Clinical trial NCT06510075: Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
Official title: Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Complications
Maternal Distress
Adverse Birth Outcomes
Infant Conditions
Keywords: Pregnancy outcomes
Health inequities
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: ConnectionHealth
name: Memora Health
First posted: 2024-07-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weighted Adverse Outcome Score (WAOS)
timeFrame: [Time Frame: From randomization to 6 weeks postpartum]
Secondary outcomes:
measure: Outpatient Prenatal Care Visits
timeFrame: Duration of pregnancy through 6 weeks postpartum
measure: Preterm Birth
timeFrame: At birth
measure: Neonatal birthweight
timeFrame: At birth
measure: Cesarean delivery
timeFrame: At birth
measure: Maternal blood transfusion
timeFrame: Duration of pregnancy through 6 weeks postpartum
measure: Breastfeeding intent
timeFrame: From randomization to delivery of the infant(s)
measure: Maternal postpartum readmission
timeFrame: From discharge from the delivery-associated hospitalization to 6 weeks postpartum
measure: Neonatal hospital readmission
timeFrame: Birth to 6 weeks of life
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Rachel Sinkey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Wally Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References: