Pre-eclampsia
Conditions
Keywords
cardiovascular and respiratory diseases, hypertensive disorder, pre-eclampsia, rare disease
Brief summary
OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
Detailed description
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.
Interventions
DRUGmagnesium sulfate
DRUGnimodipine
Sponsors
University of Utah
FDA Office of Orphan Products Development
Study design
Allocation
RANDOMIZED
Primary purpose
PREVENTION
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion 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
Outcome results
None listed