NCT06343974 Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
| NCT ID | NCT06343974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | Pregnancy in Diabetic |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-10-11 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mikael Huhtala, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Turku University Hospital
Frequently Asked Questions
Who can join the NCT06343974 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pregnancy in Diabetic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06343974 currently recruiting?
Yes, NCT06343974 is actively recruiting participants. Contact the research team at misahu@utu.fi for enrollment information.
Where is the NCT06343974 trial being conducted?
This trial is being conducted at Turku, Finland, Turku, Finland.
Who is sponsoring the NCT06343974 clinical trial?
NCT06343974 is sponsored by Turku University Hospital. The principal investigator is Mikael Huhtala, M.D., Ph.D. at Turku University Hospital. The trial plans to enroll 60 participants.