Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)
NCT ID: NCT04295850
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
130 participants
OBSERVATIONAL
2020-08-21
2023-06-30
Brief Summary
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Detailed Description
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Aim 1: Establish pharmacodynamic endpoints for aspirin in prevention of HDP Hypothesis: PFA-100 closure time and serum thromboxane/urinary dehydrothromboxane-B2 (dTX-B2) are pharmacodynamic markers of aspirin response and are predictive of HDP high risk pregnant patients.
Aim 2: Explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of HDP Hypothesis: Platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of HDP.
Aim 3: Assess the utility of circulating microRNA as a marker of aspirin response in pregnancy and risk of HDP Hypothesis: Quantitative expression of selected miRNAs are biomarkers for response to aspirin therapy and risk of HDP.
Aim 4: Evaluate aspirin pharmacokinetics/pharmacodynamics Hypothesis: Individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Low Dose Aspirin
Pregnant singletons at high risk for preeclampsia based on:
* at least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, lupus, antiphospholipid antibody syndrome, or chronic kidney disease. OR
* at least two of the following: BMI\>30, black race, state insurance, IVF pregnancy, advanced maternal age, nulliparous or \>10yr from last delivery, prior adverse pregnancy outcome
who are planning to, but have not yet started, aspirin therapy \<16 weeks' gestation. Patients will take 81mg aspirin as prescribed.
Aspirin 81 mg
Aspirin 81mg daily PO
Interventions
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Aspirin 81 mg
Aspirin 81mg daily PO
Eligibility Criteria
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Inclusion Criteria
* At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome
Exclusion Criteria
* Current or planned use of any other anticoagulation
* Use of aspirin in pregnancy prior to enrollment
* Known platelet disorder at time of enrollment
10 Years
60 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
March of Dimes
OTHER
Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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19F.887
Identifier Type: -
Identifier Source: org_study_id
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