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

NCT ID: NCT00004399

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-09-30
• Study Completion Date: 2000-08-31

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.

Conditions

Pre-eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION

Interventions

magnesium sulfate

Intervention Type: DRUG

nimodipine

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

FDA Office of Orphan Products Development

FED

Sponsor Role: lead

Principal Investigators

Michael Anthony Belfort

Role: STUDY_CHAIR

University of Utah

Other Identifiers

UU-FDR001061

Identifier Type: -

Identifier Source: secondary_id

BCM-FDR001061

Identifier Type: -

Identifier Source: secondary_id

199/13249

Identifier Type: -

Identifier Source: org_study_id