Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorTurku University Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
Age between 18-45 years
Capable to give an informed consent
Singleton pregnancy
Planning to deliver in Turku University Hospital
Disqualifiers
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
Trial population
Pregnant women will be recruited at Turku University Hospital and Turku maternity welfare clinics during their routine pregnancy follow-up.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Type 1 diabetes
Group B: Healthy controls
Trial outcomes
Primary outcomes
1
Fetal liver ultrasound texture
Fetal liver ultrasound texture is the collection of radiomic features that are extracted from the fetal liver ultrasound picture. The ultrasound pictures are acquired using transabdominal ultrasound. The radiomic features are extracted using conventional radiomics libraries e.g. pyradiomics.
Time frame
34+0 - 34+6 weeks of gestationSecondary outcomes
1
Birth weight in grams
Birth weight in grams as routinely measured after birth.
Time frame
After delivery, up to 24 hours2
Birth weight centile
Birth weight adjusted for gestational age, fetal sex, and maternal parity.
Time frame
After delivery, up to 24 hours3
Large for gestational age (LGA)
Birth weight above 90th centile
Time frame
After delivery, up to 24 hours4
Interventricular septum (IVS) width
Fetal cardiac interventricular septum (IVS) width, measured at 34 gestational weeks
Time frame
34+0 - 34+6 weeks of gestationSponsors and contacts
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Source ClinicalTrials.gov