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临床试验/NCT00325026
NCT00325026已完成2 期

Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

University of Florida2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2005年4月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
130
试验地点
2
主要终点
Time to vaginal delivery

研究概览

简要总结

The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

详细描述

Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton gestation, gestational age 23-35 weeks, indication for induction

排除标准

  • multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

结局指标

主要结局

Time to vaginal delivery

次要结局

  • Rate of chorioamnionitis
  • Incidence of abnormal fetal heart rate tracings
  • Rate of postpartum hemorrhage
  • Incidence of NICU admissions

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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