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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07598097

Enrollment

2000

Registered

2026-05-20

Start date

2026-03-11

Completion date

2027-02-01

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence (AI) in Diagnosis, Preterm Birth

Keywords

Preterm birth, Premature birth, Artificial intelligence, Deep learning, Image acquisition, Diagnostic accuracy, Cervical ultrasound, Prospective validation

Brief summary

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

OTHERCervical ultrasound image acquisition

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Spontaneous preterm birth <37+0 weeks	At delivery.	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.

Secondary

Measure	Time frame
Spontaneous preterm birth <34+0 and <32+0 weeks	At delivery.

Countries

Denmark

Contacts

CONTACTEmilie Pi F Sejer, MD

emilie.pi.fogtmann.sejer.01@regionh.dk0045 28890690

STUDY_CHAIRMartin G Tolsgaard, MD, PhD, DMSc

Department of Obstetrics and Gynecology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026