Efficacy and Safety of 1 g Vs 2 g Per Hour Intravenous Maintenance Dose of MgSO4 in Women With Severe Pre-eclampsia
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|ClinicalTrials.gov Identifier: NCT03164304|
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Severe Preeclampsia||Drug: Magnesium Sulfate||Phase 4|
Treatment for patients who have developed preeclampsia or eclampsia mainly consists of control of hypertension, magnesium sulphate for prevention of eclampsia and convulsions, and planning for delivery.
Magnesium sulfate has been used to prevent eclamptic convulsion since 1925, its efficacy was confirmed by a large randomized controlled trial in 2002. Eclampsia could be prevented in more than 50% after magnesium sulfate administration . The World Health Organization recommended magnesium sulfate as the most effective, safe, and low-cost drug for the prevention of seizure in severe preeclampsia and eclampsia . The recommended dose of magnesium sulfate is 4 to 6 gram intravenous loading dose, followed by maintenance intravenous drip at the rate of 1 to 2 gram per hour .
Although different magnesium sulfate regimens have been tested, two dosing regimens are internationally recommended and widely used. The Pritchard regimen is a predominantly intramuscular regimen given as a loading dose of 4 g intravenously , and 5 g Intramuscular into each buttock followed by a maintenance dose of 5 g Intramuscular every 4 hours. This regimen is popular in resource-limited settings where intravenously administration of magnesium sulfate may not be feasible. However, it is associated with pain and a higher risk of infection at the injection site.
The Zuspan regimen is given as a 4 gram intravenously loading dose followed by continuous intravenously infusion of 1 gram per hour.
Either 1 gram or 2 gram maintenance dose of Magnesium Sulphate has been reported to reduce the development of eclampsia. Randomized controlled trials offering direct comparison between these 2 doses are lacking.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of One Gram Versus Two Grams Intravenous Maintenance Dose of Magnesium Sulfate in Women With Severe Pre-eclampsia: a Randomized Clinical Trial.|
|Actual Study Start Date :||May 30, 2017|
|Actual Primary Completion Date :||January 30, 2020|
|Actual Study Completion Date :||January 30, 2020|
Active Comparator: One gram magnesium sulfate
Pregnant women with a diagnosis of severe pre-eclampsia will receive 1 g of mgso4 to prevent and control of convulsions
Drug: Magnesium Sulfate
Experimental: Two grams magnesium sulfate
Pregnant women with a diagnosis of severe pre-eclampsia will receive 2 g of mgso4 to prevent and control of convulsions
Drug: Magnesium Sulfate
- The rate of convulsions in each group. [ Time Frame: 24 hour ]the number of participants who have convulsion
- The percentage of women reaching the Mg therapeutic level of 4,8 mg/dl [ Time Frame: 24 hour ]Follow up by Serum Magnesium level
- The rate of adverse events in each group [ Time Frame: 24 hour ]the number of participants who have adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164304
|Assiut University, woman health hospital|