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

Condition	Treatment or Intervention
Pre-Eclampsia	Drug: magnesium sulfate  Drug: nimodipine

Further Study Details: 

Expected Total Enrollment:  2000

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.

Genders Eligible for Study:  Female

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

Study chairs or principal investigators

Michael Anthony Belfort,  Study Chair,  University of Utah   

Study ID Numbers:  199/13249; UU-FDR001061; BCM-FDR001061
Record last reviewed:  January 2001
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004399
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08