Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06343974
Other study ID # 0843
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date May 1, 2026

Study information

Verified date April 2024
Source Turku University Hospital
Contact Mikael Huhtala, M.D., Ph.D.
Phone +35823130000
Email misahu@utu.fi
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 pregnancies complicated by type 1 diabetes and healthy controls? Participants will undergo ultrasound examination to collect ultrasound data for the analyses.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date May 1, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Locations

Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)

Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 34+0 - 34+6 weeks of gestation
Secondary Birth weight in grams Birth weight in grams as routinely measured after birth. After delivery, up to 24 hours
Secondary Birth weight centile Birth weight adjusted for gestational age, fetal sex, and maternal parity. After delivery, up to 24 hours
Secondary Large for gestational age (LGA) Birth weight above 90th centile After delivery, up to 24 hours
Secondary Interventricular septum (IVS) width Fetal cardiac interventricular septum (IVS) width, measured at 34 gestational weeks 34+0 - 34+6 weeks of gestation
Secondary Number of pregnancies with neonatal hypoglycemia Neonatal plasma glucose < 2.6 mmol/L During initial hospitalization, up to one week of age
Secondary Rate of neonatal hypoglycemia treated with oral dextrose gel Neonatal plasma glucose < 2.6 mmol/L and treatment with oral dextrose gel During initial hospitalization, up to three weeks of age
Secondary Rate of neonatal hypoglycemia treated with intravenous (IV) glucose Neonatal plasma glucose < 2.6 mmol/L and treatment with IV glucose During initial hospitalization, up to three weeks of age
Secondary Length of treatment for neonatal hypoglycemia Length of dextrose gel or IV glucose treatment (days) During initial hospitalization, up to three weeks of age
Secondary Number of neonates admitted to neonatal intensive care unit (NICU) Neonatal admission to NICU During initial hospitalization, up to one week of age
Secondary Length of NICU admission Length of NICU admission (days) During initial hospitalization, up to the age of three months
Secondary Number of pregnancies with neonatal respiratory complications related to maternal diabetes Diagnosis of respiratory distress syndrome and/or transient tachypnea of the newborn During initial hospitalization, up to one week of age
Secondary Number of pregnancies with neonatal hyperbilirubinemia Neonatal hyperbilirubinemia requiring phototherapy During initial hospitalization, up to two weeks of age
Secondary Maternal HbA1c concentration Maternal HbA1c (mmol/mol) Close to 12, 21 and 32 weeks of gestation
Secondary Glucose management indicator (GMI) HbA1c estimation based on continuous glucose monitoring (CGM) or flash glucose monitoring data Close to 12, 21 and 32 weeks of gestation
Secondary Time in glycemic range (TIR) Time in glycemic range (TIR), if using CGM or flash monitoring Close to 12, 21 and 32 weeks of gestation
Secondary Time above glucose range Time above glucose range, if using CGM or flash monitoring Close to 12, 21 and 32 weeks of gestation
Secondary Time below glucose range Time below glucose range, if using CGM or flash monitoring Close to 12, 21 and 32 weeks of gestation
See also
  Status Clinical Trial Phase
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT06050642 - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. N/A
Completed NCT05107544 - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes N/A
Active, not recruiting NCT04443153 - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes N/A
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT04569994 - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes Phase 1
Completed NCT04089462 - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study N/A
Completed NCT03143816 - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Phase 4
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Completed NCT04042207 - Diabeloop for Highly Unstable Type 1 Diabetes N/A
Not yet recruiting NCT06068205 - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting NCT05909800 - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes. Phase 2
Active, not recruiting NCT04974528 - Afrezza® INHALE-1 Study in Pediatrics Phase 3
Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
Recruiting NCT03988764 - Monogenic Diabetes Misdiagnosed as Type 1
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A