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临床试验/NCT01242293
NCT01242293已完成不适用

Intrapartum Hydration

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Length of time from enrollment until delivery

研究概览

简要总结

The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.

详细描述

During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous women
  • Gestational age 37-41 weeks
  • Cervical dilatation 1-3 cm
  • Vertex presentation
  • Singleton

排除标准

  • Preeclampsia
  • Intra uterine fetal growth restriction
  • Duration of labor less than an hour
  • Maternal chronic disease
  • Maternal fever upon admission.

结局指标

主要结局

Length of time from enrollment until delivery

时间窗: within the first 48 hours after delivery

次要结局

  • Mode of delivery(within the first 48 hours after delivery)
  • Neonatal outcome(within the first 48 hours after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raed Salim

MD

HaEmek Medical Center, Israel

研究点 (1)

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