Status:
RECRUITING
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
American Heart Association
ConnectionHealth
Conditions:
Pregnancy Complications
Maternal Distress
Eligibility:
FEMALE
16-49 years
Phase:
NA
Brief 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...
Detailed Description
The aim of this trial is to assess whether an existing Digital Heath Intervention (DHI) and/or a Community Health Worker (CHW) Intervention will reduce adverse maternal and perinatal outcomes. A 2 x 2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06510075
Start Date
August 1 2024
End Date
January 31 2027
Last Update
August 17 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233