Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia

NCT00004399 | Completed

• 3 other identifiers: 199/13249UU-FDR001061BCM-FDR001061
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.

Conditions

Pre-eclampsia

Keywords

cardiovascular and respiratory diseases; hypertensive disorder; pre-eclampsia; rare disease

Interventions

magnesium sulfate DRUG

nimodipine DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead
• University of Utah: collaborator

MeSH Terms

Conditions

Pre-Eclampsia; Respiratory Tract Diseases; Hypertension; Rare Diseases

Interventions

Magnesium Sulfate; Nimodipine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids

Study Officials

• Michael Anthony Belfort

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: September 1, 1995
• Study Completion: August 1, 2000
• Last Updated: March 25, 2015

Record last verified: 2001-01