Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07598097

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Preterm Birth Artificial Intelligence (AI) in Diagnosis Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rigshospitalet, Copenhagen Univeristy Hospital

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Emilie Pi F Sejer, MD

CONTACT

[email protected]

0045 28890690

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical ultrasound image acquisition

Other

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

Primary outcomes

  1. Spontaneous preterm birth <37+0 weeks

    Time frame: 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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie Pi F Sejer, MD

CONTACT

[email protected]

0045 28890690

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Department of Computer Science, University of Copenhagen, Denmark
  • Sundhedsdonationer
  • Technical University of Denmark

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.