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

Launched by UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes aspirin and how that relates to certain health markers in pregnant women who are at risk for a condition called preeclampsia. Preeclampsia can cause serious complications during pregnancy, so understanding how aspirin may help is important. Researchers will also look at how the mother’s health affects the baby’s growth and body composition after birth.

To participate in this study, women must be pregnant and under 16 weeks gestation, and their doctor must have recommended aspirin to help prevent preeclampsia. Participants should be willing to take aspirin and complete some tests, like a blood sugar test and surveys. However, certain conditions like diabetes or bleeding disorders would exclude someone from joining the study. If eligible, participants can expect to provide health information, undergo various assessments, and help researchers learn more about the effects of aspirin during pregnancy.

Gender

FEMALE

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