Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker.
- Who it may be relevant to
- Registry conditions: Pregnancy Complications, Maternal Distress, Adverse Birth Outcomes, Infant Conditions. Basic parameters: 16 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
Overview
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
- Behavioral Digital Health intervention
Health care information delivered via a link in a text message that is then opened in a secure browser. - Behavioral Community Health Worker
Health care information delivered via CHW. - Behavioral Digital Health Intervention plus Community Health Worker
Health care information delivered via DHI plus CHW
Primary outcome measures
- Weighted Adverse Outcome Score (WAOS) [Time frame: [Time Frame: From randomization to 6 weeks postpartum]]
Secondary outcome measures (8)
- Outpatient Prenatal Care Visits [Time frame: Duration of pregnancy through 6 weeks postpartum]
- Preterm Birth [Time frame: At birth]
- Neonatal birthweight [Time frame: At birth]
- Cesarean delivery [Time frame: At birth]
- Maternal blood transfusion [Time frame: Duration of pregnancy through 6 weeks postpartum]
- Breastfeeding intent [Time frame: From randomization to delivery of the infant(s)]
- Maternal postpartum readmission [Time frame: From discharge from the delivery-associated hospitalization to 6 weeks postpartum]
- Neonatal hospital readmission [Time frame: Birth to 6 weeks of life]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06510075 · IRB-300013085 · 22HERNPMI985239