Continuation Versus Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- occurrence of convulsions
研究概览
简要总结
All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two groups:
Group I ( 50 cases) No magnesium sulfate received postpartum and Group II ( 50 cases)-magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour
详细描述
All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two equal groups:
Group I is the study group: No post partum magnesium sulfate doses were given. Group II is the control group where magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with severe preeclampsia
- •Severe features of preeclampsia include any of the following findings: systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before that time),thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema or new onset cerebral or visual disturbances
排除标准
- •severe preeclampsia with serum creatinine[1.2 mg/dl
- •previous history of eclampsia
- •Associated maternal medical diseases: pre-existing diabetes mellitus, epilepsy, renal disease.
- •Renal insufficiency.
- •anuric or oliguric urinary out-put under 25 mL/hour.
- •contraindication to the use of magnesium sulfate such as known hypersensitivity to the drug
- •Those with evident hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome
研究组 & 干预措施
MgSO4 discontinuation
after delivery , no Extradoses of MgSO4 were given
干预措施: Magnesium Sulfate (Drug)
MgSO4 continuation
After delivery , Mg Sop4 was given at a rate of 1 gram /hour for 24 hours after delivery
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
occurrence of convulsions
时间窗: 48 hours after delivery
occurrence of eclamptic fits postpartum
次要结局
未报告次要终点