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

FDA Office of Orphan Products Development

Status: Completed

Conditions: Pre-eclampsia

Treatments: Drug: nimodipine; Drug: magnesium sulfate

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00004399

BCM-FDR001061

UU-FDR001061

199/13249

Details and patient eligibility

About

OBJECTIVES:

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

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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