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临床试验/NCT03489798
NCT03489798已完成不适用

Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.

Saint Thomas Hospital, Panama2 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2018年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
310
试验地点
2
主要终点
Vaginal birth

研究概览

简要总结

To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.

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

性别
Female
接受健康志愿者

入选标准

  • Pregnant women between 34 and 42 weeks of gestation.
  • Obstetric indication for termination of pregnancy.
  • No fetal evidence of fetal distress

排除标准

  • Any contraindication for the use of misoprostol.
  • Oligohydramnios.

结局指标

主要结局

Vaginal birth

时间窗: 48 hours

Number of patients that had a vaginal birth

次要结局

  • Maternal complications(48 hours)
  • Fetal complications(48 hours)

研究者

发起方
Saint Thomas Hospital, Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osvaldo A. Reyes T.

Investigator - Head: Research Department

Saint Thomas Hospital, Panama

研究点 (2)

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