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Идёт набор NCT06784674

Maternal Abdominal Morphology Assessment

— Наблюдательное Pregnancy Related Infant Development Pancreas Diabetes

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
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Pregnancy Related, Infant Development, Pancreas, Diabetes. Базовые параметры: 18 лет — 54 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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Официальное название

Diabetes Prediction During Pregnancy Using Pancreas MRI

Обзор

Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes. The MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.

Подробное описание

As pancreas size is thought to reflect pancreatic insulin production and/or islet mass, monitoring pancreas size during and after pregnancy may advance the investigators' understanding of gestational diabetes mellitus (GDM) incidence and progression. Information on pancreas size changes during pregnancy, typical fetal pancreatic development, the relationship between pancreas size and GDM risk, and the relationship between pancreas size and neonatal hypoglycemia are largely unknown. Through this project, magnetic resonance imaging (MRI) will be used to measure changes in pancreas size during pregnancy and the effect of maternal diabetes on these measures.

This prospective cohort study is observational and will include up to 87 pregnant women who are between 18-54 years old. Study visits will take place at approximately 15-18 weeks gestation, 24-28 weeks gestation, 34-38 weeks gestation, and 1 year-1 year and 2 months postpartum. At each study visit, participants will self-report their height and weight, have their blood pressure measured, have their blood drawn, have an HbA1c finger stick test, participate in oral glucose tolerance testing (OGTT), complete an MRI scan, and undergo continuous glucose monitoring (CGM).

Вмешательства

  • Другое No intervention
    Observational study

Первичные конечные точки

  • Maternal Pancreatic Volume [Срок оценки: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.]
  • Fetal Pancreatic Volume [Срок оценки: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation.]
Вторичные конечные точки (2)
  • Plasma Insulin [Срок оценки: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.]
  • Plasma Glucose [Срок оценки: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.]

Критерии участия

Критерии включения

  • Pregnant women, with a singleton gestation
  • Age 18 - 54 years at screening
  • Gestational age < 14 weeks
  • Willing to commit to 1 year postpartum follow up
  • Planning to remain in geographical vicinity of Austin for 1 year after delivery

Критерии исключения

  • Presence of any mechanically or magnetically activated implants
  • Claustrophobia
  • Other contraindication for MRI
  • BMI ≥ 38.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Dell Medical School Health Discovery Building — Austin

Идентификаторы

NCT: NCT06784674 · STUDY00005491

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗