A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound

February 21, 2024 updated by: Mary Le Ngo, Copenhagen Academy for Medical Education and Simulation
This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The goal of this study is to compare the effects of two distinct AI methods on fetal ultrasound diagnostic accuracy. It serves as a supplementary investigation to the SCAN-AID study (NCT NCT06232187). This study aims will compare the diagnostic accuracy of two types of AI methods.

From the SCAN-AID study ultrasound novices were randomized into one of three groups with different levels of AI support: control group, AI feedback group 1 where the participants are presented with basic black box AI feedback, and AI feedback group 2 where the participants are presented with a more detailed explainable AI feedback. All the participants are tasked to perform an ultrasound fetal weight estimation (EFW) on pregnant women at gestational age 30-37. The outcomes were than compared to the expert sonographers measurements.

In this study an operator independent AI method that predicts the fetal weight is used on the SCAN-AID ultrasound examinations. .

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Medical students are recruited from the Medical universities in Denmark (mainly Copenhagen University) Pregnant women are chosen from the fetal medical departement at Rigshospitalet, Copenhagen.

Description

Pregnant women:

Inclusion Criteria:

  • Singelton pregnant.
  • Gestational age: 30-38 weeks
  • Maternal age < 40 years

Exclusion Criteria:

  • Oligo hydramnion
  • Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc.
  • Severe fetal macrosomia or growth restriction.

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

Cohorts and Interventions

Group / Cohort
Expert sonographer
Expert sonographers ultrasound examination.
Control Group (CG)
Control group ultrasound examination with no AI support.
Feedback group 1 (FG1)
Feedback group 1 ultrasound examination with basic black box AI support.
Feedback group 2 (FG2)
Feedback group 2 ultrasound examination with detailed explainable AI support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal weight
Time Frame: 10 minutes
Estimation of fetal weight, generated from AI analysis of fetal ultrasound images.
10 minutes
Ultrasound fetal weight estimation
Time Frame: 15 minutes
Estimation of fetal weight, calculated from hadlock formula with information from the three standard planes of the head, abdomen and femur.
15 minutes

Collaborators and Investigators

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

Sponsor

Copenhagen Academy for Medical Education and Simulation

Collaborators

Rigshospitalet, Denmark
Slagelse Hospital
Technical University of Denmark

Investigators

  • Study Director: Martin Tolsgaard, CAMES rigshopsitalet

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 (Estimated)

February 15, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-2023-11-20-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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