search
Back to results

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

Primary Purpose

Pre-eclampsia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
magnesium sulfate
nimodipine
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-eclampsia focused on measuring cardiovascular and respiratory diseases, hypertensive disorder, pre-eclampsia, rare disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    University of Utah
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00004399
    Brief Title
    Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2000 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    University of Utah

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-eclampsia
    Keywords
    cardiovascular and respiratory diseases, hypertensive disorder, pre-eclampsia, rare disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    2000 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    magnesium sulfate
    Intervention Type
    Drug
    Intervention Name(s)
    nimodipine

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Anthony Belfort
    Organizational Affiliation
    University of Utah
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs