Aspirin Dose Escalation Study for Preventing Recurrent Preterm Birth

What this Trial Is About

Researchers are evaluating the use of two different daily doses of aspirin (162 mg versus 81 mg) to prevent recurrent preterm birth or fetal death before 35 weeks gestation in individuals with a history of prior preterm birth. This phase-III, multi-center, double-blind, randomized clinical trial focuses on participants who had a previous birth between 20 weeks, 0 days and 34 weeks, 6 days gestation complicated by spontaneous preterm birth, ischemic placental disease, or stillbirth. The primary goal is to compare the effectiveness of these aspirin doses in reducing these adverse pregnancy outcomes. Participants will be randomly assigned between 10 and 15 weeks gestation to receive either one 81 mg aspirin capsule or two 81 mg aspirin capsules (totaling 162 mg) daily. The study medication will be taken until 36 weeks, 6 days gestation. Monthly virtual or in-person visits will monitor adherence, side effects, medication use, and any hospitalizations. Some participants will provide maternal blood samples for additional research. After delivery and hospital discharge, research staff will collect maternal and neonatal health information. During the trial, participants will undergo regular assessments to track compliance and side effects of the aspirin regimens. The main measurement is the rate of recurrent preterm delivery or fetal death before 35 weeks gestation. Secondary outcomes include rates of ischemic placental disease. Safety for both mothers and newborns will also be evaluated. The full participation period covers from early pregnancy through delivery and postpartum hospital discharge, with follow-up visits until 37 weeks gestation to ensure thorough monitoring.

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial