Clinicians' Trust in AI-Based Fetal Growth Estimates

NCT07401368 — Not applicable, Enrolling by invitation, 130 participants, Copenhagen University Hospital, Rigshospitalet

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

Registry	NCT07401368
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, health services research
Enrollment	130 (Estimated)
Sponsor	Copenhagen University Hospital, Rigshospitalet (Other); collaborators: Slagelse Hospital, Copenhagen Academy for Medical Education and Simulation
Conditions	Fetal Growth, Obstetric Ultrasonography, Pregnancy, Clinical Decision-making
Interventions	Intervention - AI Performance Information (Other)
Dates	start 2026-04-27, primary completion 2027-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-02-10, last updated 2026-08-05
Locations	1 site in Denmark

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Control - No AI Performance Information	No intervention		Participants complete the questionnaire without receiving information about the AI model's overall performance.
ntervention - AI Performance Information	Other	Other: Intervention - AI Performance Information	Participants receive brief information about the AI model's overall performance before completing the questionnaire.

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

+Outcome measures

Primary outcomes

Clinicians' choice of fetal weight estimation method [Immediately after questionnaire completion]: The 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 outcomes

Clinicians' confidence in selected fetal weight estimate [Immediately after questionnaire completion]: Clinicians' self-reported confidence in the selected fetal weight estimate, measured on a 7-point Likert scale for each case.
Recommendation of follow-up growth scan [Immediately after questionnaire completion]: Whether 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 preference [Immediately after questionnaire completion]: Difference in clinicians' preference for AI-based versus traditional fetal weight estimates when AI predictions are presented with versus without uncertainty information.

+Eligibility

Sex: All, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Department of Obstetrics and Gynecology, Slagelse Hospital	Slagelse	Denmark