Adverse Birth Outcomes, Infant Conditions, Maternal Distress, Pregnancy Complications
Conditions
Keywords
Pregnancy outcomes, Health inequities
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.
Interventions
BEHAVIORALDigital Health intervention
Health care information delivered via a link in a text message that is then opened in a secure browser.
BEHAVIORALCommunity Health Worker
Health care information delivered via CHW.
Health care information delivered via DHI plus CHW
Sponsors
University of Alabama at Birmingham
American Heart Association
ConnectionHealth
Memora Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Intervention model description
Study is a randomized trial (n=400) randomizing eligible participants to usual care (n=100), or usual care plus a digital health intervention (n=100), or usual care plus a community health worker intervention (n=100), or usual care plus both a digital health intervention and a community health worker intervention (n=100).
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Adverse Outcome Score (WAOS) | [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
| Measure | Time frame | Description |
|---|---|---|
| Outpatient Prenatal Care Visits | Duration of pregnancy through 6 weeks postpartum | Number of outpatient prenatal care and postpartum visits |
| Preterm Birth | At birth | Delivery of a neonate at less than 37 weeks |
| Neonatal birthweight | At birth | Weight of neonate at birth |
| Cesarean delivery | At birth | Occurrence of a cesarean birth |
| Maternal blood transfusion | Duration of pregnancy through 6 weeks postpartum | Transfusion of blood products |
| Breastfeeding intent | From randomization to delivery of the infant(s) | Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization |
| Maternal postpartum readmission | From discharge from the delivery-associated hospitalization to 6 weeks postpartum | Admission of the mother to the hospital after discharge from the delivery-associated hospitalization |
| Neonatal hospital readmission | Birth to 6 weeks of life | Admission of a neonate to the hospital after discharge from the hospital after birth |
Countries
United States
Contacts
CONTACTRosylen "Roz" Quinney
PRINCIPAL_INVESTIGATORRachel Sinkey, MD
University of Alabama at Birmingham
PRINCIPAL_INVESTIGATORWally Carlo, MD
University of Alabama at Birmingham
Outcome results
None listed