Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Start Date
7/1/2025
Completion Date
2/28/2029
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.
Detailed Description
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 primary objective is to assess the efficacy of daily 162 mg of aspirin compared to 81 mg aspirin in reducing recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation in individuals with a proximal birth between 20 weeks, 0 days and 34 weeks, 6 days gestation with spontaneous preterm delivery (sPTB), ischemic placental disease (IPD), or stillbirth. Ischemic placental disease includes small for gestational age, preeclampsia, or placental abruption. The secondary objective is to assess the efficacy of daily 162 mg of aspirin compared to 81 mg aspirin in reducing ischemic placental disease in individuals with a proximal birth between 20 weeks, 0 days and 34 weeks, 6 days gestation with sPTB, IPD, or stillbirth. Tertiary /Exploratory objectives are 1) to assess the efficacy of daily 162 mg of aspirin compared to 81 mg aspirin in reducing adverse maternal and neonatal outcomes, and 2) to assess maternal and neonatal safety in individuals with a proximal birth between 20 weeks, 0 days and 34 weeks, 6 days gestation with sPTB, IPD, or stillbirth. Individuals will be randomized between 10 and 15 weeks gestation to either 162mg or 81mg of aspirin daily and continue the study intervention through 36 weeks, 6 days gestation. Participants will have monthly virtual or in-person visits through 37 weeks gestation to assess study intervention compliance, side effects, medication use, and unscheduled hospitalization. Maternal blood will be collected in a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital.
Eligibility Criteria
Age Range: 14 years to No maximum
Interventions
162mg Aspirin
81mg Aspirin
Conditions
Locations
University of Alabama - Birmingham
Birmingham, Alabama 35233
United States
Regents of the University of California San Francisco
San Francisco, California 94143
United States
Northwestern University
Chicago, Illinois 60611
United States
Columbia University
New York, New York 10032
United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599
United States
Duke University
Durham, North Carolina 27710
United States
Case Western Reserve University
Cleveland, Ohio 44109
United States
Ohio State University
Columbus, Ohio 43210
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania 15213
United States
Brown University
Providence, Rhode Island 02905
United States
Baylor College of Medicine
Houston, Texas 77030
United States
University of Texas - Houston
Houston, Texas 77030
United States
University of Utah Medical Center
Salt Lake City, Utah 84132
United States