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临床试验/NCT01022697
NCT01022697已完成不适用

Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth

University Hospital, Caen9 个研究点 分布在 1 个国家目标入组 4,142 人开始时间: 2008年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4,142
试验地点
9
主要终点
Instrumental extraction rates

研究概览

简要总结

Fear of full stomach when emergency general anaesthesia is required is the origin of fastening when giving birth. This behaviour does not warranty perfect security for the general anaesthesia. In addition, well being for women and new born is affected. Giving birth is finally compared to a sportive competition with high-energy needs. As Intravenous energy intake is not regulated by physiologic digestion, it can induce metabolic disorders for the mother that can be amplified for the foetus.

Oral glucose drinks could offer some benefits:

  • gastric acidity would be decreased without significant increase in volumes.
  • energy intake would further more active and more efficiency labour
  • an increase in foetus well being

However, it has never been shown yet that such behaviour could offer those benefits. Also, it seems that there is not more vomiting, but most of the studies compared oral glucose intake to waterborne intake with the same volumes The expected efficacy is a reduction in labour duration and a reduction in percentage of extraction. Previous studies said that the lack of statistical power due to small number of subjects caused the absence of statistical significant relationship.

In addition, even though newborn have less acidosis, there is no clinical relationship proven.

The investigators propose a randomised multicentre study to assess efficacy of oral glucose drinks in comparison to traditional fastening when giving birth.

Main objective is to significantly reduce instrumental extraction rates. 5400 women will be included in the study in 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age >= 18 yrs
  • •Entering for childbirth
  • •Informed written consent

排除标准

  • •more of 8 cm of dilatation
  • •Caesarean section planned
  • •natural delivery non-indicated
  • •pre-partum hemostasis troubles
  • •salicylic acid or anticoagulant treatment
  • •pre-eclampsia or HELLP syndrome
  • •diabetic neuropsy with troubles in gastric emptying
  • •IMC > 40 at the end of pregnancy
  • •understanding of the information
  • •under guardianship

研究组 & 干预措施

A

Active Comparator

Glucose drink

干预措施: Glucose drink (Other)

B

No Intervention

Fasting

结局指标

主要结局

Instrumental extraction rates

时间窗: During childbirth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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