NCT06802861 Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
| NCT ID | NCT06802861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tennessee Graduate School of Medicine |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-01-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06802861 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06802861 currently recruiting?
Yes, NCT06802861 is actively recruiting participants. Contact the research team at jmaples1@utmck.edu for enrollment information.
Where is the NCT06802861 trial being conducted?
This trial is being conducted at Knoxville, United States.
Who is sponsoring the NCT06802861 clinical trial?
NCT06802861 is sponsored by University of Tennessee Graduate School of Medicine. The trial plans to enroll 50 participants.