OBJECTIVES:

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

Study Type: Interventional

Study Design: Prevention, Randomized

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.

Intervention(s) in this Clinical Trial

• Drug: magnesium sulfate
• Drug: nimodipine

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: FDA Office of Orphan Products Development

Overall Clinical Trial Officials and Contacts

Michael Anthony Belfort Study Chair University of Utah  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004399

Study ID Number: 199/13249

ClinicalTrials.gov Identifier: NCT00004399

Health Authority: United States: Federal Government