RecruitingPhase 1Phase 2NCT06826859

Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)

Dose Based Aspirin Pharmacokinetics and Pharmacodynamics in Pregnancy and Association With Pregnancy Outcomes


Sponsor

Thomas Jefferson University

Enrollment

400 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study (DASH) is comparing two ways of taking low-dose aspirin during pregnancy for women at high risk of preeclampsia (dangerously high blood pressure during pregnancy): taking the full daily dose once a day versus splitting it into two smaller doses. **You may be eligible if...** - You are pregnant - You are at high risk for preeclampsia (due to factors like a previous case, chronic high blood pressure, diabetes, or carrying twins) - You are in the first or early second trimester of pregnancy - Your doctor has already recommended low-dose aspirin for your pregnancy **You may NOT be eligible if...** - You have an allergy or intolerance to aspirin - You have a bleeding disorder or are on anticoagulant medication - You have a stomach ulcer or serious gastrointestinal condition - Your pregnancy has serious complications already requiring different management 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

DRUGDaily aspirin (ASA)

162mg aspirin taken daily

DRUGSplit dose aspirin (ASA)

81mg aspirin q12hours


Locations(1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

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NCT06826859


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