| Registry | NCT06268392 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 150 (Estimated) |
| Sponsor | Copenhagen Academy for Medical Education and Simulation (Other); collaborators: Slagelse Hospital, Technical University of Denmark, Copenhagen University Hospital, Rigshospitalet |
| Conditions | Fetal Growth Retardation, Fetal Macrosomia, Fetal Growth |
| Dates | start 2024-02-15 (estimated), primary completion 2024-08-01 (estimated), completion 2024-08-01 (estimated), first posted 2024-02-20, last updated 2024-02-22 |
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All trials for Fetal Growth Retardation All trials for Fetal Macrosomia
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.
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. .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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.