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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.

Evaluation of XAI-assisted Spina Bifida Diagnosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06566014
Enrollment
38
Registered
2024-08-22
Start date
2024-07-01
Completion date
2024-10-30
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spina Bifida

Brief summary

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.

Detailed description

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.

Interventions

OTHEREvaluation of XAI-assisted spina bifida diagnosis

AI feedback

Sponsors

Copenhagen Academy for Medical Education and Simulation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Obstetricians

Exclusion criteria

* Fetal medicine specialists

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of XAI-assisted spina bifida diagnosisOne 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026