Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound (Auto-2T)

Università degli Studi di Brescia

Status: Completed

Conditions: Ultrasonography, Prenatal

Treatments: Diagnostic Test: Automated algorithms; Diagnostic Test: Standard technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04441866

NP3574

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Multiple pregnancy
• Intrauterine fetal death
• Fetal abnormalities

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

Automated algorithms

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Automated algorithms

Standard technique

Placebo Comparator group

Description:

Standard 2D assessment

Treatment:

Diagnostic Test: Standard technique