Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma

Completed

• Conditions: Exposure to Magnetic Field; Uterine Leiomyoma
• Interventions: Procedure: Magnetic Resonance Image

• Registration Number: NCT01468402
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.

Detailed Description

This study followed symptomatic premenopausal women with uterine leiomyoma who underwent uterine artery embolization (UAE). Treatment was accompanied by magnetic resonance imaging of both the volume of the entire uterus and the leiomyomas one month before and six months after UAE. This patients were treated at the Uterine Leiomyoma Sector of the Department of Obstetrics and Gynecology, Medicine College of the University of São Paulo. In this study, the investigators examined 179 leiomyomas in 50 patients.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-04
• Study Completion: 2009-08
• Study First Submitted: 2011-10-23
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• ultrasound diagnosis of uterine leiomyoma
• presence of symptoms (menorrhalgia and/or pelvic pain)
• indication for UAE(the desire to keep the uterus and/or contraindications for surgery).

Exclusion Criteria

• malignant genital neoplasms
• pelvic inflammatory disease
• allergy to iodinated contrast
• coagulopathy, renal failure
• vasculitis
• pelvic irradiation
• pregnancy
• subserosal leiomyoma with a pedicle smaller than 50% of diameter of the fibroid.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Magnetic Resonanse Image	Magnetic Resonance Image	The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroid, and their location in the myometrium was classified. Perfusion and the characterization of the T2 signal were also evaluated.

Primary Outcome Measures

Name	Time	Method
Leiomyoma reduction in patients who underwent uterine artery embolization	One month before(baseline) and six month after the embolization	Use the magnetic resonanse to evaluate factors that predicted leiomyoma reduction in patients who underwent uterine artery embolization

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, SP, Brazil