Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486025
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
ALTERNATE DOSING PROTOCOL FOR MAGNESIUM SULFATE IN OVERWEIGHT AND OBESE WOMEN WITH PREECLAMPISA A RANDOMIZED CONTROLLED TRIAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
There is still no evidence of the appropriate dose to be used Serum magnesium sulfate concentration is not measured regularly thus we may be using sub-therapeutic level or reaching a toxic levelOverweight and obese women have different pharmacokinetics and different drug distribution therefore they may need higher doses of magnesium sulfate to reach therapeutic level
Detailed Description:
Magnesium sulfate is used in pre-eclampsia to prevent seizures it is administered in the form of a loading dose and maintenance dose Maintenance dose of magnesium sulfate in pre-eclampsia varies in literature 1-3gmshour There is still no evidence of the appropriate dose to be used Serum magnesium sulfate concentration is not measured regularly thus we may be using sub-therapeutic level or reaching a toxic levelOverweight and obese women have different pharmacokinetics and different drug distribution therefore they may need higher doses of magnesium sulfate to reach therapeutic level This study will evaluate whether overweight and obese women need higher maintenance doses to reach therapeutic level of magnesium sulfate in serumPreeclampsia is a serious pregnancy complication characterized by hypertension proteinuria and signs of damage to another organ system often the kidneys occurring after 20 weeks of gestation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None