跳至主要内容
临床试验/NCT01373255
NCT01373255已完成不适用

Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年1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
24
试验地点
1
主要终点
Number of blood products transfused

研究概览

简要总结

Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The most important risk factors are previous cesarean delivery, placenta previa, and advanced maternal age. Cesarean hysterectomy is the recommended management. During the recent years, inserting intravascular balloon catheter for occlusion and/or arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss during cesarean hysterectomy or in conduct with conservative management with the intent of avoiding hysterectomy in selective cases. Contradicting reports exist regarding the effectiveness and safety of the catheters in cases of placenta accreta. The objective of this study is to estimate the efficacy of the balloon catheters among women diagnosed with a placenta accreta.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • pregnant women age 18-45
  • antepartum diagnosis of placenta accreta

排除标准

  • women who refuse to participate

结局指标

主要结局

Number of blood products transfused

时间窗: 5 years

次要结局

  • Need for hysterectomy(5 years)
  • Length of hospitalization(5 years)
  • catheter's side effects(5 years)

研究者

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

Raed Salim

MD

HaEmek Medical Center, Israel

研究点 (1)

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