UltrasonographyNCT06265974
Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio
An observational study of Ultrasonography and Obstetrics, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ultrasonography, Obstetrics
- How many people
- 198 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECHOQUALITY: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio
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:
Read more
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
- Conditions
- Ultrasonography, Obstetrics
- Keywords
- Quality
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Aug 2023
- Primary completion1 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265974
- Sponsor's protocol ID
- ECHOQUALITY
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECHOQUALITY: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio
- ClinicalTrials.gov ID
- NCT06265974
- Acronym / sponsor ID
- ECHOQUALITY
- Conditions
- Ultrasonography, Obstetrics
- Keywords
- Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image
Time frame: baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Obstetrics, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.