Observational Study on Aspirin Metabolism and Preeclampsia Risk

This study is looking at the relationship between how your body processes aspirin and certain markers of metabolic health if you are pregnant and at risk for preeclampsia (a serious blood pressure condition during pregnancy). Researchers want to understand this connection better. You may be able to join if you are between 18 and 45 years old, pregnant, and your doctor has recommended aspirin to prevent preeclampsia. The study will measure specific substances in your body, like Hexadecadienoate and Salicylate (a component of aspirin), about an hour after you drink a sugary solution during a single visit between 14 and 20 weeks of pregnancy. The current status of this study is unclear, and it aims to include 50 participants.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to enroll 50 pregnant individuals.
What's involved
You would undergo a 2-hour oral glucose tolerance test (OGTT) for blood and urine collection, along with surveys, body composition measurements, and other assessments during a single study visit.
Compensation
Not stated in the trial record.
Follow-up
Measurements for the primary endpoints are taken at 60 minutes after glucose ingestion during a single study visit between 14-20 weeks gestational age.

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NCT06802861

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

Recruiting
Not specifiedAges 18–45Observational
University of Tennessee Graduate School of Medicine
~50 participants
Updated 2025-09-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hexadecadienoate (z score)
Measured over 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
+1 more outcome measured
Preeclampsia
Preeclampsia (PE)
Preeclampsia (PE) Risk
Obesity and Obesity-related Medical Conditions
Pregnancy
Pregnancy Complications
Gestational Diabetes
Gestational Diabetes Mellitus in Pregnancy
Gestational Complications
1 sites across 1 states
Tennessee1

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Eligibility criteria

Inclusion

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

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
  • 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)