Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fetal liver ultrasound texture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fetal liver ultrasound texture
时间窗: 34+0 - 34+6 weeks of gestation
Fetal liver ultrasound texture is the collection of radiomic features that are extracted from the fetal liver ultrasound picture. The ultrasound pictures are acquired using transabdominal ultrasound. The radiomic features are extracted using conventional radiomics libraries e.g. pyradiomics.
次要结局
- Maternal HbA1c concentration(Close to 12, 21 and 32 weeks of gestation)
- Time below glucose range(Close to 12, 21 and 32 weeks of gestation)
- Birth weight in grams(After delivery, up to 24 hours)
- Number of pregnancies with neonatal respiratory complications related to maternal diabetes(During initial hospitalization, up to one week of age)
- Number of pregnancies with neonatal hyperbilirubinemia(During initial hospitalization, up to two weeks of age)
- Time in glycemic range (TIR)(Close to 12, 21 and 32 weeks of gestation)
- Large for gestational age (LGA)(After delivery, up to 24 hours)
- Interventricular septum (IVS) width(34+0 - 34+6 weeks of gestation)
- Rate of neonatal hypoglycemia treated with intravenous (IV) glucose(During initial hospitalization, up to three weeks of age)
- Number of neonates admitted to neonatal intensive care unit (NICU)(During initial hospitalization, up to one week of age)
- Length of NICU admission(During initial hospitalization, up to the age of three months)
- Glucose management indicator (GMI)(Close to 12, 21 and 32 weeks of gestation)
- Birth weight centile(After delivery, up to 24 hours)
- Rate of neonatal hypoglycemia treated with oral dextrose gel(During initial hospitalization, up to three weeks of age)
- Length of treatment for neonatal hypoglycemia(During initial hospitalization, up to three weeks of age)
- Number of pregnancies with neonatal hypoglycemia(During initial hospitalization, up to one week of age)
- Time above glucose range(Close to 12, 21 and 32 weeks of gestation)
研究者
Mikael Huhtala
Physician, MD, PhD
Turku University Hospital