Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
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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: Pregnancy in Diabetic, Diabetes Mellitus, Type 1. 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
- Финляндия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls. The main questions it aims to answer are: * Are fetal liver ultrasound radiomic features reproducible? * Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls? Participants will undergo ultrasound examination to collect ultrasound data for the analyses.
Подробное описание
Gestational diabetes is a growing health concern posing the neonate in the risk of adverse outcomes, such as macrosomia, cesarean delivery, hypoglycemia, respiratory morbidity, and need for neonatal intensive care. Most of these outcomes are either closely or causally related to fetal hyperinsulinemia, which is induced by maternal hyperglycemia. However, the accurate and non-invasive means of estimating fetal hyperinsulinemia are currently lacking.
Given that maternal diabetes and fetal hyperinsulinemia are associated with profound changes in fetal liver blood supply, biometry, metabolism, and lipid content, it was hypothesized that fetal hyperinsulinemia would be detectable by ultrasound using modern computer-aided technologies, i.e., radiomics and machine learning. In this prospective pilot study, the aim is to recruit 20 pregnant women with type I diabetes and compare them to 40 healthy controls. Patients with type 1 diabetes were chosen because their pregnancies are known to be associated with fetal hyperinsulinemia. Study subjects will be recruited at Turku University Hospital and the City of Turku maternity welfare clinics. It is assumed that radiomics analysis of fetal liver ultrasound pictures will indicate fetal hyperinsulinemia in pregnancies complicated by type 1 diabetes at 34 gestational weeks. Simultaneously, the inter- and intraobserver variability for fetal liver ultrasound radiomic features will be characterized.
In the future, non-invasive evaluation of fetal hyperinsulinemia could provide a useful tool in managing pregnancies complicated by maternal diabetes - either pre-gestational or gestational.
Первичные конечные точки
- Fetal liver ultrasound texture [Срок оценки: 34+0 - 34+6 weeks of gestation]
Вторичные конечные точки (12)
- Birth weight in grams [Срок оценки: After delivery, up to 24 hours]
- Birth weight centile [Срок оценки: After delivery, up to 24 hours]
- Large for gestational age (LGA) [Срок оценки: After delivery, up to 24 hours]
- Interventricular septum (IVS) width [Срок оценки: 34+0 - 34+6 weeks of gestation]
- Number of pregnancies with neonatal hypoglycemia [Срок оценки: During initial hospitalization, up to one week of age]
- Rate of neonatal hypoglycemia treated with oral dextrose gel [Срок оценки: During initial hospitalization, up to three weeks of age]
- Rate of neonatal hypoglycemia treated with intravenous (IV) glucose [Срок оценки: During initial hospitalization, up to three weeks of age]
- Length of treatment for neonatal hypoglycemia [Срок оценки: During initial hospitalization, up to three weeks of age]
- Number of neonates admitted to neonatal intensive care unit (NICU) [Срок оценки: During initial hospitalization, up to one week of age]
- Length of NICU admission [Срок оценки: During initial hospitalization, up to the age of three months]
- Number of pregnancies with neonatal respiratory complications related to maternal diabetes [Срок оценки: During initial hospitalization, up to one week of age]
- Number of pregnancies with neonatal hyperbilirubinemia [Срок оценки: During initial hospitalization, up to two weeks of age]
Критерии участия
Критерии включения
- Age between 18-45 years
- Capable to give an informed consent
- Singleton pregnancy
- Planning to deliver in Turku University Hospital
- Maternal BMI < 40
- Gestational age should be confirmed by first trimester ultrasound
- Normal oral glucose tolerance test (OGTT) at 24-28 gestational weeks in controls
Критерии исключения
- Major fetal chromosomal, genetic, or structural anomaly
- Fetal growth restriction, or birth weight < 10th centile
- Birth weight > 90th centile or polyhydramnios in the controls
- Non-reassuring fetal status requiring immediate treatment, or intrauterine fetal demise
- Verified fetal infection (e.g. cytomegalovirus, toxoplasma, hepatitis B and C), excluding bacterial infection due to intrapartum chorioamnionitis
- Placenta accreta spectrum disorder
- Major maternal medical condition requiring systemic pharmacological treatment, other than non-severe hypertension, hypothyroidism, asthma, mild psychiatric disorders, etc.
- Alcohol or tobacco use, or substance abuse in pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Финляндия · 2 центра
- Turku University Hospital — Turku
- Turku University Hospital — Turku
Идентификаторы
NCT: NCT06343974 · 0843