Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
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ClinicalTrials.gov Identifier: NCT00004399 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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OBJECTIVES:
I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pre-eclampsia | Drug: magnesium sulfate Drug: nimodipine | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 2000 participants |
Allocation: | Randomized |
Primary Purpose: | Prevention |
Study Start Date : | September 1995 |
Study Completion Date : | August 2000 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004399
Study Chair: | Michael Anthony Belfort | University of Utah |
ClinicalTrials.gov Identifier: | NCT00004399 |
Other Study ID Numbers: |
199/13249 UU-FDR001061 BCM-FDR001061 |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | January 2001 |
cardiovascular and respiratory diseases hypertensive disorder pre-eclampsia rare disease |
Eclampsia Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Magnesium Sulfate Nimodipine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics |
Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents Reproductive Control Agents Antihypertensive Agents Vasodilator Agents |