NCT04576039

Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

If endometrial thickening is visualised (\>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology.

Detailed description

When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen. This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use.

Conditions

• Uterine Fibroid
• Endometrial Cyst

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	saline infusion sonography	Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-10-05
• Last updated: 2020-10-05

Locations

1 site across 1 country: Belgium