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RECRUITING
NCT06980025
PHASE3

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Sponsor: The George Washington University Biostatistics Center

View on ClinicalTrials.gov

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

DRUG

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).

DRUG

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