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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
  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:


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
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:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Nimodipine
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Antihypertensive Agents
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
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014