Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343974
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Brief Title:
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None