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

NCT ID: NCT06268392

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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. .

Conditions

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Fetal Growth Retardation Fetal Macrosomia Fetal Growth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Expert sonographer

Expert sonographers ultrasound examination.

No interventions assigned to this group

Control Group (CG)

Control group ultrasound examination with no AI support.

No interventions assigned to this group

Feedback group 1 (FG1)

Feedback group 1 ultrasound examination with basic black box AI support.

No interventions assigned to this group

Feedback group 2 (FG2)

Feedback group 2 ultrasound examination with detailed explainable AI support.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Slagelse Hospital

OTHER

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Copenhagen Academy for Medical Education and Simulation

OTHER

Sponsor Role lead

Responsible Party

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Mary Le Ngo

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Tolsgaard

Role: STUDY_DIRECTOR

CAMES rigshopsitalet

Central Contacts

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Mary L Ngo

Role: CONTACT

+4520773779

Martin Tolsgaard

Role: CONTACT

+4538664631

Other Identifiers

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CT-2023-11-20-001

Identifier Type: -

Identifier Source: org_study_id

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