Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

Not Applicable

Completed

• Conditions: Ultrasonography, Prenatal
• Interventions: Diagnostic Test: Automated algorithms; Diagnostic Test: Standard technique

• Registration Number: NCT04441866
• Lead Sponsor: Università degli Studi di Brescia

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

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-18
• Study Start: 2020-06-19
• Study First Posted: 2020-06-22
• Primary Completion: 2020-09-30
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• Singleton pregnancy 19+0-21+6 weeks
• Live fetus
• No fetal abnormalities

Exclusion Criteria

• Multiple pregnancy
• Intrauterine fetal death
• Fetal abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated algorithms	Automated algorithms	Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes
Standard technique	Standard technique	Standard 2D assessment

Primary Outcome Measures

Name	Time	Method
Duration of ultrasound examination	During ultrasound examination	Duration of ultrasound examination in minutes

Secondary Outcome Measures

Name	Time	Method
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)
Quality score of fetal biometry	During ultrasound examination	Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)

Trial Locations

Locations (1)

Spedali Ciivli; 🇮🇹 Brescia, Italy