IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
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 June 23, 2017