Clinical trial NCT06343974: Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Official title: Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy in Diabetic
Diabetes Mellitus, Type 1
Keywords: ultrasonography
fetus
radiomics
hyperinsulinemia
liver
pregnancy
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women will be recruited at Turku University Hospital and Turku maternity welfare clinics during their routine pregnancy follow-up.

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.

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.

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

Primary outcomes:
measure: Fetal liver ultrasound texture
timeFrame: 34+0 - 34+6 weeks of gestation
Secondary outcomes:
measure: Birth weight in grams
timeFrame: After delivery, up to 24 hours
measure: Birth weight centile
timeFrame: After delivery, up to 24 hours
measure: Large for gestational age (LGA)
timeFrame: After delivery, up to 24 hours
measure: Interventricular septum (IVS) width
timeFrame: 34+0 - 34+6 weeks of gestation
measure: Number of pregnancies with neonatal hypoglycemia
timeFrame: During initial hospitalization, up to one week of age
measure: Rate of neonatal hypoglycemia treated with oral dextrose gel
timeFrame: During initial hospitalization, up to three weeks of age
measure: Rate of neonatal hypoglycemia treated with intravenous (IV) glucose
timeFrame: During initial hospitalization, up to three weeks of age
measure: Length of treatment for neonatal hypoglycemia
timeFrame: During initial hospitalization, up to three weeks of age
measure: Number of neonates admitted to neonatal intensive care unit (NICU)
timeFrame: During initial hospitalization, up to one week of age
measure: Length of NICU admission
timeFrame: During initial hospitalization, up to the age of three months
measure: Number of pregnancies with neonatal respiratory complications related to maternal diabetes
timeFrame: During initial hospitalization, up to one week of age
measure: Number of pregnancies with neonatal hyperbilirubinemia
timeFrame: During initial hospitalization, up to two weeks of age
measure: Maternal HbA1c concentration
timeFrame: Close to 12, 21 and 32 weeks of gestation
measure: Glucose management indicator (GMI)
timeFrame: Close to 12, 21 and 32 weeks of gestation
measure: Time in glycemic range (TIR)
timeFrame: Close to 12, 21 and 32 weeks of gestation
measure: Time above glucose range
timeFrame: Close to 12, 21 and 32 weeks of gestation
measure: Time below glucose range
timeFrame: Close to 12, 21 and 32 weeks of gestation
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Mikael Huhtala, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: