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临床试验/NCT01916291
NCT01916291已完成2 期

Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2013年8月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
189
试验地点
2
主要终点
Induction success rate after propess insertion

研究概览

简要总结

Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who admitted for induction of labor
  • Bishop score <= 6

排除标准

  • Contraindication to induction of labor
  • Active labor
  • Vaginal bleeding, unknown origin
  • Hypersensitive to Prostaglandin E
  • History of asthma, glaucoma
  • Infection (birth canal)
  • Placental abruption
  • Multiparity(>5)
  • Pelvic inflammatory disease
  • Heart, lung, kidney disease
  • Multiple pregnancy
  • Major anomaly
  • Fetal distress before induction of labor

研究组 & 干预措施

Propess insertion

Experimental

干预措施: Propess insertion group (Drug)

结局指标

主要结局

Induction success rate after propess insertion

时间窗: Day 1 after propess insertion

次要结局

  • Concentration of prostaglandinE(at delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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