NCT04135118

Validation of the Adenomyosis Calculator

Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: Female
• Age: 52 Years
• Healthy volunteers: Not accepted

Summary

Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed. In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.

Conditions

• Adenomyosis
• Pelvic Pain Syndrome

Timeline

• Start date: 2020-01-02
• Primary completion: 2022-06-23
• Completion: 2022-09-01
• First posted: 2019-10-22
• Last updated: 2023-12-27

Locations

5 sites across 2 countries: Finland, Norway