Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Official title: A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth

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.

Conditions: Preterm Delivery, Obstetrical Complications

Keywords: Preterm Delivery, Stillbirth, Maternal Morbidity, Neonatal Morbidity, Prevention

Study type: INTERVENTIONAL

Primary purpose: PREVENTION

Phases: PHASE3

Enrollment: 1800 (ESTIMATED)

Status: RECRUITING

Completion: 2029-02-28 (ESTIMATED)