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

Sponsor

Università degli Studi di Brescia (Other)

Overall Status

Completed

CT.gov ID

NCT04441866

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasonography, Prenatal	Diagnostic Test: Automated algorithms Diagnostic Test: Standard technique	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

Actual Study Start Date :

Jun 19, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Automated algorithms Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes	Diagnostic Test: Automated algorithms Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
Placebo Comparator: Standard technique Standard 2D assessment	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

Arm

Intervention/Treatment

Active Comparator: Automated algorithms

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

Diagnostic Test: Automated algorithms

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

Placebo Comparator: Standard technique

Standard 2D assessment

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

Outcome Measures

Primary Outcome Measures

Duration of ultrasound examination [During ultrasound examination]
Duration of ultrasound examination in minutes

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spedali Ciivli	Brescia		Italy

Sponsors and Collaborators

Università degli Studi di Brescia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Federico Prefumo, Associate Professor, Università degli Studi di Brescia

ClinicalTrials.gov Identifier:

NCT04441866

Other Study ID Numbers:

NP3574

First Posted:

Jun 22, 2020

Last Update Posted:

Jun 14, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 14, 2021