Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
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 |
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