NCT07476638

Brief Summary

Objective: To evaluate the impact of real-time AI feedback on fetal biometry accuracy and investigate the Expertise Reversal Effect-whether AI benefits diminish as user experience increases. Design: A stratified randomized trial of 75 participants (25 Novices, 25 Intermediates, 25 Experts). Users are randomized 1:1 to either AI-assisted or manual measurement groups. Outcomes:

  • Primary: EFW accuracy (MAPE) compared to actual birthweight.
  • Secondary: Procedure time, image quality, error relative to baseline scans, and cognitive workload (NASA-TLX).

Trial Health

63
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Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 26, 2026

Last Update Submit

March 26, 2026

Conditions

Fetal Growth AbnormalitiesFetal Weight

Keywords

Artificifial Intelligence feedbackFetal weight estimationExpertise reversal effectCognitive loadExplainable AIUltrasoundthird trimester

Outcome Measures

Primary Outcomes (1)

  • To evaluate the sensitivity to change in ultrasound measurement accuracy when using AI-feedback compared to standard scanning

    Mean absolute percentage error (MAPE), defined as the absolute difference between estimated fetal weight (EFW) and actual birth weight (ABW) divided by actual birth weight and expressed as a percentage, for AI-assisted and manual fetal biometry.

    The two scans will be performed within a timeframe of 14 days.

Secondary Outcomes (5)

  • Procedural Efficacy

    The duration of the scan, maximum of 30 minutes

  • Image Quality

    Through study completion, an average of 1 year.

  • Cognitive and Physiological Load

    During the ultrasound procedure (GSR) and immediately following the procedure (NASA-TLX), approximately 30 minutes in total.

  • Measurement Deviation:

    The duration from pre study scan and study scan.

  • Experience Threshold for AI-Mediated Accuracy Gains

    Through study completion, an average of 1 year.

Study Arms (2)

Control Group

NO INTERVENTION

Participants in the control arm perform fetal biometry using standard manual techniques without any AI assistance.

AI intervention Group

EXPERIMENTAL

The software provides real-time "traffic light" or score-based feedback to validate when the correct anatomical plane (BPD, HC, AC, or FL) has been reached.

Device: AI interventional group

Interventions

AI interventional groupDEVICE

Participants in the intervention arm perform fetal biometry with the assistance of real-time Artificial Intelligence (AI) feedback software.

AI intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • \- If the participants do not understand and speak either Danish or English
  • Pregnant women:
  • Pre pregnancy BMI \< 40
  • Singelton pregnancy
  • GA ≥ 37+0 at time of induction
  • Intact membranes (to ensure consistent amniotic fluid index)
  • Major fetal anatomical anomaly
  • Anhydramnios (DVP \< 2 cm)
  • CPR ratio \< 2.5th percentile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mary Le Ngo, Medical Doctor (MD), PhD stude

CONTACT

+45 20773779mary.van.anh.le.ngo.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Image quality assessors
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Stratified, parallel-group Randomized Controlled Trial (RCT) using a 3 x 2 factorial design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

DK(1)