Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity (NCT06245057) | Clinical Trial Compass
RecruitingNot Applicable
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
United States2,300 participantsStarted 2024-01-30
Plain-language 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.
Who can participate
Age range
16 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.