female

Age: 16 - 55

Healthy Volunteers: Accepted

Interventions

Maternity care home model (MCHM)

Study Details

Brief 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

Study ID

NCT06245057

Start date

Jan 30, 2024

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

2300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Maternity care home model (MCHM)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sindhu K Srinivas, MD, MSCE

215-662-2982ssrinivas@pennmedicine.upenn.edu

Elizabeth Norton, MPH, MBE

215-349-5277elizabeth.norton@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Phialdelphia, Pennsylvania, United States, 19104

Contacts

Elizabeth Norton, MPH, MBE

215-349-5277elizabeth.norton@pennmedicine.upenn.edu

Meaghan McCabe, MPH

215-349-5277meaghan.mccabe@pennmedicine.upenn.edu

Principal Investigator:

Sindhu K Srinivas, MD, MSCE

More Information

Sponsor

University of Pennsylvania

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Prenatal care
  • Disparity
  • Maternity care home model
  • Pregnancy home
  • Severe maternal morbidity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-04-21.