NCT06265974

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 1, 2024

Last Update Submit

February 11, 2024

Conditions

Keywords

Quality

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women having undergone an ultrasound between 18 weeks and 18 weeks + 6 days at the Multidisciplinary Prenatal Diagnostic Center of Poitiers University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital La MILETRIE

Poitiers, 86000, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 20, 2024

Study Start

August 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 31, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations