Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Status:
RECRUITING
Trial end date:
2029-02-28
Target enrollment:
Participant gender:
Summary
This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.
Phase:
PHASE3
Details
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborators:
Columbia University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)