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RecruitingNCT06802861

Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia

Sponsor

University of Tennessee Graduate School of Medicine

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

PregnancyPregnancy ComplicationsPreeclampsiaObesity and Obesity-related Medical ConditionsGestational DiabetesGestational Diabetes Mellitus in PregnancyPreeclampsia (PE)Preeclampsia (PE) RiskGestational Complications

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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

Locations(1)

University of Tennessee Medical Center

Knoxville, Tennessee, United States

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NCT06802861

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