NCT06566014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

May 22, 2024

Last Update Submit

December 2, 2024

Conditions

Spina Bifida

Outcome Measures

Primary Outcomes (1)

  • Evaluation of XAI-assisted spina bifida diagnosis

    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.

    One month after the survey is distributed.

Study Arms (2)

AI feedback

EXPERIMENTAL

The participant will receive AI feedback upon completing the task of analyzing 20 images. The AI feedback will include a prediction (Normal/Spina Bifida) along with a confidence score ranging from 0.0 to 1.0, where 0.0 indicates the lowest confidence and 1.0 indicates the highest confidence.

Other: Evaluation of XAI-assisted spina bifida diagnosis

No AI feedback

PLACEBO COMPARATOR

The participants will complete the task of analyzing 20 images without any AI feedback.

Other: Evaluation of XAI-assisted spina bifida diagnosis

Interventions

Evaluation of XAI-assisted spina bifida diagnosisOTHER

AI feedback

AI feedbackNo AI feedback

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Obstetricians

You may not qualify if:

  • Fetal medicine specialists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2024

First Posted

August 22, 2024

Study Start

July 1, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

DK(1)