Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
NCT Number: NCT06510075
Acronym: P3OPPY
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Complications|Maternal Distress|Adverse Birth Outcomes|Infant Conditions
Interventions: BEHAVIORAL: Digital Health intervention|BEHAVIORAL: Community Health Worker|BEHAVIORAL: Digital Health Intervention plus Community Health Worker
Sponsor: University of Alabama at Birmingham
Collaborators: American Heart Association|ConnectionHealth|Memora Health
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2027-01-31
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States

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.

Primary Outcome Measures: Weighted Adverse Outcome Score (WAOS), 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., [Time Frame: From randomization to 6 weeks postpartum]
Secondary Outcome Measures: Outpatient Prenatal Care Visits, Number of outpatient prenatal care and postpartum visits, Duration of pregnancy through 6 weeks postpartum|Preterm Birth, Delivery of a neonate at less than 37 weeks, At birth|Neonatal birthweight, Weight of neonate at birth, At birth|Cesarean delivery, Occurrence of a cesarean birth, At birth|Maternal blood transfusion, Transfusion of blood products, Duration of pregnancy through 6 weeks postpartum|Breastfeeding intent, Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization, From randomization to delivery of the infant(s)|Maternal postpartum readmission, Admission of the mother to the hospital after discharge from the delivery-associated hospitalization, From discharge from the delivery-associated hospitalization to 6 weeks postpartum|Neonatal hospital readmission, Admission of a neonate to the hospital after discharge from the hospital after birth, Birth to 6 weeks of life