Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
magnesium sulfate
+ nimodipine
Enfermedades Urogenitales+7
+ Enfermedades Cardiovasculares
+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo
Estudio de Prevención
Resumen
Fecha de inicio: 1 de septiembre de 1995
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 2000 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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