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临床试验/NCT00886860
NCT00886860已完成4 期

The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Mahidol University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
64
试验地点
1
主要终点
success rate of cervical ripening in labor induction

研究概览

简要总结

The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

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
Triple (Participant, Care Provider, Investigator)

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

  • age 18 years old or more
  • singleton pregnancy at 37 weeks gestation or more
  • cephalic presentation
  • reassuring fetal heart rate pattern
  • admission for labor induction due to medical or obstetrical conditions
  • bishop score less than 6
  • giving consent and having signed the consent form for this study

排除标准

  • parity more than 3
  • estimated fetal weight more than 3,500 grams
  • non-reassuring fetal heart rate pattern
  • having contraindication for vaginal delivery
  • previous uterine scar
  • suspected abruptio placenta with non-reassuring fetal heart rate pattern
  • abnormal bleeding per vagina, except bloody show
  • having underlying cardiac, hepatic, or renal diseases
  • having history of allergy to misoprostol or prostaglandin analogues
  • cervical dilatation 3 centimeters or more
  • uterine contraction 3 times or more in 10 minute

研究组 & 干预措施

conventional oral misoprostol

Active Comparator

misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters

干预措施: misoprostol (Drug)

titrated oral misoprostol

Experimental

misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters

干预措施: misoprostol (Drug)

结局指标

主要结局

success rate of cervical ripening in labor induction

时间窗: 12 hours after intervention

次要结局

  • number of vaginal delivery(24 hours)

研究者

申办方类型
Other

研究点 (1)

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