Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
OBJECTIVES:

 I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of
 eclamptic seizures in patients with severe preeclampsia.
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.
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

 --Other:--

 -  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