The Study Aims to Improve the Accuracy of Detecting Spina Bifida During Early Ultrasound Scans. to Achieve This, an AI Model Has Been Developed to Provide Feedback About the Presence of Spina Bifida. a RCT Has Been Designed to Compare the Effectiveness of AI Feedback with No AI Feedback.

Completed

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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Dysraphism

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

About this study

The study aims to improve the accuracy of detecting spina bifida during early ultrasound scans. To achieve this, an AI model has been developed to provide feedback about the presence of spina bifida. A randomized controlled trial (RCT) has been designed to compare the effectiveness of AI feedback with no AI feedback. Forty fetal medicine specialists are randomly assigned to receive either the AI feedback or no feedback, and the two groups are compared to determine if the feedback improved the accuracy of detecting spina bifida.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Obstetricians

Exclusion criteria

Fetal medicine specialists

Treatment and study plan

Evaluation of XAI-assisted spina bifida diagnosis

Other

AI feedback

Primary outcomes

Evaluation of XAI-assisted spina bifida diagnosis

Time frame: One month after the survey is distributed.

The study aims to evaluate whether AI feedback improve the accuracy of diagnosing spina bifida by comparing the number of correct and incorrect responses in a task involving 20 images.

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Registry information

Official study title

Evaluation of XAI-assisted Spina Bifida Diagnosis

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 22, 2024
Registry last updated: Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed