N/A
N=40
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
Pregnancy · Infants · Disparities
Bottom Line
View on ClinicalTrials.gov: NCT05940688 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Participant Acceptance of Randomization Arm / Intervention — 8; 8; 10; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digital Health intervention (Behavioral); Community Health Worker (Behavioral); Digital Health Intervention plus Community Health Worker (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Acceptance of Randomization Arm / Intervention |
8; 8; 10; 7; 1; 2 | — |
| PRIMARY Participant Use of Digital Health and/or Community Health Worker Interventions |
— | — |
| SECONDARY Outpatient Perinatal Care Visits |
13; 9.5; 9; 12 | — |
| SECONDARY Preterm Birth |
2; 1; 4; 3; 7; 7 | — |
| SECONDARY Neonatal Birthweight |
3160.0; 3150.0; 2815.0; 2920.0 | — |
| SECONDARY Cesarean Delivery |
7; 5; 3; 3; 2; 3 | — |
| SECONDARY Maternal Blood Transfusion |
1; 0; 1; 2; 8; 8 | — |
| SECONDARY Breastfeeding Intent |
2; 1; 1; 2; 3; 3 | — |
| SECONDARY Vaccination Rate |
7; 4; 5; 5; 2; 6 | — |
| SECONDARY Maternal Postpartum Readmission |
0; 0; 1; 2; 9; 10 | — |
| SECONDARY Neonatal Hospital Readmission |
8; 8; 7; 7; 0; 0 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05940688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.