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Идёт набор NCT06802861

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Preeclampsia, Preeclampsia (PE), Preeclampsia (PE) Risk, Obesity and Obesity-related Medical Conditions. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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

Первичные конечные точки

  • Hexadecadienoate (z score) [Срок оценки: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age]
  • Salicylate (z score) [Срок оценки: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age]
Вторичные конечные точки (12)
  • Urinary thromboxane B2 level (pg/mg creat) [Срок оценки: 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) [Срок оценки: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age]
  • 1 Hour Salicylate level (ug/mL) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age]
  • 1 Hour PFA-100 epinephrine closure time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Measured at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Respiratory Quotient [Срок оценки: Measured at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Carbohydrate Oxidation Rate [Срок оценки: Measured at the start of a single study visit between 14-20 weeks gestational age]
  • Fasting Lipid Oxidation Rate [Срок оценки: Measured at the start of a single study visit between 14-20 weeks gestational age]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Tennessee Medical Center — Knoxville

Идентификаторы

NCT: NCT06802861 · 5316

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗