Randomised trial of gelatin versus embospheres for uterine fibroid embolisatio

Completed

• Conditions: terine fibroids; Cancer; Leiomyoma of uterus

• Registration Number: ISRCTN71074145
• Lead Sponsor: Greater Glasgow and Clyde NHS Board (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-23
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Patients referred for uterine artery embolisation

Added 13/02/2009:
2. Females aged 18 - 55 years

Exclusion Criteria

1. Pregnant
2. Allergy to radiographic contrast media
3. Unable to tolerate magnetic resonance imaging (MRI) scan

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of fibroid infarction using contrast enhanced MRI, assessed at baseline, 1, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Assessed at baseline, 1, 6 and 12 months:<br>1. Ovarian function and reserve <br>2. Quality of life, assessed by Euroqol, Uterine Fibroid Symptom and Quality of Life questionnaire (UFSQoL)<br>3. Symptom relief, assessed by a linear 11-point score -5 through zero to + 5<br>4. Reintervention rate