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This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan.
In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy. Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made, or of possibility of acquiring diagnostic planes, there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan.
The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, in terms of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated algorithms | Active Comparator | Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes |
|
| Standard technique | Placebo Comparator | Standard 2D assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated algorithms | Diagnostic Test | Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ultrasound examination | Duration of ultrasound examination in minutes | During ultrasound examination |
| Measure | Description | Time Frame |
|---|---|---|
| Quality score of fetal biometry | Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best) | During ultrasound examination |
| Quality score of fetal diagnostic planes | Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Ciivli | Brescia | Italy |
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| Standard technique | Diagnostic Test | Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy |
|
| During ultrasound examination |
| Operator satisfaction | Visual analogue scale: from 0 (worst) to 32 (best) | During ultrasound examination |