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

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development University of Utah
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004399

Purpose

OBJECTIVES:

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

Condition	Intervention
Pre-Eclampsia	Drug: magnesium sulfate Drug: nimodipine

Genetics Home Reference related topics: pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Magnesium sulfate Nimodipine Magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	2000
Study Start Date:	September 1995
Estimated Study Completion Date:	August 2000

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004399

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Utah

Investigators

Study Chair:

Michael Anthony Belfort

University of Utah

More Information

No publications provided

Study ID Numbers:	199/13249, UU-FDR001061, BCM-FDR001061
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004399 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cardiovascular and respiratory diseases
hypertensive disorder
pre-eclampsia
rare disease

Study placed in the following topic categories:

Vasodilator Agents
Pregnancy Complications
Eclampsia
Magnesium Sulfate
Respiration Disorders
Seizures
Rare Diseases
Calcium Channel Blockers
Central Nervous System Depressants
Anesthetics
Pre-Eclampsia

Cardiovascular Agents
Antihypertensive Agents
Preeclampsia
Calcium, Dietary
Hypertension, Pregnancy-Induced
Nimodipine
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents
Anticonvulsants
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Magnesium Sulfate
Physiological Effects of Drugs
Pre-Eclampsia
Anesthetics
Calcium Channel Blockers
Reproductive Control Agents
Membrane Transport Modulators
Hypertension, Pregnancy-Induced
Tocolytic Agents
Sensory System Agents

Therapeutic Uses
Nimodipine
Analgesics
Anti-Arrhythmia Agents
Eclampsia
Central Nervous System Depressants
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009