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NCT Number: NCT06510075

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

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.

Recruiting

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Key information

Conditions

Pregnancy Complications Adverse Birth Outcomes Female Urogenital Diseases and Pregnancy Complications Infant Conditions Maternal Distress Urogenital Diseases

Age range

16 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Rosylen Quinney

CONTACT

[email protected]

205.934.1309

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Health Intervention

Behavioral

Health care information delivered via a link in a text message that is then opened in a secure browser.

Other names: DHI

Community health worker

Behavioral

Health care information delivered via CHW.

Other names: CHW

Digital Health Intervention plus Community Health Worker

Behavioral

Health care information delivered via DHI plus CHW

Other names: DHI plus CHW

Primary outcomes

  1. Weighted Adverse Outcome Score (WAOS)

    Time frame: [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 outcomes

  1. Outpatient Prenatal Care Visits

    Time frame: Duration of pregnancy through 6 weeks postpartum

    Number of outpatient prenatal care and postpartum visits

  2. Preterm Birth

    Time frame: At birth

    Delivery of a neonate at less than 37 weeks

  3. Neonatal birthweight

    Time frame: At birth

    Weight of neonate at birth

  4. Cesarean delivery

    Time frame: At birth

    Occurrence of a cesarean birth

  5. Maternal blood transfusion

    Time frame: Duration of pregnancy through 6 weeks postpartum

    Transfusion of blood products

  6. Breastfeeding intent

    Time frame: 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

  7. Maternal postpartum readmission

    Time frame: 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

  8. Neonatal hospital readmission

    Time frame: Birth to 6 weeks of life

    Admission of a neonate to the hospital after discharge from the hospital after birth

Study contacts

Contact information is provided by the study sponsor or research team.

Rosylen "Roz" Quinney

CONTACT

[email protected]

205.934.1309

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Heart Association
  • ConnectionHealth
  • Memora Health

Registry information

Official study title

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial

Acronym: P3OPPY

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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