Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Pregnancy Complications; Infant Conditions; Maternal Distress; Adverse Birth Outcomes

• Registration Number: NCT06510075
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-07-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 blood transfusion	Duration of pregnancy through 6 weeks postpartum	Transfusion of blood products
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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States