NCT06245057 · University of Pennsylvania
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
(ENHANCED)
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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.
Interventions
OTHER
Maternity care home model (MCHM)
The maternity care home model is defined as office based prenatal care integrated with comprehensive social services.
Primary outcome measures
Severe Maternal Morbidity (SMM)
Time frame: Delivery to one year postpartum
The CDC definition of SMM. We will also include postpartum hemorrhage, infection, thrombosis, readmission and maternal mortality within this definition
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Pregnant patients who self-identify as Black, Indigenous, Asian, or Latina (BIPOC)
- 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)
Where
- Phialdelphia, Pennsylvania
- Philadelphia, Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations