Optimizing Pregnancy Outcomes for Non-Hispanic Black Mothers
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
NA · University of Alabama at Birmingham · NCT06510075
This study is testing if a new digital health program and support from community health workers can help improve pregnancy outcomes for Non-Hispanic Black mothers living in underserved areas.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 16 Years to 49 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06510075 on ClinicalTrials.gov |
What this trial studies
The POPPY project aims to improve maternal and infant health outcomes by addressing health inequities faced by Non-Hispanic Black individuals. This randomized controlled trial will evaluate the effectiveness of a Digital Health Intervention and/or a Community Health Worker Intervention in reducing adverse maternal and perinatal outcomes. Participants will be randomized into four groups to receive varying combinations of standard prenatal care, digital health support, and community health worker assistance. The study focuses on pregnant individuals living in high area deprivation index communities, collaborating with families and healthcare providers to enhance access to quality care.
Who should consider this trial
Good fit: Ideal candidates are Non-Hispanic Black pregnant individuals aged 16-49, between 8 to 22 weeks gestational age, planning to deliver at UAB Hospital.
Not a fit: Patients who do not identify as Non-Hispanic Black or those with significant medical complications that require specialized care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes for Non-Hispanic Black mothers and their infants, particularly in underserved communities.
How similar studies have performed: Other studies have shown promise in using digital health and community health worker interventions to improve maternal health outcomes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Rachel Sinkey, MD — University of Alabama at Birmingham
- Study coordinator: Rosylen "Roz" Quinney
- Email: rquinney@uabmc.edu
- Phone: 205.934.1309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Complications, Maternal Distress, Adverse Birth Outcomes, Infant Conditions, Pregnancy outcomes, Health inequities