Evaluating fetal hyperinsulinemia using ultrasound radiomics
Official title: Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Run by Turku University Hospital · NCT06343974 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Turku University Hospital Government |
| Locations | 2 sites (Turku and 1 other locations) |
| Status | Recruiting |
| Started | October 11, 2024 |
| Main results expected | March 31, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT06343974 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women aged 18-45 with type 1 diabetes planning to deliver at Turku University Hospital.
✕Probably not a fit
Patients with major fetal anomalies, significant growth restrictions, or other serious maternal conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of using ultrasound radiomics is innovative, similar studies have not been widely reported, making this a novel investigation.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.