Impact of AI Feedback on Ultrasound Biometry Accuracy Across the Expertise Levels (NCT07476638) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of AI Feedback on Ultrasound Biometry Accuracy Across the Expertise Levels
Denmark75 participantsStarted 2026-03-01
Plain-language summary
Objective: To evaluate the impact of real-time AI feedback on fetal biometry accuracy and investigate the Expertise Reversal Effect-whether AI benefits diminish as user experience increases.
Design: A stratified randomized trial of 75 participants (25 Novices, 25 Intermediates, 25 Experts). Users are randomized 1:1 to either AI-assisted or manual measurement groups.
Outcomes:
* Primary: EFW accuracy (MAPE) compared to actual birthweight.
* Secondary: Procedure time, image quality, error relative to baseline scans, and cognitive workload (NASA-TLX).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinical Target Population: Healthcare professionals and students, including but not limited to:
* Medical students (doing their masters.
* Resident physicians and Senior Consultants in Obstetrics and Gynecology.
Exclusion:
\- If the participants do not understand and speak either Danish or English
Pregnant women:
Inclusion Criteria:
* Pre pregnancy BMI \< 40
* Singelton pregnancy
* GA ≥ 37+0 at time of induction
* Intact membranes (to ensure consistent amniotic fluid index)
Exclusion Criteria:
* Major fetal anatomical anomaly
* Anhydramnios (DVP \< 2 cm)
* CPR ratio \< 2.5th percentile
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the sensitivity to change in ultrasound measurement accuracy when using AI-feedback compared to standard scanning
Timeframe: The two scans will be performed within a timeframe of 14 days.
Trial details
NCT IDNCT07476638
SponsorCopenhagen Academy for Medical Education and Simulation