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Completed

NCT Number: NCT04441866

Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound

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.

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Key information

Conditions

Ultrasonography, Prenatal

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Spedali Ciivli

Brescia, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Multiple pregnancy
  • Intrauterine fetal death
  • Fetal abnormalities

Treatment and study plan

Automated algorithms

Diagnostic Test

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

Standard technique

Diagnostic Test

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

Primary outcomes

  1. Duration of ultrasound examination

    Time frame: During ultrasound examination

    Duration of ultrasound examination in minutes

Secondary outcomes

  1. Quality score of fetal biometry

    Time frame: During ultrasound examination

    Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)

  2. 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)

  3. Operator satisfaction

    Time frame: During ultrasound examination

    Visual analogue scale: from 0 (worst) to 32 (best)

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Acronym: Auto-2T

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 22, 2020
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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