NCT00004399已完成不适用
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
FDA Office of Orphan Products Development0 个研究点目标入组 2,000 人开始时间: 1995年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
研究概览
简要总结
OBJECTIVES:
I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
详细描述
PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.
Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.
Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria:
- •Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg
- •Proteinuria greater than 5 g/24 hr
- •Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L
- •Severe headache and/or scotomata
- •Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr)
- •Pulmonary edema
- •-Prior/Concurrent Therapy--
- •No prior/concurrent magnesium sulfate or dihydropyridine agents
- •No other concurrent antiseizure medications
- •-Patient Characteristics--
- •Age: Not specified
- •Performance status: Not specified
- •Hematopoietic: See Disease Characteristics
- •Hepatic: See Disease Characteristics
- •Renal: No severe renal failure See Disease Characteristics
- •Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics
- •Pulmonary: See Disease Characteristics
- •No severe mental or physical disorder that may affect therapy
- •Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate
- •No evidence of fetal distress or fetal anomalies
排除标准
- 未提供
研究者
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