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Recruiting NCT07598097

The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice

— Observational Preterm Birth Artificial Intelligence (AI) in Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cervical ultrasound image acquisition.
Who it may be relevant to
Registry conditions: Preterm Birth, Artificial Intelligence (AI) in Diagnosis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice: A Prospective Observational Study

Overview

This study prospectively evaluates whether the performance of an already-developed artificial intelligence (AI) model for predicting spontaneous preterm birth changes when cervical ultrasound images are obtained using different ultrasound image settings. The primary research question is whether the AI model performs differently across images acquired with different imaging settings.

Interventions

  • Other Cervical ultrasound image acquisition
    Acquisition of cervical ultrasound images with variation in image acquisition parameters.

Primary outcome measures

  • Spontaneous preterm birth <37+0 weeks [Time frame: At delivery.]
Secondary outcome measures (1)
  • Spontaneous preterm birth <34+0 and <32+0 weeks [Time frame: At delivery.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Rigshospitalet, Copenhagen Univeristy Hospital — Copenhagen

Identifiers

NCT: NCT07598097 · P-2026-21388

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗