Actively Recruiting
Providing an Optimized and emPowered Pregnancy for You (PcOPPY) Aim 3: Randomized Controlled Trial
Led by University of Alabama at Birmingham · Updated on 2025-08-17
400
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating interventions to improve maternal and infant health outcomes, focusing on reducing disparities in care for Non-Hispanic Black pregnant individuals living in underserved communities. The study aims to support the American Heart Association's mission by identifying innovative and cost-effective strategies to enhance access to quality health information and care during pregnancy, postpartum, and preconception periods. This trial is part of the P3 EQUATE American Heart Association Health Equity Research Network and involves collaboration with families, hospitals, and communities to address racism and social issues impacting health outcomes. This trial uses a 2 x 2 factorial randomized controlled design with 400 Non-Hispanic Black participants living in high area deprivation index communities. Participants are randomly assigned to one of four groups: standard prenatal care alone; standard care plus a digital health intervention (DHI); standard care plus community health worker (CHW) support; or standard care plus both DHI and CHW interventions. The DHI delivers health care information via secure text message links, while the CHW program provides non-clinical, psychosocial, and emotional support from early pregnancy through postpartum. Participants will be followed from randomization through delivery and up to 6 weeks postpartum. Researchers will monitor outcomes such as the Weighted Adverse Outcome Score (WAOS), prenatal care visits, preterm birth, birthweight, cesarean delivery, maternal blood transfusion, breastfeeding intent, and hospital readmissions for mother and newborn. The study includes assessments of maternal and infant health, with data collected through routine care and study interventions, to evaluate whether these approaches reduce adverse pregnancy outcomes and improve health equity.
CONDITIONS
Brief Title
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identifies as Non-Hispanic Black
- Female aged between 16 and 49 years
- Pregnant with a singleton or dichorionic twin gestation between 8 and 22 weeks
- Has a dating sonogram at less than 23 weeks gestation
- Lives in a community with Area Deprivation Index in the national 4th or 5th quintile
- Plans to deliver at UAB Hospital
- Speaks and writes in English
- No indication for delivery at the time of enrollment
You will not qualify if you...
- 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 previously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery of the infant(s)
Participants receive standard prenatal care services with or without additional Digital Health and/or Community Health Worker interventions to support maternal and perinatal health.
Regular prenatal care visits as per routine healthcare
Duration - Up to 6 weeks postpartum
Participants are followed for health outcomes from delivery through 6 weeks postpartum, including maternal and neonatal assessments.
Visits up to 6 weeks postpartum as part of routine care
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
R
Rosylen "Roz" Quinney
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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