An observational study in Pregnancy in Diabetic and Diabetes Mellitus, Type 1, sponsored by Turku University Hospital. Recruiting at 2 sites in Finland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Turku University Hospital · Observational
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:
Participants will undergo ultrasound examination to collect ultrasound data for the analyses.
Gestational diabetes is a growing health concern posing the neonate in the risk of adverse outcomes, such as macrosomia, cesarean delivery, hypoglycemia, respiratory morbidity, and need for neonatal intensive care. Most of these outcomes are either closely or causally related to fetal hyperinsulinemia, which is induced by maternal hyperglycemia. However, the accurate and non-invasive means of estimating fetal hyperinsulinemia are currently lacking.
Given that maternal diabetes and fetal hyperinsulinemia are associated with profound changes in fetal liver blood supply, biometry, metabolism, and lipid content, it was hypothesized that fetal hyperinsulinemia would be detectable by ultrasound using modern computer-aided technologies, i.e., radiomics and machine learning. In this prospective pilot study, the aim is to recruit 20 pregnant women with type I diabetes and compare them to 40 healthy controls. Patients with type 1 diabetes were chosen because their pregnancies are known to be associated with fetal hyperinsulinemia. Study subjects will be recruited at Turku University Hospital and the City of Turku maternity welfare clinics. It is assumed that radiomics analysis of fetal liver ultrasound pictures will indicate fetal hyperinsulinemia in pregnancies complicated by type 1 diabetes at 34 gestational weeks. Simultaneously, the inter- and intraobserver variability for fetal liver ultrasound radiomic features will be characterized.
In the future, non-invasive evaluation of fetal hyperinsulinemia could provide a useful tool in managing pregnancies complicated by maternal diabetes - either pre-gestational or gestational.
46 studies on the registry are indexed under Pregnancy in Diabetics; 16 are open to participants now.
This study's planned enrollment of 60 is below the median of 168 across 22 observational studies indexed under Pregnancy in Diabetics.
Browse Pregnancy in Diabetics studies →Turku University Hospital is the lead sponsor of 287 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women will be recruited at Turku University Hospital and Turku maternity welfare clinics during their routine pregnancy follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant woman with type 1 diabetes.
Pregnant women with uncomplicated pregnancy and normal oral glucose tolerance test (OGTT).
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 gestation
Birth weight in grams
Birth weight in grams as routinely measured after birth.
Time frame: After delivery, up to 24 hours
Birth weight centile
Birth weight adjusted for gestational age, fetal sex, and maternal parity.
Time frame: After delivery, up to 24 hours
Large for gestational age (LGA)
Birth weight above 90th centile
Time frame: After delivery, up to 24 hours
Interventricular septum (IVS) width
Fetal cardiac interventricular septum (IVS) width, measured at 34 gestational weeks
Time frame: 34+0 - 34+6 weeks of gestation
Number of pregnancies with neonatal hypoglycemia
Neonatal plasma glucose \< 2.6 mmol/L
Time frame: During initial hospitalization, up to one week of age
Rate of neonatal hypoglycemia treated with oral dextrose gel
Neonatal plasma glucose \< 2.6 mmol/L and treatment with oral dextrose gel
Time frame: During initial hospitalization, up to three weeks of age
Rate of neonatal hypoglycemia treated with intravenous (IV) glucose
Neonatal plasma glucose \< 2.6 mmol/L and treatment with IV glucose
Time frame: During initial hospitalization, up to three weeks of age
Length of treatment for neonatal hypoglycemia
Length of dextrose gel or IV glucose treatment (days)
Time frame: During initial hospitalization, up to three weeks of age
Number of neonates admitted to neonatal intensive care unit (NICU)
Neonatal admission to NICU
Time frame: During initial hospitalization, up to one week of age
Length of NICU admission
Length of NICU admission (days)
Time frame: During initial hospitalization, up to the age of three months
Number of pregnancies with neonatal respiratory complications related to maternal diabetes
Diagnosis of respiratory distress syndrome and/or transient tachypnea of the newborn
Time frame: During initial hospitalization, up to one week of age
Number of pregnancies with neonatal hyperbilirubinemia
Neonatal hyperbilirubinemia requiring phototherapy
Time frame: During initial hospitalization, up to two weeks of age
Maternal HbA1c concentration
Maternal HbA1c (mmol/mol)
Time frame: Close to 12, 21 and 32 weeks of gestation
Glucose management indicator (GMI)
HbA1c estimation based on continuous glucose monitoring (CGM) or flash glucose monitoring data
Time frame: Close to 12, 21 and 32 weeks of gestation
Time in glycemic range (TIR)
Time in glycemic range (TIR), if using CGM or flash monitoring
Time frame: Close to 12, 21 and 32 weeks of gestation
Time above glucose range
Time above glucose range, if using CGM or flash monitoring
Time frame: Close to 12, 21 and 32 weeks of gestation
Time below glucose range
Time below glucose range, if using CGM or flash monitoring
Time frame: Close to 12, 21 and 32 weeks of gestation
Plan to share: No — To ensure study subject anonymity the study data will not be published.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Mar 2026, 17 months after the start.
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