A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound

Not yet recruiting

• Conditions: Fetal Macrosomia; Fetal Growth; Fetal Growth Retardation

• Registration Number: NCT06268392
• Lead Sponsor: Copenhagen Academy for Medical Education and Simulation

Brief Summary

This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.

Detailed Description

The goal of this study is to compare the effects of two distinct AI methods on fetal ultrasound diagnostic accuracy. It serves as a supplementary investigation to the SCAN-AID study (NCT NCT06232187). This study aims will compare the diagnostic accuracy of two types of AI methods.

From the SCAN-AID study ultrasound novices were randomized into one of three groups with different levels of AI support: control group, AI feedback group 1 where the participants are presented with basic black box AI feedback, and AI feedback group 2 where the participants are presented with a more detailed explainable AI feedback. All the participants are tasked to perform an ultrasound fetal weight estimation (EFW) on pregnant women at gestational age 30-37. The outcomes were than compared to the expert sonographers measurements.

In this study an operator independent AI method that predicts the fetal weight is used on the SCAN-AID ultrasound examinations. .

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study Start: 2024-02-15
• Study First Posted: 2024-02-20
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Singelton pregnant.
• Gestational age: 30-38 weeks
• Maternal age < 40 years

Exclusion Criteria

• Oligo hydramnion
• Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc.
• Severe fetal macrosomia or growth restriction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal weight	10 minutes	Estimation of fetal weight, generated from AI analysis of fetal ultrasound images.
Ultrasound fetal weight estimation	15 minutes	Estimation of fetal weight, calculated from hadlock formula with information from the three standard planes of the head, abdomen and femur.