跳至主要内容
临床试验/CTRI/2024/05/066966
CTRI/2024/05/066966招募中Phase 3 4

Randomised control trial for comparison of 12hours v/s 24 hours post-partum maintenance therapy of magnesium sulphate in severe pre- eclampsia and eclampsia patients’

Pramukhswami medical college1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
入组人数
198
试验地点
1
主要终点
To determine the recurrence of convlsions in patients receiving 12hrs/24hrs maintenance dose of magnesium sulphate

研究概览

简要总结

Magnesium sulphate is a drug of choice for severe pre eclampsia and eclampasia  patients. As per standard protocol this drug is given as an loading dose 4gm inta venous followed by maintenance dose for 24 hours ,but this standard protocol is made by western country and we are also followed it. As our Indian women having weight less than western country so the need of dose is lesser in India. Many studies are done in India and are found significant.In this study loading dose of magnesium 4gm intavenous followed by maintennace dose 1gm per hour intravenous for a duration of 12hours instant of 24hrs by randomised control trial.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women with severe pre-eclapsia and eclampsia admitted to OBGY department PSMC,karmsad.

排除标准

  • Status eclampicus Renal compromise Patient recieve other anti convulsant except magnesium sulphate.

结局指标

主要结局

To determine the recurrence of convlsions in patients receiving 12hrs/24hrs maintenance dose of magnesium sulphate

时间窗: To determine the recurrence of convlsions in patients receiving 12hrs/24hrs maintenance dose of magnesium sulphate

次要结局

  • maternal morbidity(Respiratory failure,ICU admission,total hospital stay,hospital acquired infection.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

sunita pandya

PSMC karmsad anand

研究点 (1)

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