RECRUITING

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

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Conditions

PreeclampsiaPreeclampsia (PE)Preeclampsia (PE) RiskObesity and Obesity-related Medical ConditionsPregnancyPregnancy ComplicationsGestational DiabetesGestational Diabetes Mellitus in PregnancyGestational Complicationsmetabolic dysfunctionmaternal obesitymaternal insulin resistanceaspirin metabolismGDMsubstrate oxidationgestational glucose intolerance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

Official Title

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

Quick Facts

Study Start:2025-01-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06802861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Willingness to adhere to aspirin therapy
  3. * Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
  4. * Gestational age at enrollment \<16 weeks
  5. * Ability to speak, read, and communicate via English
  1. * Type 2 Diabetes Mellitus
  2. * Type 1 Diabetes Mellitus
  3. * Current gestational diabetes mellitus
  4. * Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
  5. * Thrombophilia
  6. * Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
  7. * Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
  8. * Current or recent use of steroids
  9. * Current use of prophylactic or therapeutic anticoagulation
  10. * Medical contraindication to aspirin therapy
  11. * Molar pregnancy
  12. * Renal disease
  13. * Inability or unwillingness to give informed consent
  14. * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators

Contacts and Locations

Study Contact

Jill M Maples, PhD
CONTACT
865-305-9367
jmaples1@utmck.edu

Study Locations (Sites)

University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States

Collaborators and Investigators

Sponsor: University of Tennessee Graduate School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • metabolic dysfunction
  • gestational diabetes
  • pregnancy
  • maternal obesity
  • maternal insulin resistance
  • aspirin metabolism
  • GDM
  • substrate oxidation
  • gestational glucose intolerance

Additional Relevant MeSH Terms

  • Preeclampsia
  • Preeclampsia (PE)
  • Preeclampsia (PE) Risk
  • Obesity and Obesity-related Medical Conditions
  • Pregnancy
  • Pregnancy Complications
  • Gestational Diabetes
  • Gestational Diabetes Mellitus in Pregnancy
  • Gestational Complications