Evaluating fetal hyperinsulinemia using ultrasound radiomics
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Turku University Hospital · NCT06343974
This study is testing if special ultrasound images can help tell if babies are at risk for high insulin levels when their mothers have type 1 diabetes, compared to healthy pregnancies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Turku University Hospital (other gov) |
| Locations | 2 sites (Turku and 1 other locations) |
| Trial ID | NCT06343974 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare fetal liver ultrasound radiomic features between pregnancies complicated by type 1 diabetes and healthy controls. It will assess the reproducibility of these features and investigate differences in ultrasound data collected from participants. The study will involve 20 pregnant women with type 1 diabetes and 40 healthy controls, with ultrasound examinations conducted at 34 weeks of gestation. The goal is to determine if non-invasive ultrasound techniques can effectively indicate fetal hyperinsulinemia associated with maternal diabetes.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18-45 with type 1 diabetes planning to deliver at Turku University Hospital.
Not a fit: Patients with major fetal anomalies, significant growth restrictions, or other serious maternal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection of fetal hyperinsulinemia, potentially improving outcomes for infants born to mothers with diabetes.
How similar studies have performed: While the approach of using ultrasound radiomics is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Turku and 1 other locations
- Turku University Hospital — Turku, Finland (RECRUITING)
- Turku University Hospital — Turku, Finland (RECRUITING)
Study contacts
- Principal investigator: Mikael Huhtala, M.D., Ph.D. — Turku University Hospital
- Study coordinator: Mikael Huhtala, M.D., Ph.D.
- Email: misahu@utu.fi
- Phone: +35823130000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy in Diabetic, Diabetes Mellitus, Type 1, ultrasonography, fetus, radiomics, hyperinsulinemia, liver, pregnancy