NCT06802861Recruiting
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
University of Tennessee Graduate School of Medicine
Start Date
1/1/2025
Completion Date
12/31/2028
Summary
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.
Eligibility Criteria
Age Range: 18 years to 45 years
Inclusion Criteria:
* Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist based on ACOG and USPSTF guidelines (1 high risk factor, 2+ moderate risk factors)
* Willingness to adhere to aspirin therapy
* Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
* Gestational age at enrollment \<16 weeks
* Ability to speak, read, and communicate via English
Exclusion Criteria:
* Type 2 Diabetes Mellitus
* Type 1 Diabetes Mellitus
* Current gestational diabetes mellitus
* Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
* Thrombophilia
* Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
* Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
* Current or recent use of steroids
* Current use of prophylactic or therapeutic anticoagulation
* Medical contraindication to aspirin therapy
* Molar pregnancy
* Renal disease
* Inability or unwillingness to give informed consent
* Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
Conditions
PreeclampsiaPreeclampsia (PE)Preeclampsia (PE) RiskObesity and Obesity-related Medical ConditionsPregnancyPregnancy ComplicationsGestational DiabetesGestational Diabetes Mellitus in PregnancyGestational Complications
Locations
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States