Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

Study Overview
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Brief Summary
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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.

Detailed Description
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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: duration of the ultrasound scan quality of biometric measurements quality of the diagnostic planes operator satisfaction

Official Title
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Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

Conditions
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Ultrasonography, Prenatal

Intervention / Treatment
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* Diagnostic Test: Automated algorithms
* Diagnostic Test: Standard technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy 19+0-21+6 weeks Live fetus No fetal abnormalities Exclusion Criteria: Multiple pregnancy Intrauterine fetal death Fetal abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Automated algorithms<br>Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes | Diagnostic Test: Automated algorithms<br>* Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy<br>|
| Placebo Comparator: Standard technique<br>Standard 2D assessment | Diagnostic Test: Standard technique<br>* Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ultrasound examination | Duration of ultrasound examination in minutes | During ultrasound examination | 

Secondary Outcome Measures

| Outcome Measure | 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) | During ultrasound examination | 
| Operator satisfaction | Visual analogue scale: from 0 (worst) to 32 (best) | During ultrasound examination |