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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

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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