Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial (NCT06510075) | Clinical Trial Compass
RecruitingNot Applicable
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
United States400 participantsStarted 2024-08-01
Plain-language summary
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.
Who can participate
Age range
16 Years – 49 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:
* Self Identifies as Non-Hispanic Black
* Between 16-49 years old
* Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
* Live singleton or dichorionic twin gestation
* Dating sonogram at \<23 weeks gestation,
* Area Deprivation Index (ADI) National 4th or 5th Quintile
* Planning to deliver at UAB Hospital
* Speaks and writes in English
* No indication for delivery at the time of enrollment
Exclusion Criteria:
* Declines randomization
* Speaks or writes in languages other than English
* Currently incarcerated
* Fetal demise diagnosed prior to enrollment
* Known major structural chromosomal abnormalities prior to enrollment
* Participated in POPPY Pilot
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.
What they're measuring
1
Weighted Adverse Outcome Score (WAOS)
Timeframe: [Time Frame: From randomization to 6 weeks postpartum]