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临床试验/NCT01468402
NCT01468402已完成不适用

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

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Leiomyoma reduction in patients who underwent uterine artery embolization

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Leiomyoma reduction in patients who underwent uterine artery embolization

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eduardo Zlotnik

Principal Investigator

Hospital Israelita Albert Einstein

研究点 (1)

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