Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
This study has been completed.
Sponsor:
FDA Office of Orphan Products Development
Collaborator:
University of Utah
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004399
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2001
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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 |
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004399
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004399
Sponsors and Collaborators
FDA Office of Orphan Products Development
University of Utah
Investigators
| Study Chair: | Michael Anthony Belfort | University of Utah |
More Information
| 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: | March 24, 2015 |
| 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 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 Tocolytic Agents Reproductive Control Agents Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on September 29, 2016