Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics

Turku University Hospital60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy in Diabetic

Outcomes

Primary Outcomes

Fetal liver ultrasound texture

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.

Time frame: 34+0 - 34+6 weeks of gestation

Secondary Outcomes

Birth weight in grams

Birth weight in grams as routinely measured after birth.

Time frame: After delivery, up to 24 hours

Birth weight centile

Birth weight adjusted for gestational age, fetal sex, and maternal parity.

Time frame: After delivery, up to 24 hours

Large for gestational age (LGA)

Birth weight above 90th centile

Time frame: After delivery, up to 24 hours

Interventricular septum (IVS) width

Fetal cardiac interventricular septum (IVS) width, measured at 34 gestational weeks

Time frame: 34+0 - 34+6 weeks of gestation

Number of pregnancies with neonatal hypoglycemia

Neonatal plasma glucose \< 2.6 mmol/L

Time frame: During initial hospitalization, up to one week of age

Rate of neonatal hypoglycemia treated with oral dextrose gel

Neonatal plasma glucose \< 2.6 mmol/L and treatment with oral dextrose gel

Time frame: During initial hospitalization, up to three weeks of age

Rate of neonatal hypoglycemia treated with intravenous (IV) glucose

Neonatal plasma glucose \< 2.6 mmol/L and treatment with IV glucose

Time frame: During initial hospitalization, up to three weeks of age

Length of treatment for neonatal hypoglycemia

Length of dextrose gel or IV glucose treatment (days)

Time frame: During initial hospitalization, up to three weeks of age

Number of neonates admitted to neonatal intensive care unit (NICU)

Neonatal admission to NICU

Time frame: During initial hospitalization, up to one week of age

Length of NICU admission

Length of NICU admission (days)

Time frame: During initial hospitalization, up to the age of three months

Number of pregnancies with neonatal respiratory complications related to maternal diabetes

Diagnosis of respiratory distress syndrome and/or transient tachypnea of the newborn

Time frame: During initial hospitalization, up to one week of age

Number of pregnancies with neonatal hyperbilirubinemia

Neonatal hyperbilirubinemia requiring phototherapy

Time frame: During initial hospitalization, up to two weeks of age

Maternal HbA1c concentration

Maternal HbA1c (mmol/mol)