Diabetes Mellitus, Type 1, Pregnancy in Diabetic
Conditions
Keywords
ultrasonography, fetus, radiomics, hyperinsulinemia, liver, pregnancy
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.
Interventions
None listed
Sponsors
Turku University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal liver ultrasound texture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight centile | After delivery, up to 24 hours | Birth weight adjusted for gestational age, fetal sex, and maternal parity. |
| Large for gestational age (LGA) | After delivery, up to 24 hours | Birth weight above 90th centile |
| Interventricular septum (IVS) width | 34+0 - 34+6 weeks of gestation | Fetal cardiac interventricular septum (IVS) width, measured at 34 gestational weeks |
| Number of pregnancies with neonatal hypoglycemia | During initial hospitalization, up to one week of age | Neonatal plasma glucose \< 2.6 mmol/L |
| Rate of neonatal hypoglycemia treated with oral dextrose gel | During initial hospitalization, up to three weeks of age | Neonatal plasma glucose \< 2.6 mmol/L and treatment with oral dextrose gel |
| Rate of neonatal hypoglycemia treated with intravenous (IV) glucose | During initial hospitalization, up to three weeks of age | Neonatal plasma glucose \< 2.6 mmol/L and treatment with IV glucose |
| Length of treatment for neonatal hypoglycemia | During initial hospitalization, up to three weeks of age | Length of dextrose gel or IV glucose treatment (days) |
| Number of neonates admitted to neonatal intensive care unit (NICU) | During initial hospitalization, up to one week of age | Neonatal admission to NICU |
| Birth weight in grams | After delivery, up to 24 hours | Birth weight in grams as routinely measured after birth. |
| Number of pregnancies with neonatal respiratory complications related to maternal diabetes | During initial hospitalization, up to one week of age | Diagnosis of respiratory distress syndrome and/or transient tachypnea of the newborn |
| Number of pregnancies with neonatal hyperbilirubinemia | During initial hospitalization, up to two weeks of age | Neonatal hyperbilirubinemia requiring phototherapy |
| Maternal HbA1c concentration | Close to 12, 21 and 32 weeks of gestation | Maternal HbA1c (mmol/mol) |
| Glucose management indicator (GMI) | Close to 12, 21 and 32 weeks of gestation | HbA1c estimation based on continuous glucose monitoring (CGM) or flash glucose monitoring data |
| Time in glycemic range (TIR) | Close to 12, 21 and 32 weeks of gestation | Time in glycemic range (TIR), if using CGM or flash monitoring |
| Time above glucose range | Close to 12, 21 and 32 weeks of gestation | Time above glucose range, if using CGM or flash monitoring |
| Time below glucose range | Close to 12, 21 and 32 weeks of gestation | Time below glucose range, if using CGM or flash monitoring |
| Length of NICU admission | During initial hospitalization, up to the age of three months | Length of NICU admission (days) |
Countries
Finland
Contacts
Primary ContactMikael Huhtala, M.D., Ph.D.
Outcome results
None listed