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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06268392
Other study ID # CT-2023-11-20-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 15, 2024
Est. completion date August 1, 2024

Study information

Verified date February 2024
Source Copenhagen Academy for Medical Education and Simulation
Contact Mary L Ngo
Phone +4520773779
Email mary.van.anh.le.ngo@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date August 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Pregnant women: 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Copenhagen Academy for Medical Education and Simulation Rigshospitalet, Denmark, Slagelse Hospital, Technical University of Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary Fetal weight Estimation of fetal weight, generated from AI analysis of fetal ultrasound images. 10 minutes
Primary Ultrasound fetal weight estimation Estimation of fetal weight, calculated from hadlock formula with information from the three standard planes of the head, abdomen and femur. 15 minutes
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