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

Pre-eclampsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004399
• Other study ID #: 199/13249
• Secondary ID: UU-FDR001061BCM-
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: September 1995
• Est. completion date: August 2000

Study information

• Verified date: January 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: August 2000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• magnesium sulfate

• nimodipine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development	University of Utah