Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004399
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia
I Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia
Detailed 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCM-FDR001061 | None | None | None |
| UU-FDR001061 | None | None | None |