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NCT06510075 · ClinicalTrials.gov registry record · NA
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
A NA study of Pregnancy Complications and Maternal Distress, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT06510075: Recruiting NA study of Pregnancy Complications and Maternal Distress, sponsored by University of Alabama at Birmingham.
NCT06510075 is a NA study of Pregnancy Complications and Maternal Distress that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 400 participants, below the 3,781-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06510075, a NA study of Pregnancy Complications and Maternal Distress, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Community Health Worker
- BEHAVIORAL Digital Health intervention
- BEHAVIORAL Digital Health Intervention plus Community Health Worker
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
What NCT06510075 shows while recruiting
NCT06510075 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 3,781-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (89% lower).
The record links to 4 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 3 interventions - of which Community Health Worker is the first listed.
NCT06510075 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06510075 about?
NCT06510075 is a clinical study titled "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 ...
What is the current status of trial NCT06510075?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-08-01. Estimated completion is 2027-01-31.
What conditions does trial NCT06510075 study?
This clinical trial studies the following conditions: Pregnancy Complications, Maternal Distress, Infant Conditions, Adverse Birth Outcomes.
What interventions are being tested in trial NCT06510075?
The interventions under investigation include: Community Health Worker (BEHAVIORAL), Digital Health intervention (BEHAVIORAL), Digital Health Intervention plus Community Health Worker (BEHAVIORAL).
Who is sponsoring clinical trial NCT06510075?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06510075 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06510075's enrollment target sits among peer trials
400 17th of 39 higher than 22 of 39 other Pregnancy Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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