- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401368
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zahra Bashir, MD
- Phone Number: 004574871407
- Email: zab@regsj.dk
Study Locations
-
-
-
Slagelse, Denmark, 4200
- Department of Obstetrics and Gynecology, Slagelse Hospital
-
Contact:
- Zahra Bashir, MD
- Phone Number: +45 58 55 37 05
- Email: zab@regsj.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control - No AI Performance Information
Participants complete the questionnaire without receiving information about the AI model's overall performance.
|
|
|
Other: ntervention - AI Performance Information
Participants receive brief information about the AI model's overall performance before completing the questionnaire.
|
Participants receive brief information about the AI model's overall performance before completing the questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinicians' choice of fetal weight estimation method
Time Frame: 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.
|
Immediately after questionnaire completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinicians' confidence in selected fetal weight estimate
Time Frame: Immediately after questionnaire completion
|
Clinicians' self-reported confidence in the selected fetal weight estimate, measured on a 7-point Likert scale for each case.
|
Immediately after questionnaire completion
|
|
Recommendation of follow-up growth scan
Time Frame: 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).
|
Immediately after questionnaire completion
|
|
Impact of uncertainty information on model preference
Time Frame: 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.
|
Immediately after questionnaire completion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F-25022462
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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