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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06265974
Other study ID # ECHOQUALITY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date January 31, 2024

Study information

Verified date February 2024
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool. The main question it aims to answer is: Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements. The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date January 31, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient who underwent ultrasound between 18 weeks and 18 weeks + 6 days for prenatal diagnosis - Ultrasound performed by the same practitioner - Ultrasound performed on the same ultrasound machine "Voluson E10", with the "RM6C" probe Exclusion Criteria: - Patient's refusal - Use of another ultrasound device other than the "Voluson E10", and/or an ultrasound probe other than the "RM6C" - Intrauterine fetal deaths

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France University Hospital La MILETRIE Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image Both an experienced operator (a Ph.D. doctor) and a novice operator (a residency student) subjectively evaluated the contrast and noise of each region of interest previously chosen. Contrast was scored on a scale of 1 to 3, with 1 indicating low contrast, 2 for medium, and 3 for high contrast. Noise was scored on the same scale, with 1 corresponding to low noise, 2 for medium, and 3 for high noise. The subjective contrast to noise ratio (CNR) was determined by the ratio between these two scores.
To assess the objective CNR, computer-assisted image analysis was performed using MATLAB software.
baseline
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