Actively Recruiting
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
Led by University of Tennessee Graduate School of Medicine ยท Updated on 2025-09-10
50
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between how aspirin is processed in the body and markers of metabolic dysfunction in pregnant individuals at risk for preeclampsia. The study focuses on understanding these connections during pregnancy, particularly in those recommended aspirin for preeclampsia prevention based on specific risk factors. Participants will undergo a single study visit between 14 and 20 weeks of gestation where they will ingest 75 grams of glucose. During this visit, various blood and urine samples will be collected to measure aspirin metabolites and metabolic markers. Additional assessments include indirect calorimetry, body composition measurements, surveys, and neonatal measurements. The study measures include glucose tolerance, salicylate levels, thromboxane levels, insulin resistance, and lipid profiles. Throughout the study visit, researchers will monitor metabolic responses and aspirin metabolism at specific time points after glucose ingestion. Participants are expected to fast before the visit and will be assessed for multiple metabolic and biochemical markers to evaluate their relationship with aspirin metabolism. The total participation involves a single visit with detailed sample collection and metabolic assessments, with safety and compliance monitored by the research team.
CONDITIONS
Brief Title
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 follow aspirin therapy
- Willingness to undergo a 2-hour oral glucose tolerance test and related assessments
- Gestational age less than 16 weeks at enrollment
- Ability to speak, read, and communicate in English
You will not qualify if you...
- Type 2 Diabetes Mellitus
- Type 1 Diabetes Mellitus
- Current gestational diabetes mellitus
- Active platelet disorder or bleeding problems
- Thrombophilia
- Use of NSAIDs for other reasons
- Use of immune-modulating agents or biologics
- Current or recent steroid use
- Use of blood thinners
- Medical reasons preventing aspirin use
- Molar pregnancy
- Kidney disease
- Inability or unwillingness to give informed consent
- Psychiatric illness or social issues limiting study compliance as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a single study visit involving a 2-hour oral glucose tolerance test and related assessments of aspirin metabolism and metabolic markers.
1 visit (in-person)
Duration - Up to delivery
Participants are observed for metabolic and aspirin metabolism markers following the diagnostic evaluation.
No scheduled visits; participants are monitored through routine care
Trial Site Locations
Total: 1 location
1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
J
Jill M Maples, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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