Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy
NCT ID: NCT04645004
Last Updated: 2024-04-18
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
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2020-12-29
2024-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Aspirin
81mg aspirin daily
Aspirin 81Mg Non-enteric coated Tab
one tab daily
Interventions
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Aspirin 81Mg Non-enteric coated Tab
one tab daily
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Plan to take 81mg aspirin due to high risk history (below), but not yet initiated
* ≥1 risk factor:
* Chronic hypertension
* Type I or II diabetes
* Previous preeclampsia
* Renal disease
* Autoimmune disease (SLE) OR
≥2 risk factor:
* Nulliparity
* IVF pregnancy
* Black race or socioeconomic disadvantaged
* BMI\>30
* Prior adverse pregnancy outcome
Exclusion Criteria
* Current or planned use of any other anticoagulation
* Current need for dialysis
* Use of aspirin therapy prior to enrollment in the current pregnancy
* Thrombocytopenia (\<150)
* Other known platelet disorder/thrombophilia at enrollment
13 Years
55 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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Principal Investigators
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Rupsa C Boelig, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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20F.911
Identifier Type: -
Identifier Source: org_study_id
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