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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06268392

Enrollment

150

Registered

2024-02-20

Start date

2024-02-15

Completion date

2024-08-01

Last updated

2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth, Fetal Growth Retardation, Fetal Macrosomia

Keywords

Artificial Intelligence, Fetal weight estimation, Ultrasound

Brief summary

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

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. .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Contacts

Primary ContactMary L Ngo

mary.van.anh.le.ngo@regionh.dk+4520773779

Backup ContactMartin Tolsgaard

martin.groennebaek.tolsgaard@regionh.dk+4538664631

Outcome results