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临床试验/NCT05553756
NCT05553756进行中(未招募)不适用

Impact of Maltodextrin, Given 2 Hours Before Cesarean Section, on Glycemic and Hemodynamic Management of Pregnant

University of Foggia2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
2
主要终点
Glycemic stability

研究概览

简要总结

The goal is to evaluate the glycemic and hemodynamic stability in patients undergoing caesarean section in patients treated with maltodextrins two hours before the cesarean section

详细描述

The patients undergoing elective cesarean section will be randomly divided in two groups: patients who drink 200 ml of clear liquid two hours before surgery or patients treated with 200 ml maltodextrins two hours before the surgery. The glycemic control will be done immediately before the maldodextrin administration and after the cesarean section by gluco stick. Standard hemodynamic monitoring ECG, Heart Rate, Blood pressure, Temperature, preipheral oxygen saturation will be done routinely.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

  • informed consent
  • first cesarean section
  • single fetus

排除标准

  • contraindication to spinal anesthesia
  • cardiovascular diseases

结局指标

主要结局

Glycemic stability

时间窗: perioperative

blood glucose levels \<180 mg/dl

hemodynamic stability

时间窗: perioperative

mean arterial pressure \> 70 mmHg during perioperative time

次要结局

未报告次要终点

研究者

发起方
University of Foggia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cotoia Antonella

Clinical Professor

University of Foggia

研究点 (2)

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