Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Need to continue therapy for another 12 hours.
研究概览
简要总结
Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.
详细描述
Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-eclampsia;
- •Puerperium.
排除标准
- •Associated maternal diseases;
- •Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
- •Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
研究组 & 干预措施
12 hours of magnesium sulfate
Patients in this group will have magnesium sulfate administered for 12 hours after delivery
干预措施: Magnesium sulfate 12 hours (Drug)
24 hours of magnesium sulfate
Patients in this group will have magnesium sulfate administered for 24 hours after delivery
干预措施: Magnesium sulfate 24 hours (Drug)
结局指标
主要结局
Need to continue therapy for another 12 hours.
时间窗: 24 hours
Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.
次要结局
- Satisfaction(24 hours)
研究者
Leila Katz
Obstetrical ICU obstetrical coordinator; MD , PhD
Instituto Materno Infantil Prof. Fernando Figueira