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Enrolling by invitation NCT07401368

Clinicians' Trust in AI-Based Fetal Growth Estimates

No phase Interventional Fetal Growth Obstetric Ultrasonography Pregnancy Clinical Decision-making

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention - AI Performance Information.
Who it may be relevant to
Registry conditions: Fetal Growth, Obstetric Ultrasonography, Pregnancy, Clinical Decision-making. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinicians' Trust and Decision-Making Using AI-Based Fetal Growth Estimates With and Without Uncertainty: A Randomized Questionnaire Study

Overview

This study examines how clinicians trust and use artificial intelligence (AI) when estimating fetal weight during pregnancy. Accurate assessment of fetal growth is important for identifying growth problems that may affect pregnancy management. New AI-based tools can estimate fetal weight from ultrasound images, but little is known about how clinicians trust these estimates or how uncertainty information influences their decisions. In this study, clinicians will review anonymized ultrasound cases and compare fetal weight estimates generated by an AI model with traditional estimates. Some clinicians will also be shown information about the AI model's performance and uncertainty, while others will not. Participants will be asked to choose which estimate they find most reliable, indicate their level of confidence, and decide whether they would recommend follow-up scans. The study aims to better understand how AI and uncertainty information affect clinical decision-making and trust among clinicians with different levels of experience.

Detailed description

This is a randomized, matched, vignette-based questionnaire study designed to investigate clinicians' trust in and use of AI-based fetal growth estimates.

Clinicians from obstetrics and gynecology departments will be recruited and stratified by experience level. Participants will be randomized to either a control group or an intervention group. The intervention group will receive brief information about the AI model's overall performance, while the control group will not receive this information.

Each participant will assess a set of anonymized third-trimester ultrasound cases. For each case, clinicians will be presented with standard ultrasound images and relevant clinical context. They will be shown fetal weight estimates generated by an AI-based model and by a traditional biometric method, with or without accompanying uncertainty information in the form of confidence intervals.

For each case, clinicians will select the estimate they consider most clinically reliable, rate their confidence in that choice, and indicate whether they would recommend a follow-up growth scan. Case sets are matched by clinical experience, ensuring that identical cases are evaluated by clinicians with similar backgrounds across study arms.

The study focuses on clinicians as participants and involves no patient intervention. All ultrasound data are fully anonymized. The results will provide insight into how AI-generated estimates and uncertainty information influence clinical trust, preferences, and decision-making in fetal growth assessment.

Interventions

  • Other Intervention - AI Performance Information
    Participants receive brief information about the AI model's overall performance before completing the questionnaire.

Primary outcome measures

  • Clinicians' choice of fetal weight estimation method [Time frame: Immediately after questionnaire completion]
Secondary outcome measures (3)
  • Clinicians' confidence in selected fetal weight estimate [Time frame: Immediately after questionnaire completion]
  • Recommendation of follow-up growth scan [Time frame: Immediately after questionnaire completion]
  • Impact of uncertainty information on model preference [Time frame: Immediately after questionnaire completion]

Eligibility criteria

Inclusion criteria

  • Clinicians working in obstetrics and gynecology departments.
  • Regular use of obstetric ultrasound in clinical practice.
  • Willingness to participate in a questionnaire-based study.

Exclusion criteria

  • Clinicians who do not perform obstetric ultrasound examinations.
  • Clinicians with a known conflict of interest related to the AI system being evaluated.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Denmark · 1 center
  • Department of Obstetrics and Gynecology, Slagelse Hospital — Slagelse

Identifiers

NCT: NCT07401368 · F-25022462

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗