Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

NCT ID: NCT04441866

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-19
• Study Completion Date: 2021-04-30

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

Conditions

Ultrasonography, Prenatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Automated algorithms

Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes

Group Type: ACTIVE_COMPARATOR

Automated algorithms

Intervention Type: DIAGNOSTIC_TEST

Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy

Standard technique

Standard 2D assessment

Group Type: PLACEBO_COMPARATOR

Standard technique

Intervention Type: DIAGNOSTIC_TEST

Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy

Interventions

Automated algorithms

Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy

Intervention Type: DIAGNOSTIC_TEST

Standard technique

Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Multiple pregnancy
• Intrauterine fetal death
• Fetal abnormalities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Federico Prefumo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spedali Ciivli

Brescia, , Italy

Countries

Italy

Other Identifiers

NP3574

Identifier Type: -

Identifier Source: org_study_id