Pregnancy in DiabeticNCT06343974
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
An observational study of Pregnancy in Diabetic and Diabetes Mellitus, Type 1, run by Turku University Hospital at 2 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Diabetic, Diabetes Mellitus, Type 1
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 2 sitesFinland
- Study dates
- 11 Oct 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women will be recruited at Turku University Hospital and Turku maternity welfare clinics during their routine pregnancy follow-up.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Turku University Hospital
Turku
Mikael Huhtala, M.D., Ph.D., misahu@utu.fi
- Recruiting
Turku University Hospital
Turku
Mikael Huhtala, MD, PhD
Mikae Huhtala, MD, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Pregnancy in Diabetic, Diabetes Mellitus, Type 1
- Keywords
- ultrasonography, fetus, radiomics, hyperinsulinemia, liver, pregnancy
- Medical subject headings
- Pregnancy in Diabetics, Diabetes Mellitus, Type 1, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Pregnant woman with type 1 diabetes. | |
| Healthy controls | Pregnant women with uncomplicated pregnancy and normal oral glucose tolerance test (OGTT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34+0 - 34+6 weeks of gestation
Secondary outcomes (17)
Birth weight in grams
Birth weight in grams as routinely measured after birth.
Measured: After delivery, up to 24 hours
Birth weight centile
Birth weight adjusted for gestational age, fetal sex, and maternal parity.
Measured: After delivery, up to 24 hours
Large for gestational age (LGA)
Birth weight above 90th centile
Measured: After delivery, up to 24 hours
Interventricular septum (IVS) width
Fetal cardiac interventricular septum (IVS) width, measured at 34 gestational weeks
Measured: 34+0 - 34+6 weeks of gestation
Number of pregnancies with neonatal hypoglycemia
Neonatal plasma glucose < 2.6 mmol/L
Measured: 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
Measured: 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
Measured: During initial hospitalization, up to three weeks of age
Length of treatment for neonatal hypoglycemia
Length of dextrose gel or IV glucose treatment (days)
Measured: During initial hospitalization, up to three weeks of age
Number of neonates admitted to neonatal intensive care unit (NICU)
Neonatal admission to NICU
Measured: During initial hospitalization, up to one week of age
Length of NICU admission
Length of NICU admission (days)
Measured: 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
Measured: During initial hospitalization, up to one week of age
Number of pregnancies with neonatal hyperbilirubinemia
Neonatal hyperbilirubinemia requiring phototherapy
Measured: During initial hospitalization, up to two weeks of age
Maternal HbA1c concentration
Maternal HbA1c (mmol/mol)
Measured: 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
Measured: 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
Measured: Close to 12, 21 and 32 weeks of gestation
Time above glucose range
Time above glucose range, if using CGM or flash monitoring
Measured: Close to 12, 21 and 32 weeks of gestation
Time below glucose range
Time below glucose range, if using CGM or flash monitoring
Measured: Close to 12, 21 and 32 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start11 Oct 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in DiabeticStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mikael Huhtala, Turku University Hospital
- Investigators
- Mikael Huhtala, M.D., Ph.D., Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343974
- Sponsor's protocol ID
- 0843
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure study subject anonymity the study data will not be published.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
- ClinicalTrials.gov ID
- NCT06343974
- Acronym / sponsor ID
- 0843
- Conditions
- Pregnancy in Diabetic, Diabetes Mellitus, Type 1
- Keywords
- ultrasonography, fetus, radiomics, hyperinsulinemia, liver, pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | –Pregnant woman with type 1 diabetes. |
| Healthy controls | – | –Pregnant women with uncomplicated pregnancy and normal oral glucose tolerance test (OGTT). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women will be recruited at Turku University Hospital and Turku maternity welfare clinics during their routine pregnancy follow-up.
Key inclusion criteria (7 listed)
- Age between 18-45 years
- Capable to give an informed consent
- Singleton pregnancy
- Planning to deliver in Turku University Hospital
- Maternal BMI < 40
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal liver ultrasound texture
Time frame: 34+0 - 34+6 weeks of gestation
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.
17 secondary outcomes
Birth weight in grams
Time frame: After delivery, up to 24 hours
Birth weight centile
Time frame: After delivery, up to 24 hours
Large for gestational age (LGA)
Time frame: After delivery, up to 24 hours
Interventricular septum (IVS) width
Time frame: 34+0 - 34+6 weeks of gestation
Number of pregnancies with neonatal hypoglycemia
Time frame: During initial hospitalization, up to one week of age
Rate of neonatal hypoglycemia treated with oral dextrose gel
Time frame: During initial hospitalization, up to three weeks of age
Rate of neonatal hypoglycemia treated with intravenous (IV) glucose
Time frame: During initial hospitalization, up to three weeks of age
Length of treatment for neonatal hypoglycemia
Time frame: During initial hospitalization, up to three weeks of age
Number of neonates admitted to neonatal intensive care unit (NICU)
Time frame: During initial hospitalization, up to one week of age
Length of NICU admission
Time frame: During initial hospitalization, up to the age of three months
Number of pregnancies with neonatal respiratory complications related to maternal diabetes
Time frame: During initial hospitalization, up to one week of age
Number of pregnancies with neonatal hyperbilirubinemia
Time frame: During initial hospitalization, up to two weeks of age
Maternal HbA1c concentration
Time frame: Close to 12, 21 and 32 weeks of gestation
Glucose management indicator (GMI)
Time frame: Close to 12, 21 and 32 weeks of gestation
Time in glycemic range (TIR)
Time frame: Close to 12, 21 and 32 weeks of gestation
Time above glucose range
Time frame: Close to 12, 21 and 32 weeks of gestation
Time below glucose range
Time frame: Close to 12, 21 and 32 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. To ensure study subject anonymity the study data will not be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mikael Huhtala, M.D., Ph.D. principal investigator
Turku University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy in Diabetic and Diabetes Mellitus, Type 1, run by Turku University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Huhtala, M.D., Ph.D. (+35823130000, misahu@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal liver ultrasound texture (time frame: 34+0 - 34+6 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.