Actively Recruiting
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Led by Turku University Hospital · Updated on 2025-11-28
60
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare fetal liver ultrasound radiomic features between pregnancies complicated by type 1 diabetes and healthy pregnancies. It focuses on whether these ultrasound features are reproducible and if they differ due to maternal diabetes, which can cause fetal hyperinsulinemia leading to risks like macrosomia and neonatal complications. The study is a prospective observational pilot involving pregnant women with type 1 diabetes and healthy controls. Participants include 20 pregnant women with type 1 diabetes and 40 healthy pregnant women, all recruited at specific hospitals and clinics. Ultrasound examinations of the fetal liver will be conducted around 34 weeks of gestation to collect data for radiomics and machine learning analysis. The study aims to detect fetal hyperinsulinemia non-invasively and assess variability in ultrasound feature measurements. During the study, participants will undergo ultrasound scans to capture fetal liver images, along with monitoring of maternal glucose control through HbA1c and other glycemic indicators at several gestational points. Birth outcomes such as weight, neonatal hypoglycemia, respiratory complications, and NICU admissions will also be recorded. The study will evaluate ultrasound texture features and various neonatal and maternal health outcomes up to three months after birth.
CONDITIONS
Brief Title
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18-45 years
- Able to give informed consent
- Singleton pregnancy
- Planning to deliver at Turku University Hospital
- Maternal BMI under 40
- Gestational age confirmed by first trimester ultrasound
- Normal oral glucose tolerance test (OGTT) at 24-28 weeks in control participants
You will not qualify if you...
- Major fetal chromosomal, genetic, or structural anomaly
- Fetal growth restriction or birth weight below 10th centile
- Birth weight above 90th centile or polyhydramnios in controls
- Non-reassuring fetal status requiring immediate treatment or intrauterine fetal demise
- Verified fetal infection such as cytomegalovirus, toxoplasma, hepatitis B or C
- Placenta accreta spectrum disorder
- Major maternal medical conditions requiring systemic pharmacological treatment, except non-severe hypertension, hypothyroidism, asthma, mild psychiatric disorders
- Alcohol, tobacco use, or substance abuse during pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 1 week around 34 weeks of gestation
Participants undergo fetal liver ultrasound imaging to evaluate fetal hyperinsulinemia using radiomics and machine learning at 34 weeks of gestation.
1 ultrasound visit (in-person) between 34+0 and 34+6 weeks of gestation
Duration - From delivery up to 3 months post-delivery
Participants and their newborns are monitored for neonatal outcomes including birth weight, hypoglycemia, respiratory complications, and NICU admissions during the initial hospitalization and up to three months after birth.
Follow-up assessments during initial hospitalization and up to 3 months after delivery
Trial Site Locations
Total: 2 locations
1
Turku University Hospital
Turku, Finland
Actively Recruiting
2
Turku University Hospital
Turku, Finland
Actively Recruiting
Research Team
M
Mikael Huhtala, M.D., Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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