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Recruiting NCT06802861

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

— Observational Preeclampsia Preeclampsia (PE) Preeclampsia (PE) Risk Obesity and Obesity-related Medical Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Urinary thromboxane B2 level (pg/mg creat) [Time frame: 60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age]
  • Fasting Salicylate level (ug/mL) [Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age]
  • 1 Hour Salicylate level (ug/mL) [Time frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age]
  • 2 Hour Salicylate level (ug/mL) [Time frame: 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age]
  • Fasting PFA-100 epinephrine closure time [Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age]
  • 1 Hour PFA-100 epinephrine closure time [Time frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age]
  • 2 Hour PFA-100 epinephrine closure time [Time frame: 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age]
  • Homeostatic Model Assessment for Insulin Resistance [Time frame: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Resting Metabolic Rate [Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Respiratory Quotient [Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Carbohydrate Oxidation Rate [Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Lipid Oxidation Rate [Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Tennessee Medical Center — Knoxville

Identifiers

NCT: NCT06802861 · 5316

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗