POPPY Study for Pregnancy Complications and Maternal Distress

The POPPY study is looking for Non-Hispanic Black pregnant individuals, aged 16-49, who are between 8 and 22 weeks pregnant with a single baby or dichorionic twins. You must also live in an area with a high Area Deprivation Index (ADI) and plan to deliver at UAB Hospital. This study aims to improve maternal and infant health by testing if a Digital Health intervention (health information by text message link) and/or a Community Health Worker (CHW) intervention (health information from a CHW) can reduce pregnancy complications and improve birth outcomes. The study will compare these interventions to standard prenatal care. Success will be measured by a Weighted Adverse Outcome Score (WAOS) from when you join until 6 weeks after birth. The current recruitment status is unclear, and the study plans to enroll 400 participants.

Study design
This study is an interventional trial that will randomly assign 400 participants to one of four groups: standard prenatal care alone, standard care plus Digital Health Intervention, standard care plus Community Health Worker, or standard care plus both interventions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from when they join the study until 6 weeks after giving birth.

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NCT06510075

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

Recruiting
NAAges 16–49InterventionalPrevention
University of Alabama at Birmingham
~400 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Digital Health interventionCommunity Health WorkerDigital Health Intervention plus Community Health Worker

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weighted Adverse Outcome Score (WAOS)
Measured over [Time Frame: From randomization to 6 weeks postpartum]
Pregnancy Complications
Maternal Distress
Adverse Birth Outcomes
Infant Conditions
1 sites across 1 states
Alabama1
  • Rachel Sinkey, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
  • Wally Carlo, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • 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.