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临床试验/NCT02859571
NCT02859571Unknown2 期

Continuous Versus Intermittent Oxytocin for Induction of Labor: A Randomized Study

Zeynep Kamil Maternity and Pediatric Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
200
试验地点
1
主要终点
induction-to-delivery time

研究概览

简要总结

This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin.

详细描述

In the continuous oxytocin group, traditional treatment of oxytocin used at a starting dose of 1-2 mIU/min and the dose was increased by 2 mIU/min at every 15 minutes until regular contractions obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin was 40 mIU/min and oxytocin was administered until delivery. In the intermittent group, oxytocin was discontinued when cervical dilation was 5 cm and 2 hours after discontinuation oxytocin was reused at a starting dose of 1-2 mIU/min and was increased as the same protocol used for continuation oxytocin group.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy,
  • 37≤ weeks of gestational age ,
  • vertex presentation,
  • women with cervical dilation 3 cm
  • no contraindication to vaginal delivery.

排除标准

  • fetal malpresentation,
  • multifetal pregnancy,
  • more than three contractions in 10 minutes,
  • contraindications to oxytocin,
  • a category II or III fetal heart rate pattern,
  • fetal anomaly,
  • fetal demise
  • women with immediate delivery indications

研究组 & 干预措施

Continuous oxytocin

Active Comparator

oxytocin will be used at a starting dose of 1-2 mIU/min and the dose will be increased by 2 mIU/min at every 15 minutes until regular contractions will be obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin will 40 mIU/min and oxytocin will be administered until delivery.

干预措施: Oxytocin (Drug)

intermittent oxytocin

Experimental

oxytocin will be discontinued when cervical dilation will 5 cm and 2 hours after discontinuation oxytocin will be reused at a starting dose of 1-2 mIU/min and will be increased as the same protocol will be used for continuation oxytocin group.

干预措施: Oxytocin (Drug)

结局指标

主要结局

induction-to-delivery time

时间窗: intraoperative

次要结局

未报告次要终点

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Eser

medical doctor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (1)

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