Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314178
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-06
Brief Title:
Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice Patients Eligible for Inclusion Are Women with a Gestational Age Between 24-42 Weeks Undergoing a Third-trimester Growth Scan the Image Data from the Scan Are Used to Calculate Fetal Weight
Sponsor:
Copenhagen Academy for Medical Education and Simulation
Organization:
Copenhagen Academy for Medical Education and Simulation
Study Overview
Official Title:
Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 a new artificial intelligence AI feedback tool with the traditional method for estimating fetal weight during ultrasound scans on pregnant women between 24-42 weeks of gestation The study aims to investigate the presence of demographic bias in the AI model The demographic factors examined in the study include Body Mass Index BMI the number of births fetal age mother39s age fetal sex and the presence of preeclampsia Moreover the study will compare the accuracy of the AI model and the Hadlock model a fetal growth formula in estimating fetal weight Participants will have their ultrasound scans pseudonymized and securely stored on password-protected removable drives ensuring their identity and privacy are maintained Afterward the ultrasound data will be sent to the Technical University of Denmark DTU where the AI model will analyze the images to estimate fetal weight
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None