The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women aged ≥18 years
Attending routine second-trimester scan (and scheduled transvaginal cervical assessment per local protocol/workflow)
Disqualifiers
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
Trial population
Pregnant women attending routine second-trimester scan at Rigshospitalet from March to September, 2026.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cervical ultrasound image acquisition
Other interventionAcquisition of cervical ultrasound images with variation in image acquisition parameters.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Pregnant women attending routine second-trimester scan1 intervention
Trial outcomes
Primary outcomes
1
Spontaneous preterm birth <37+0 weeks
Birth \<37+0 weeks after spontaneous onset of labor (with or without preterm prelabor rupture of membranes \[PPROM\]), regardless of mode of delivery, and excluding medically indicated (iatrogenic) preterm births without spontaneous onset.
Time frame
At delivery.Secondary outcomes
1
Spontaneous preterm birth <34+0 and <32+0 weeks
Time frame
At delivery.Other outcomes
1
Any preterm birth (including medically indicated)
Time frame
At delivery.2
Time-to-delivery from scan
Time frame
From second-trimester scan until delivery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Department of Computer Science, University of Copenhagen, Denmark
Collaborator
Technical University of Denmark
Collaborator
Sundhedsdonationer
Collaborator
Source ClinicalTrials.gov