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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
Health care information delivered via a link in a text message that is then opened in a secure browser.
Health care information delivered via CHW.
Health care information delivered via DHI plus CHW
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGWeighted 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: [Time Frame: From randomization to 6 weeks postpartum]
Outpatient Prenatal Care Visits
Number of outpatient prenatal care and postpartum visits
Time frame: Duration of pregnancy through 6 weeks postpartum
Preterm Birth
Delivery of a neonate at less than 37 weeks
Time frame: At birth
Neonatal birthweight
Weight of neonate at birth
Time frame: At birth
Cesarean delivery
Occurrence of a cesarean birth
Time frame: At birth
Maternal blood transfusion
Transfusion of blood products
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Birth to 6 weeks of life
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