Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Perso… (NCT06802861) | Clinical Trial Compass
RecruitingNot Applicable
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
United States50 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Hexadecadienoate (z score)
Timeframe: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
2
Salicylate (z score)
Timeframe: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Trial details
NCT IDNCT06802861
SponsorUniversity of Tennessee Graduate School of Medicine