Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

Ultrasonography, Prenatal Clinical Trial

— Auto-2T  

Official title:

Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441866
• Other study ID #: NP3574
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy 19+0-21+6 weeks

• Live fetus

• No fetal abnormalities

Exclusion Criteria:

• Multiple pregnancy

• Intrauterine fetal death

• Fetal abnormalities

Related Conditions & MeSH terms

• Ultrasonography, Prenatal

Intervention

Diagnostic Test:
• Automated algorithms
Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
• Standard technique
Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy

Locations

Country	Name	City	State
Italy	Spedali Ciivli	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of ultrasound examination	Duration of ultrasound examination in minutes	During ultrasound examination
Secondary	Quality score of fetal biometry	Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)	During ultrasound examination
Secondary	Quality score of fetal diagnostic planes	Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best)	During ultrasound examination
Secondary	Operator satisfaction	Visual analogue scale: from 0 (worst) to 32 (best)	During ultrasound examination