Examining how aspirin metabolism relates to metabolic dysfunction in pregnant individuals at risk of preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between aspirin metabolism and markers of metabolic dysfunction in pregnant individuals who are at risk for preeclampsia. Participants will be those recommended aspirin therapy for preeclampsia prevention and will undergo various assessments, including a 2-hour oral glucose tolerance test (OGTT) and body composition measures. Additionally, the study will evaluate neonatal body composition and anthropometric data to understand the impacts of maternal metabolic dysfunction on newborns.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Tennessee Medical Center
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Jill M Maples, PhD
• Email: jmaples1@utmck.edu
• Phone: 865-305-9367

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.