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Recruiting NCT07402668

NCT07402668 Does AI Make Clinicians More Appropriately Confident? A Randomized Study in Preterm Birth Prediction

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Clinical Trial Summary
NCT ID NCT07402668
Status Recruiting
Phase
Sponsor Rigshospitalet, Denmark
Condition Preterm Birth
Study Type INTERVENTIONAL
Enrollment 125 participants
Start Date 2026-02-03
Primary Completion 2026-07

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type INTERVENTIONAL
Interventions
AI prediction (binary)AI risk estimate (%)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 125 participants in total. It began in 2026-02-03 with a primary completion date of 2026-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Emilie Pi F Sejer, MD

✉ emilie.pi.fogtmann.sejer.01@regionh.dk

📞 0045 28890690

Principal Investigator

Martin G Tolsgaard, MD, PhD, DMSc

STUDY CHAIR

Department of Obstetrics and Gynecology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark

Frequently Asked Questions

Who can join the NCT07402668 clinical trial?

This trial is open to participants of all sexes, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07402668 currently recruiting?

Yes, NCT07402668 is actively recruiting participants. Contact the research team at emilie.pi.fogtmann.sejer.01@regionh.dk for enrollment information.

Where is the NCT07402668 trial being conducted?

This trial is being conducted at Aabenraa, Denmark, Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark and 11 additional locations.

Who is sponsoring the NCT07402668 clinical trial?

NCT07402668 is sponsored by Rigshospitalet, Denmark. The principal investigator is Martin G Tolsgaard, MD, PhD, DMSc at Department of Obstetrics and Gynecology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. The trial plans to enroll 125 participants.

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