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

June 9, 2021 updated by: Federico Prefumo, Università degli Studi di Brescia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy
        • Spedali Ciivli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple pregnancy
  • Intrauterine fetal death
  • Fetal abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of ultrasound examination
Time Frame: During ultrasound examination
Duration of ultrasound examination in minutes
During ultrasound examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality score of fetal biometry
Time Frame: During ultrasound examination
Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)
During ultrasound examination
Quality score of fetal diagnostic planes
Time Frame: During ultrasound examination
Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best)
During ultrasound examination
Operator satisfaction
Time Frame: During ultrasound examination
Visual analogue scale: from 0 (worst) to 32 (best)
During ultrasound examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NP3574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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