An observational study in Preterm Birth and Artificial Intelligence (AI) in Diagnosis, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Rigshospitalet, Denmark · Observational
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women attending routine second-trimester scan at Rigshospitalet from March to September, 2026.
Exclusion Criteria:
Pregnant women aged ≥18 years attending routine second-trimester scan (and scheduled transvaginal cervical assessment per local protocol/workflow).
Other: Cervical ultrasound image acquisition
Acquisition of cervical ultrasound images with variation in image acquisition parameters.
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.
Spontaneous preterm birth <34+0 and <32+0 weeks
Time frame: At delivery.
Any preterm birth (including medically indicated)
Time frame: At delivery.
Time-to-delivery from scan
Time frame: From second-trimester scan until delivery.
Plan to share: Undecided
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Rigshospitalet, Denmark