NCT06245057

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Jan 2024Jan 2028

First Submitted

Initial submission to the registry

January 17, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

January 17, 2024

Last Update Submit

April 16, 2026

Conditions

Morbidity;Perinatal

Keywords

Prenatal careDisparityMaternity care home modelPregnancy homeSevere maternal morbidity

Outcome Measures

Primary Outcomes (1)

  • Severe Maternal Morbidity (SMM)

    The CDC definition of SMM. We will also include postpartum hemorrhage, infection, thrombosis, readmission and maternal mortality within this definition

    Delivery to one year postpartum

Secondary Outcomes (13)

  • Obstetric outcomes: Mode of delivery

    At delivery

  • Obstetric outcomes: Preterm birth less than 37 weeks

    At delivery

  • Obstetric outcomes: Preterm birth less than 34 weeks

    At delivery

  • Obstetric outcomes: Hypertensive disorders of pregnancy

    During pregnancy through 6 weeks postpartum

  • Composite adverse neonatal outcome

    From birth until 4 months after birth

  • +8 more secondary outcomes

Study Arms (2)

Maternity care home model (MCHM)

EXPERIMENTAL

Office based prenatal care integrated with comprehensive social services within the maternity care home model.

Other: Maternity care home model (MCHM)

Usual care arm

NO INTERVENTION

Office based prenatal care with individually outsourced social service referrals.

Interventions

Maternity care home model (MCHM)OTHER

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

Maternity care home model (MCHM)

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Phialdelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Study Officials

  • Sindhu K Srinivas, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindhu K Srinivas, MD, MSCE

CONTACT

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

Elizabeth Norton, MPH, MBE

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair for Quality and Safety, Department OBGYN

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 7, 2024

Study Start

January 30, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)