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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rachel Sinkey, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
- Wally Carlo, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.