跳至主要内容
临床试验/NCT00690040
NCT00690040已完成不适用

Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2008年6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
293
试验地点
1
主要终点
Average Time in Hours From Insertion of the Catheter Until Delivery

研究概览

简要总结

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

研究设计

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

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Induction of labor is indicated
  • Gestational age between 24 - 42 weeks
  • Singleton pregnancy
  • Bishop score less than 7

排除标准

  • Any contraindication for vaginal delivery
  • Previous cesarean delivery
  • Low lying placenta
  • Rupture of membranes
  • Fetal malformations incompatible with life
  • intrauterine fetal death
  • Amnionitis
  • Genital viral infection (HIV, hepatitis C virus
  • , hepatitis B virus)
  • Allergy to latex

结局指标

主要结局

Average Time in Hours From Insertion of the Catheter Until Delivery

时间窗: At the end of the study

次要结局

  • To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups(At the end of the study)

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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