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临床试验/NCT04046510
NCT04046510已完成不适用

Comparaison of 3 Protocols of Ocytocin Administration in Cesarean Section

Mongi Slim Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
uterine tone

研究概览

简要总结

This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia

详细描述

This study aimed to compare 3 doses of ocytocin in bolus injection and contnious perfusion during C section. these doses determined by: high, intermediate and low doses, were administred to parturients during elective or urgent C section under spinal anesthesia.

The aim was to determine the lowest efficient dose to prevent post partum hemorrage and with the lowest incidence of maternal side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

pre filled syringues of ocytocin were given to the care provider who didn't know the exact amount of ocytocin bolus and continious infusion

入排标准

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

入选标准

  • All adult patients scheduled for C section under spinal anesthesia, monofoetal pregnancy, full term

排除标准

  • necessity of general anesthesia
  • non conscent

研究组 & 干预措施

High doses

Active Comparator

the patients of this group recieved conventionnal doses of ocytocin after foetal extraction in C section: 5IU in bolus followed by 15IU in continuous infusion

干预措施: Ocytocin (Drug)

Intermediate doses

Experimental

the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 10IU in continuous infusion

干预措施: Ocytocin (Drug)

Low doses

Experimental

the patients of this group recieved after foetal extraction in C section: 2IU in bolus followed by 5 IU in continuous infusion

干预措施: Ocytocin (Drug)

结局指标

主要结局

uterine tone

时间窗: 10 minutes

uterine tone juged by the obstetrician

次要结局

  • hemoglobin rate(30 minutes after C section)
  • side effects of Ocytocin(up to 30 minutes after C section)
  • Additive boluses of Ocytocin(30 minutes after C section)

研究者

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

Mhamed Sami Mebazaa

Professor head of the anesthesia and intensive care department

Mongi Slim Hospital

研究点 (1)

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