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

Not Applicable

Recruiting

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Self Identifies as Non-Hispanic Black<br><br> - Between 16-49 years old<br><br> - Pregnant individuals between 8° - 226 weeks gestational age<br><br> - Live singleton or dichorionic twin gestation<br><br> - Dating sonogram at <23 weeks gestation,<br><br> - Area Deprivation Index (ADI) National 4th or 5th Quintile<br><br> - Planning to deliver at UAB Hospital<br><br> - Speaks and writes in English<br><br> - No indication for delivery at the time of enrollment<br><br>Exclusion Criteria:<br><br> - Declines randomization<br><br> - Speaks or writes in languages other than English<br><br> - Currently incarcerated<br><br> - Fetal demise diagnosed prior to enrollment<br><br> - Known major structural chromosomal abnormalities prior to enrollment<br><br> - Participated in POPPY Pilot

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weighted Adverse Outcome Score (WAOS)

Secondary Outcome Measures

Name	Time	Method
Outpatient Prenatal Care Visits;Preterm Birth;Neonatal birthweight;Cesarean delivery;Maternal blood transfusion;Breastfeeding intent;Maternal postpartum readmission;Neonatal hospital readmission