Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial

Study Overview
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Brief Summary
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All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two groups: Group I ( 50 cases) No magnesium sulfate received postpartum and Group II ( 50 cases)-magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Detailed Description
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All women with severe preeclmapsia were given a loading dose of 4 g magnesium sulfate IV followed by the maintenance dose of 1 g/h infusion till the delivery. After delivery, women who received magnesium sulfate for 8 hours or more were randomly divided into two equal groups: Group I is the study group: No post partum magnesium sulfate doses were given. Group II is the control group where magnesium sulfate infusion is given for conventional 24 h postpartum at a rate of 1 gm per hour

Official Title
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Continuation Versus Discontinuation of Magnesium Sulfate After Delivery in Women With Severe Preeclampsia. A Randomized Controlled Trial

Conditions
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Preeclampsia Severe

Intervention / Treatment
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* Drug: Magnesium Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with severe preeclampsia Severe features of preeclampsia include any of the following findings: systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before that time),thrombocytopenia, impaired liver function, progressive renal insufficiency, pulmonary edema or new onset cerebral or visual disturbances Exclusion Criteria: - severe preeclampsia with serum creatinine[1.2 mg/dl 2. previous history of eclampsia 3. Associated maternal medical diseases: pre-existing diabetes mellitus, epilepsy, renal disease. 4. Renal insufficiency. 5. anuric or oliguric urinary out-put under 25 mL/hour. 6. contraindication to the use of magnesium sulfate such as known hypersensitivity to the drug 7. Those with evident hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MgSO4 discontinuation<br>after delivery , no Extradoses of MgSO4 were given | Drug: Magnesium Sulfate<br>* Intravenous ampules of MgSo4 was given to only to control group after delivery<br>* Other names: MgSO4;|
| Active Comparator: MgSO4 continuation<br>After delivery , Mg Sop4 was given at a rate of 1 gram /hour for 24 hours after delivery | Drug: Magnesium Sulfate<br>* Intravenous ampules of MgSo4 was given to only to control group after delivery<br>* Other names: MgSO4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of convulsions | occurrence of eclamptic fits postpartum | 48 hours after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, Magnisium sulfate