RecruitingEarly Phase 1NCT05709483

Predictors of Aspirin Failure in Preeclampsia Prevention

Genetic, Laboratory and Clinical Factors Associated With Low-dose Aspirin Failure in the Prevention of Preeclampsia- An Exploratory Protocol

Sponsor

Rockefeller University

Enrollment

130 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Preeclampsia

Summary

Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating why aspirin, used to prevent preeclampsia (a dangerous high blood pressure condition in pregnancy), fails to work in some women. Researchers are looking for genetic and blood markers that predict who is most at risk. **You may be eligible if...** - You are a woman aged 18–45 who had preeclampsia in a previous pregnancy - In your next pregnancy, you took low-dose aspirin (81 mg) before 16 weeks and took it regularly (at least 80% of the time) - That pregnancy lasted beyond 20 weeks - You are willing to stop non-prescription anti-inflammatory drugs (like ibuprofen) for one week before the blood tests **You may NOT be eligible if...** - You are currently pregnant - You have a known reaction to aspirin - You have a bleeding disorder, kidney or liver problems, or chronic high blood pressure - You have diabetes, a current cancer diagnosis, or a history of hemorrhagic stroke - You are currently taking blood thinners 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

Platelet assays including VerifyNow Aspirin assay, VerifyNow Base assay, platelet aggregometry, Thromboxana A2 levels- will be measured at baseline and 1 hour after administration of single-dose enteric-coated 81 mg aspirin