NCT04441866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 17, 2020

Last Update Submit

June 9, 2021

Conditions

Ultrasonography, Prenatal

Outcome Measures

Primary Outcomes (1)

  • Duration of ultrasound examination

    Duration of ultrasound examination in minutes

    During ultrasound examination

Secondary Outcomes (3)

  • Quality score of fetal biometry

    During ultrasound examination

  • Quality score of fetal diagnostic planes

    During ultrasound examination

  • Operator satisfaction

    During ultrasound examination

Study Arms (2)

Automated algorithms

ACTIVE COMPARATOR

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

Diagnostic Test: Automated algorithms

Standard technique

PLACEBO COMPARATOR

Standard 2D assessment

Diagnostic Test: Standard technique

Interventions

Automated algorithmsDIAGNOSTIC_TEST

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

Automated algorithms
Standard techniqueDIAGNOSTIC_TEST

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

Standard technique

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Multiple pregnancy
  • Intrauterine fetal death
  • Fetal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spedali Ciivli

Brescia, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 22, 2020

Study Start

June 19, 2020

Primary Completion

September 30, 2020

Study Completion

April 30, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)