Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06802861

Recruiting nowNot applicableObservational

What this study is about

This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionPreeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions, Pregnancy, Pregnancy Complications, Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Gestational Complications

Full registry criteria

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

Treatments and study arms

The registry does not list a named intervention.

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

Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)

Salicylate (z score)60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Tennessee Medical Center🇺🇸 Knoxville, Tennessee, United States
Rebecca Purvis, MDContact