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

University of Tennessee Graduate School of Medicine

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06802861

5316

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Pregnant individuals at risk for preecampsia