Randomized Controlled Trial Comparing Two Different Regimes of Magnesium Sulphate in Severe Pre-eclampsia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JIPMER
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Development of Eclampsia defined as new-onset grand mal seizures in a woman with preeclampsia
研究概览
简要总结
Use of magnesium sulphatefor the prevention of eclampsia, popularized by the Magpie trial, has been ableto decrease the mortality and morbidity of women with pre-eclampsia. Experience using theshorter regimes for seizure prevention has been reported in women witheclampsia; however use for seizure prophylaxis in preeclampsia is limited worldliterature. There are no such studies reported from Indian subcontinent. So we plan to conduct to conduct a randomized control studycomparing the commonly used regimes for seizure prophylaxis. We plan this study with the hypotheisis that "Parenteralloading dose only regime is equally effective and more safe than theconventional low dose regime ofmagnesium sulphate for the prevention ofeclampsia in women with sever preeclampsia".
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研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢Any pregnant woman with Severe Pre- eclampsia as per the ACOG Criteria: oSystolic blood pressure of 160 mm Hg or higher or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 6 hours apart.
- •oProteinuria of 5 gm or higher in a 24-hour urine specimen or 3+ or greater on two random urine samples collected at least 4 hours apart.
- •oOliguria of less than 500 ml in 24 hours.
- •oCerebral or visual disturbances oPulmonary edema or cyanosis oEpigastric or right upper-quadrant pain oImpaired liver function oThrombocytopenia oFetal growth restriction.
排除标准
- •oMultiple Pregnancy oPlatelet count < 50,000/mm3 oPlasma creatinine value ≥ 2mg/dl oComatose patients oDeranged coagulation profile oKnown case of myasthenia gravis oKnown case of seizure disorder oPatients with Eclampsia (defined as presence of new-onset grand mal seizures in a woman with preeclampsia).
- •oHypersensitivity to Magnesium.
- •oWomen who have received have received magnesium sulphate therapy before being referred.
结局指标
主要结局
Development of Eclampsia defined as new-onset grand mal seizures in a woman with preeclampsia
时间窗: Within 48 hours postpartum
次要结局
- Maternal Death(o Serious Maternal Morbidity)