Ultrasonography, Prenatal
Conditions
Brief summary
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
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
Interventions
DIAGNOSTIC_TESTAutomated algorithms
Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
DIAGNOSTIC_TESTStandard technique
Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Singleton pregnancy 19+0-21+6 weeks * Live fetus * No fetal abnormalities
Exclusion criteria
* Multiple pregnancy * Intrauterine fetal death * Fetal abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ultrasound examination | During ultrasound examination | Duration of ultrasound examination in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality score of fetal biometry | During ultrasound examination | Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best) |
| Quality score of fetal diagnostic planes | During ultrasound examination | Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best) |
| Operator satisfaction | During ultrasound examination | Visual analogue scale: from 0 (worst) to 32 (best) |
Countries
Italy
Outcome results
None listed