A Randomized Parallel Non-inferiority Trial to Evaluate the Safety and Efficacy of Levetiracetam in Comparison to Magnesium Sulfate in the Management of Severe Preeclampsia

Abstract

Aim: The study aimed to compare the safety and efficacy of levetiracetam to magnesium sulfate for the prevention of convulsions in preeclampsia. Materials and methods: A total of 60 women with preeclampsia with severe features were randomized to receive either levetiracetam or magnesium sulfate. In the levetiracetam group, a loading dose of 1000 mg/day (500 mg 12th hourly for 24 hours) was administered slowly over 5 minutes intravenously followed by an oral tablet of levetiracetam 500 mg 12th hourly for 5 days. In the magnesium sulfate group, 4 gm of magnesium sulfate was given IV over 3–5 minutes followed by a maintenance dose of 1 gm/hour for 24 hours. Magnesium sulfate solution was given in dilution via infusion pump. Results: This study shows that levetiracetam is non-inferior to magnesium sulfate as none of the patients in both arms had any convulsions. Conclusion: Levetiracetam is non-inferior to magnesium sulfate in the prevention of convulsions in preeclampsia. It can be used as an alternative to magnesium sulfate, especially when magnesium sulfate is contraindicated.