RecruitingPhase 4NCT06468202

Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

Sponsor

Ohio State University

Enrollment

10,742 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Preeclampsia Hypertensive Disorders of Pregnancy Gestational Hypertension

Summary

The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.

Eligibility

Sex: FEMALEMin Age: 14 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different doses of aspirin to find out which is more effective at preventing preeclampsia (a dangerous high blood pressure complication) and related pregnancy complications in people at higher risk. You may be eligible if: you are at least 14 years old; you are no more than 16 weeks and 6 days pregnant; and you have at least one high-risk factor for preeclampsia (such as a prior preeclampsia history, chronic high blood pressure, pre-existing diabetes, twin pregnancy, kidney disease, or an autoimmune condition) or two or more moderate-risk factors. You may NOT be eligible if: you have an aspirin allergy or a condition where aspirin is unsafe; you are already taking aspirin for a non-pregnancy reason; you are involuntarily confined; your fetus has a known serious abnormality; or you have a higher-order pregnancy (triplets or more). Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin 81 mg

Participants will be assigned to 81mg Aspirin

DRUGAspirin 162 mg

Participants will be assigned to 162mg Aspirin

Locations(16)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Northwestern University

Chicago, Illinois, United States

University of Mississippi

Jackson, Mississippi, United States

University of New Mexico

Albuquerque, New Mexico, United States

Columbia University

New York, New York, United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

University of Pittsburg Magee

Pittsburgh, Pennsylvania, United States

Brown University

Providence, Rhode Island, United States

University of Texas, Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Inova HealthSystem

Falls Church, Virginia, United States

Eastern Virginia Medical School - Old Dominion University

Norfolk, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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