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

Last updated: January 24, 2025
Sponsor: University of Tennessee Graduate School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Pregnancy

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT06802861
5316
  • Ages 18-45
  • Female

Study 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. Further, we will add an exploratory outcome to evaluate the neonatal body composition and anthropometric data to better understand neonatal impacts of maternal metabolic dysfunction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist basedon 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 tosurvey collection, indirect calorimetry, body composition measures, neonatalmeasures, etc.

  • Gestational age at enrollment <16 weeks

  • Ability to speak, read, and communicate via English

Exclusion

Exclusion Criteria:

  • Type 2 Diabetes Mellitus

  • Type 1 Diabetes Mellitus

  • Current gestational diabetes mellitus

  • Current/active platelet disorder or bleeding diathesis (thrombocytopenia of anyetiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenicpurpura/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 withstudy requirements, as determined by the principal investigators

Study Design

Total Participants: 50
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

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