Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

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.

NCT Number	NCT06980025
Lead Sponsor	The George Washington University Biostatistics Center Collaborators: Columbia University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Preterm Delivery, Obstetrical Complications
Enrollment	1,800 participants
Start Date	2025-07-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-04-09