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

This study has been completed.

Sponsor:

Collaborator:

University of Utah

Information provided by:

FDA Office of Orphan Products Development

ClinicalTrials.gov Identifier:

NCT00004399

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: January 2001

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: preeclampsia

MedlinePlus related topics: High Blood Pressure Seizures

Drug Information available for: Magnesium Magnesium sulfate Sulfate ion

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Additional relevant MeSH terms:


Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Magnesium Sulfate Analgesics Anesthetics Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents	Central Nervous System Depressants Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Sensory System Agents Therapeutic Uses Tocolytic Agents

ClinicalTrials.gov processed this record on February 27, 2015

To Top