Safety and Efficacy of Twelve Hours Duration of Magnesium Sulphate in the Treatment of Eclampsia in Low Resource Setting in Sudan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients who will receive magnesium sulfate and develop drug toxicity
研究概览
简要总结
the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.
详细描述
The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of eclampsia
- •must accept to participate in the study
排除标准
- 未提供
研究组 & 干预措施
group 1
group one will be treated with 24 hours maintenance dose of magnesium sulphate
干预措施: Adminstration of magnesium Sulphate for treatment of eclampsia (Drug)
group 2
group 2 will be treated with 12 hours maintenance dose of magnesium sulphate
干预措施: Adminstration of magnesium Sulphate for treatment of eclampsia (Drug)
结局指标
主要结局
Number of patients who will receive magnesium sulfate and develop drug toxicity
时间窗: 12 - 24 hours
the adverse effect of magnesium sulphate either minor signs:flushing, increased warmth and sweating, nausea, vomiting, headaches, muscle weakness and blurred vision or major effects such as absent tendon reflexes and oliguria.
次要结局
未报告次要终点
研究者
AbdelAziem AbdAllah Ali
Prof.
Gadarif University