Recruiting

Aspirin

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT06802861

Conditions

Preeclampsia

Preeclampsia (PE)

Preeclampsia (PE) Risk

Obesity and Obesity-related Medical Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Preeclampsia

Preeclampsia (PE)

Preeclampsia (PE) Risk

Obesity and Obesity-related Medical Conditions

Pregnancy

Study ID

NCT06802861

Start date

Jan 1, 2025

Status verified date

Jan, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant individuals at risk for preecampsia

Primary outcome measure

  • Hexadecadienoate (z score) [ Time Frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age ]
  • Salicylate (z score) [ Time Frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age ]

Central Contacts and Locations

Central contacts

Jill M Maples, PhD

865-305-9367jmaples1@utmck.edu

Locations

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Rebecca Purvis, MD

rpurvis@utmck.edu

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Sep 10, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2025-09-10.