Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment2000 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedMarch 11, 2026
Main results expectedJanuary 2027
Study endsFebruary 2027
Registry record updatedMay 20, 2026
Trial IDNCT07598097 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.