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Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Sponsor: The George Washington University Biostatistics Center
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.
Official title: A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth
Key Details
Gender
FEMALE
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2025-07-01
Completion Date
2029-02-28
Last Updated
2026-04-09
Healthy Volunteers
Yes
Interventions
162mg Aspirin
Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
81mg Aspirin
One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
Locations (14)
University of Alabama - Birmingham
Birmingham, Alabama, United States
Regents of the University of California San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States