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

• Status: Completed
• Trial end date: 2000-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

OBJECTIVES:

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborator: University of Utah
• Treatments: Magnesium Sulfate; Nimodipine

Criteria

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