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Clinicians' Trust in AI-Based Fetal Growth Estimates

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07401368
Enrollment
130
Registered
2026-02-10
Start date
2026-04-27
Completion date
2028-12-01
Last updated
2026-08-05

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

Conditions

Clinical Decision-making, Fetal Growth, Obstetric Ultrasonography, Pregnancy

Keywords

Clinical decision-making, Artificial intelligence, Fetal weight estimation, Obstetric ultrasound, Trust, Human-AI interaction, Questionnaire study

Brief summary

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

OTHERIntervention - AI Performance Information

Participants receive brief information about the AI model's overall performance before completing the questionnaire.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER
Slagelse Hospital
CollaboratorOTHER
Copenhagen Academy for Medical Education and Simulation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

Participants are unaware of their allocation to the control or intervention group and are not informed that different versions of the questionnaire exist.

Intervention model description

Participants are randomized to either an intervention group receiving information about AI model performance or a control group without such information. Groups are assessed in parallel.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinicians' choice of fetal weight estimation methodImmediately after questionnaire completionThe proportion of cases in which clinicians choose the AI-based fetal weight estimate rather than the traditional Hadlock estimate when assessing anonymized ultrasound cases.

Secondary

MeasureTime frameDescription
Clinicians' confidence in selected fetal weight estimateImmediately after questionnaire completionClinicians' self-reported confidence in the selected fetal weight estimate, measured on a 7-point Likert scale for each case.
Recommendation of follow-up growth scanImmediately after questionnaire completionWhether clinicians recommend a follow-up fetal growth scan based on the selected fetal weight estimate, recorded as a binary outcome (yes/no).
Impact of uncertainty information on model preferenceImmediately after questionnaire completionDifference in clinicians' preference for AI-based versus traditional fetal weight estimates when AI predictions are presented with versus without uncertainty information.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026