About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Declines randomization
Speaks or writes in languages other than English
Currently incarcerated
Fetal demise diagnosed prior to enrollment
Trial design
Parallel
Treatments tested in this trial
Digital Health intervention
BehavioralHealth care information delivered via a link in a text message that is then opened in a secure browser.
Community Health Worker
BehavioralHealth care information delivered via CHW.
Digital Health Intervention plus Community Health Worker
BehavioralHealth care information delivered via DHI plus CHW
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Outpatient Prenatal Care Visits
Number of outpatient prenatal care and postpartum visits
Preterm Birth
Delivery of a neonate at less than 37 weeks
Neonatal birthweight
Weight of neonate at birth
Cesarean delivery
Occurrence of a cesarean birth
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
American Heart Association
Collaborator
ConnectionHealth
Collaborator
Memora Health
Collaborator