RecruitingNCT06343974

Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics

Sponsor

Turku University Hospital

Enrollment

60 participants

Start Date

Oct 11, 2024

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus, Type 1 Pregnancy in Diabetic

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

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 Criteria8

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