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

Sponsor

FDA Office of Orphan Products Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00004399

Collaborator

University of Utah (Other)

2,000

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES:

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

Condition or Disease	Intervention/Treatment	Phase
Pre-eclampsia	Drug: magnesium sulfate Drug: nimodipine	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Prevention

Study Start Date :

Sep 1, 1995

Study Completion Date :

Aug 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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