Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
magnesium sulfate
+ nimodipine
Urogenital Diseases+10
+ Cardiovascular Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Prevention Study
Summary
Study start date: September 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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