Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy Complications
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Weighted Adverse Outcome Score (WAOS)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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 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.
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 factorial randomized controlled trial of Non-Hispanic Black (NHB) patients living in high area deprivation index (ADI) communities will be conducted. Participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (PNC) alone, or 2) standard PNC plus DHI, or 3) standard PNC plus CHW, or 4) standard PNC, plus DHI and CHW. 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 promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond.
Investigators
Rachel Sinkey
Associate Professor
University of Alabama at Birmingham
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
- •Participated in POPPY Pilot
Outcomes
Primary Outcomes
Weighted Adverse Outcome Score (WAOS)
Time Frame: [Time Frame: From randomization to 6 weeks postpartum]
WAOS, calculated by adding the weights of all adverse events divided by the total number of deliveries. Maternal death=750, Neonatal death=400, Uterine rupture=100, Maternal ICU Admission=65, Birth trauma=60, Unanticipated operative procedure=40, NICU Admission=35, 5-minute Apgar \<7=25, Maternal blood transfusion=20, and 4th degree perineal lacerations=5.
Secondary Outcomes
- Outpatient Prenatal Care Visits(Duration of pregnancy through 6 weeks postpartum)
- Preterm Birth(At birth)
- Neonatal birthweight(At birth)
- Cesarean delivery(At birth)
- Breastfeeding intent(From randomization to delivery of the infant(s))
- Maternal blood transfusion(Duration of pregnancy through 6 weeks postpartum)
- Maternal postpartum readmission(From discharge from the delivery-associated hospitalization to 6 weeks postpartum)
- Neonatal hospital readmission(Birth to 6 weeks of life)