COMPARISION OF TWO REGIMENS OF LOW DOSE MAGNESIUM SULPHATE FOR TREATMENT OF ECLAMPSIA: LOADING PLUS 24-HOUR MAINTENANCE DOSE VERSUS LOADING DOSE ONLY
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The outcomes of two regimens are compared in terms of
研究概览
简要总结
This study is a randomised, parallel group, open lebel trial compairing the efficacy of two regimens of low dose magnesium sulphate for the treatment of eclapsia in Indian women. In this trial, two regimens of (low dose) magnesium sulphate in the treatment of eclampsia are compared.
(1) In Control Group: low dose magnesium sulphate (loading plus maintenance dose) is used to control convulsions.
(2) In STUDY Group: Only loading dose of magnesium sulphate will be used (no maintenance dose) for control of convulsions.
The outcomes of study and control groups are compared in terms of:
(a) Rate of recurrent convulsions in mothers.
(b) Maternal mortality and morbidity
(c) Total amount of magnesium sulphate received by each woman.
(d) Clinical evidence of magnesium toxicity.
(e) Perinatal mortality and morbidity
This study will explore how efficiently magnesium sulphate can be used for eclampsia without producing maternal toxicity, and avoiding undue prolonged treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All cases of eclampsia – antepartum, intrapartum, postpartum with following diagnostic criteria: a)Hypertension where BP 140/90 mm Hg or more b)Proteinuria (more than 0.3g/L or more than + 1) c)Convulsion occurring at gestational age > 20 weeks, or within 48 h of delivery.
排除标准
- •Eclampsia with the following conditions will be excluded: a.Renal failure b.Deeply comatosed c.Hypotensive patient d.Clinical or imaging evidence suggestive of intracranial haemorrhage e.Diagnosis is doubtful f.Patients who had other causes of convulsions such as epilepsy, meningitis, trauma, and cerebral malaria etc.
结局指标
主要结局
The outcomes of two regimens are compared in terms of
时间窗: Till discharge
a)Rate of recurrent convulsions
时间窗: Till discharge
b)Maternal mortality
时间窗: Till discharge
次要结局
- 1. Magnesium Sulphate – a)Total amount of magnesium sulphate received by each patient with or without maintenance dose(b) Total no. of maintenance dose received)