Observational Study of Fetal Liver Ultrasound Radiomics to Detect Hyperinsulinemia in Pregnancies with Type 1 Diabetes Compared to Healthy Pregnancies

What this Trial Is About

This research aims to compare fetal liver ultrasound radiomic features between pregnancies complicated by type 1 diabetes and healthy pregnancies. It focuses on whether these ultrasound features are reproducible and if they differ due to maternal diabetes, which can cause fetal hyperinsulinemia leading to risks like macrosomia and neonatal complications. The study is a prospective observational pilot involving pregnant women with type 1 diabetes and healthy controls. Participants include 20 pregnant women with type 1 diabetes and 40 healthy pregnant women, all recruited at specific hospitals and clinics. Ultrasound examinations of the fetal liver will be conducted around 34 weeks of gestation to collect data for radiomics and machine learning analysis. The study aims to detect fetal hyperinsulinemia non-invasively and assess variability in ultrasound feature measurements. During the study, participants will undergo ultrasound scans to capture fetal liver images, along with monitoring of maternal glucose control through HbA1c and other glycemic indicators at several gestational points. Birth outcomes such as weight, neonatal hypoglycemia, respiratory complications, and NICU admissions will also be recorded. The study will evaluate ultrasound texture features and various neonatal and maternal health outcomes up to three months after birth.

Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics