Recruiting
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.
ClinicalTrials.gov IDNCT06802861
PhaseNot Applicable
Enrollment50
SponsorUniversity of Tennessee Graduate School of Medicine
Age18 Years – 45 Years
SexFEMALE
Conditions studied
Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions, Pregnancy, Pregnancy Complications, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Gestational Complications
About this study
This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.
Primary outcomes
- Hexadecadienoate (z score) (60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age)
- Salicylate (z score) (60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age)
Eligibility information
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
Study locations
- University of Tennessee Medical Center, Knoxville, Tennessee 37920 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-03.