Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

Study Overview
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Brief Summary
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Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Detailed Description
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Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.

Official Title
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Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial

Conditions
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Severe Preeclampsia

Intervention / Treatment
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* Drug: Magnesium sulfate 12 hours
* Drug: Magnesium sulfate 24 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-eclampsia; Puerperium. Exclusion Criteria: Associated maternal diseases; Use of illicit drugs or other medications that might interfere with maternal hemodynamics; Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 hours of magnesium sulfate<br>Patients in this group will have magnesium sulfate administered for 12 hours after delivery | Drug: Magnesium sulfate 12 hours<br>* Magnesium sulfate, 1g/h, (10% solution), for 12 hours<br>|
| Active Comparator: 24 hours of magnesium sulfate<br>Patients in this group will have magnesium sulfate administered for 24 hours after delivery | Drug: Magnesium sulfate 24 hours<br>* Magnesium sulfate, 1g/h, (10% solution), for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need to continue therapy for another 12 hours. | Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | Patients satisfaction with the duration of therapy | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe preeclampsia, magnesium sulfate, anticonvulsivant