Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344058
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2006-06-23
Brief Title:
Abbreviated MgSO4 Therapy in Post-partum Preeclampsia
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia A Comparison of 12 and 24 Hour Regimens
Status:
COMPLETED
Status Verified Date:
2005-08
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:
Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia There is debate as to how long to continue this therapy after delivery of the pregnancy Different schemes have been offered to shorten the exposure to magnesium sulfate after delivery with little data We seek to investigate the effect of shortened magnesium sulfate therapy on the post-partum recovery phase of mild preeclampsia Our hypothesis was that shortened therapy 12 hours versus the traditional 24 hours post-partum has no effect on disease course and will result in significantly shorter exposure to magnesium sulfate
Detailed Description:
The study has been completed at this time
Consenting women with suspected mild preeclampsia new onsetexacerbated hypertension with proteinuria were randomly assigned 12 12-hour or 24-hours 24-hour of postpartum MgSO4 Treatment was continued beyond the initially assigned time period for new findings of severe preeclampsia Clinical and laboratory data were collected Analysis was by intent to treat utilizing Fishers exact chi-square and Students t-tests where appropriate
Consenting women with suspected mild preeclampsia new onsetexacerbated hypertension with proteinuria were randomly assigned 12 12-hour or 24-hours 24-hour of postpartum MgSO4 Treatment was continued beyond the initially assigned time period for new findings of severe preeclampsia Clinical and laboratory data were collected Analysis was by intent to treat utilizing Fishers exact chi-square and Students t-tests where appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None