Examining how aspirin metabolism relates to metabolic dysfunction in pregnant individuals at risk of preeclampsia
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
This study is trying to see how the way pregnant people process aspirin relates to their metabolic health and the health of their babies, especially for those at risk of preeclampsia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Tennessee Graduate School of Medicine Academic / other |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT06802861 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between aspirin metabolism and markers of metabolic dysfunction in pregnant individuals who are at risk for preeclampsia. Participants will be those recommended aspirin therapy for preeclampsia prevention and will undergo various assessments, including a 2-hour oral glucose tolerance test (OGTT) and body composition measures. Additionally, the study will evaluate neonatal body composition and anthropometric data to understand the impacts of maternal metabolic dysfunction on newborns.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals under 16 weeks of gestation who are recommended aspirin therapy for preeclampsia prevention and are willing to participate in the required assessments.
Not a fit: Patients with type 1 or type 2 diabetes, gestational diabetes, or certain bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how aspirin therapy may influence metabolic health during pregnancy, potentially improving outcomes for mothers and their infants.
How similar studies have performed: While there is ongoing research into aspirin's role in pregnancy, this specific focus on metabolic dysfunction and its relationship to preeclampsia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Knoxville, Tennessee
- University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Jill M Maples, PhD
- Email: jmaples1@utmck.edu
- Phone: 865-305-9367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.