Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy in Diabetic, Diabetes Mellitus, Type 1. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Primary outcome measures
- Fetal liver ultrasound texture [Time frame: 34+0 - 34+6 weeks of gestation]
Secondary outcome measures (12)
- Birth weight in grams [Time frame: After delivery, up to 24 hours]
- Birth weight centile [Time frame: After delivery, up to 24 hours]
- Large for gestational age (LGA) [Time frame: After delivery, up to 24 hours]
- Interventricular septum (IVS) width [Time frame: 34+0 - 34+6 weeks of gestation]
- Number of pregnancies with neonatal hypoglycemia [Time frame: During initial hospitalization, up to one week of age]
- Rate of neonatal hypoglycemia treated with oral dextrose gel [Time frame: During initial hospitalization, up to three weeks of age]
- Rate of neonatal hypoglycemia treated with intravenous (IV) glucose [Time frame: During initial hospitalization, up to three weeks of age]
- Length of treatment for neonatal hypoglycemia [Time frame: During initial hospitalization, up to three weeks of age]
- Number of neonates admitted to neonatal intensive care unit (NICU) [Time frame: During initial hospitalization, up to one week of age]
- Length of NICU admission [Time frame: During initial hospitalization, up to the age of three months]
- Number of pregnancies with neonatal respiratory complications related to maternal diabetes [Time frame: During initial hospitalization, up to one week of age]
- Number of pregnancies with neonatal hyperbilirubinemia [Time frame: During initial hospitalization, up to two weeks of age]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Finland · 2 centers
- Turku University Hospital — Turku
- Turku University Hospital — Turku
Identifiers
NCT: NCT06343974 · 0843