| Registry | NCT07402668 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 125 (Estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet (Other); collaborators: Technical University of Denmark, The Foundation of 17.12.1981, Department of Computer Science, University of Copenhagen, Denmark, Copenhagen Academy for Medical Education and Simulation |
| Conditions | Preterm Birth, Artificial Intelligence (AI) in Diagnosis |
| Interventions | AI prediction (binary), AI risk estimate (%) (Behavioral) |
| Dates | start 2026-02-03, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2026-02-11, last updated 2026-07-01 |
| Locations | 18 sites in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Birth All trials for Artificial Intelligence (AI) in Diagnosis All trials of AI prediction (binary) All trials of AI risk estimate (%)
The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and gynecology when assessing the risk of spontaneous preterm birth using clinical case vignettes with cervical ultrasound images. The study specifically compares two AI presentation formats: a binary classification (preterm vs term birth) and an individualized risk estimate of preterm birth.
The main questions it aims to answer are:
* Which AI presentation format leads to better alignment between clinicians' confidence and decision accuracy (diagnostic calibration)?
* Do different AI presentation formats lead to helpful or harmful changes in clinical decisions?
Participants will complete an online questionnaire in which they review clinical cases, make diagnostic and management decisions, rate their diagnostic confidence before and after seeing the AI output, and report their trust in the AI.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| AI prediction | Experimental | Behavioral: AI prediction (binary) | The participants receive a binary AI prediction (preterm or term birth) |
| AI risk estimate | Experimental | Behavioral: AI risk estimate (%) | The participants receive an AI risk estimate of preterm birth (%) |
Sex: All, accepts healthy volunteers
Inclusion Criteria: * Medical doctors currently working in or training within the field of obstetrics and gynecology. * Experience performing transvaginal cervical ultrasound examinations. Exclusion Criteria: \- No prior experience performing transvaginal cervical ultrasound examinations.
| Facility | City | Country | Status |
|---|---|---|---|
| South Jutland Hospital | Aabenraa | Denmark | Recruiting |
| Aalborg University Hospital (Aalborg and Thisted) | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital | Aarhus | Denmark | Recruiting |
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark | Recruiting |
| Esbjerg Hospital | Esbjerg | Denmark | Recruiting |
| Gødstrup Regional Hospital | Gødstrup | Denmark | Recruiting |
| Herlev Hospital | Herlev | Denmark | Recruiting |
| Copenhagen University Hospital, North Zealand | Hillerød | Denmark | Recruiting |
| Region Hospital North Jutland | Hjørring | Denmark | Recruiting |
| Holbæk Hospital | Holbæk | Denmark | Recruiting |
| Horsens Regional Hospital | Horsens | Denmark | Recruiting |
| Hvidovre Hospital | Hvidovre | Denmark | Recruiting |
| Kolding Hospital | Kolding | Denmark | Recruiting |
| Odense University Hospital (Odense and Svendborg) | Odense | Denmark | Recruiting |
| Randers Regional Hospital | Randers | Denmark | Recruiting |
| Zealand University Hospital (Roskilde and Nykøbing F.) | Roskilde | Denmark | Recruiting |
| Slagelse Hospital | Slagelse | Denmark | Recruiting |
| Viborg Regional Hospital | Viborg | Denmark | Recruiting |