How cervical ultrasound settings affect AI prediction of preterm birth
Official title: The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice: A Prospective Observational Study
Run by Copenhagen University Hospital, Rigshospitalet · NCT07598097 · Data updated 2026-11-12
This study tests whether an AI model for predicting preterm birth performs differently when cervical ultrasound images are taken with different imaging settings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | January 2027 |
| Study ends | February 2027 |
| Registry record updated | May 20, 2026 |
| Trial ID | NCT07598097 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant adults 18 years or older receiving routine second-trimester ultrasound with planned transvaginal cervical assessment.
✕Probably not a fit
Patients whose images do not meet quality criteria or who do not have subsequent pregnancy outcome data may not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study examines an existing AI model that predicts spontaneous preterm birth to see if its performance varies with how cervical ultrasound images are acquired. Pregnant women in the second trimester undergoing routine scans with a transvaginal cervical assessment are enrolled. The study analyzes imaging settings and their impact on the AI model’s predictive accuracy using pregnancy outcomes. It focuses on real-world clinical practice to understand AI reliability across imaging variations.
Why it matters
Potential benefit: If successful, the findings could help standardize image acquisition to improve AI prediction of preterm birth.
How similar studies have gone: Previous work shows AI performance can vary with image quality and acquisition settings, but this study evaluates that issue in cervical ultrasound specifically.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women aged ≥18 years * Attending routine second-trimester scan (and scheduled transvaginal cervical assessment per local protocol/workflow) Exclusion Criteria: * Absence of transvaginal cervical assessment at the second-trimester scan * Missing follow-up data on pregnancy outcome (gestational age at delivery) * Inadequate image quality or missing required cervical ultrasound image
Where it's running
-
Rigshospitalet, Copenhagen Univeristy Hospital
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Emilie Pi F Sejer, MD
- Email: emilie.pi.fogtmann.sejer.01@regionh.dk
- Phone: 0045 28890690
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.