Journal of South Asian Federation of Obstetrics and Gynaecology

Register      Login

VOLUME 14 , ISSUE 3 ( May-June, 2022 ) > List of Articles

RESEARCH ARTICLE

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

Rajasri G Yaliwal, Aruna M Biradar, Sangamesh B Bhagavati, Shreedevi S Kori, Subhashchandra R Mudanur

Keywords : Anticonvulsants, Levetiracetam, Magnesium Sulfate, Preeclampsia, Seizure

Citation Information : Yaliwal RG, Biradar AM, Bhagavati SB, Kori SS, Mudanur SR. 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. J South Asian Feder Obs Gynae 2022; 14 (3):287-291.

DOI: 10.5005/jp-journals-10006-2046

License: CC BY-NC 4.0

Published Online: 27-07-2022

Copyright Statement:  Copyright © 2022; The Author(s).


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.


PDF Share
  1. Handa S, Pujar Y. Evaluation of uterine artery Doppler at 11–13+6 weeks of gestation for prediction of preeclampsia: a descriptive observational study. J South Asian Feder Obstet Gynaecol 2019;11(5):305–308. DOI: 10.5005/jp-journals-10006-1721.
  2. Rajesh A, Suresh A, Muralidharan V. Serum lipid profile in second trimester as a predictor of gestational hypertension. J South Asian Feder Obstet Gynaecol 2020;12(1):23–26. DOI: 10.5005/jp-journals-10006-1750.
  3. Bhattacharjee N, Saha SP, Ganguly RP, et al. A randomised comparative study between low-dose intravenous magnesium sulphate and standard intramuscular regimen for treatment of eclampsia. Journal of Obstetrics and Gynaecology 2011;31(4):298–303. DOI: 10.3109/01443615.2010.549972.
  4. Gestational hypertension and preeclampsia: ACOG practice bulletin, Number 222. Obstet Gynecol 2020;135(6):e237–e260. DOI: 10.1097/AOG.0000000000003891.
  5. Keepanasseril A, Maurya DK, Manikandan K, et al. Prophylactic magnesium sulphate in prevention of eclampsia in women with severe preeclampsia: randomised controlled trial (PIPES trial). J Obstet Gynaecol 2018;38(3):305–309. DOI: 10.1080/01443615.2017.1351931.
  6. Khooshideh M, Ghaffarpour M, Bitarafan S. The comparison of anti-seizure and tocolytic effects of phenytoin and magnesium sulphate in the treatment of eclampsia and preeclampsia: a randomised clinical trial. Iran J Neurol 2017;16(3):125–129. PMID: 29114367.
  7. Fogleman CD. Magnesium sulfate and other anticonvulsants for women with preeclampsia. Am Fam Physician 2011;83(11):1269–1270. PMID: 21661707.
  8. Koc G, Keskin Guler S, Karadas O, et al. Fetal safety of levetiracetam use during pregnancy. Acta Neurol Belg 2018;118(3):503–508. DOI: 10.1007/s13760-018-0996.
  9. Duley L, Gülmezoglu AM, Chou D. Magnesium sulphate versus lytic cocktail for eclampsia. Cochrane Database Syst Rev 2010;2010(9):CD002960. DOI: 10.1002/14651858.CD002960.pub2.
  10. Duley L, Gülmezoglu AM, Henderson-Smart DJ. Magnesium sulphate and other anticonvulsants for women with pre-eclampsia. Cochrane Database Syst Rev 2003;(2):CD000025. DOI: 10.1002/14651858.CD000025 [Update in: Cochrane Database Syst Rev. 2010;(11):CD000025. PMID: 12804383].
  11. Duley L, Henderson-Smart DJ, Walker GJ, et al. Magnesium sulphate versus diazepam for eclampsia. Cochrane Database Syst Rev 2010;12:CD000127. DOI: 10.1002/14651858.CD000127.pub2.
  12. Sibai BM. Magnesium sulfate prophylaxis in preeclampsia: lessons learned from recent trials. Am J Obstet Gynecol 2004;190(6): 1520–1526. DOI: 10.1016/j.ajog.2003.12.057.
  13. Weston J, Bromley R, Jackson CF, et al. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev 2016;11(11):CD010224. DOI: 10.1002/14651858.CD010224.pub2.
  14. De Jesus LC, Sood BG, Shankaran S, et al. Antenatal magnesium sulfate exposure and acute cardiorespiratory events in preterm infants. Am J Obstet Gynecol 2015;212(1):94.e1–94.e947. DOI: 10.1016/j.ajog.2014.07.023.
  15. Prasannan L, Blitz MJ, Rochelson BL, et al. Contraindications to Magnesium Sulfate and alternative seizure prophylaxis for severe preeclampsia [09L]. Obstet Gynecol 2020;135:126S. DOI: 10.1097/01.AOG.0000664588.58874.5a.
  16. Satia M, Shilotri M. A study of the obstetric and perinatal outcomes of eclampsia and the use of levetiracetam in its management. Int J Reprod Contracept Obstet Gynecol 2016;5(12):4266–4270. DOI: 10.18203/2320-1770.ijrcog20164325.
  17. Abraham C, Kusheleva N. Management of pre-eclampsia and eclampsia: a simulation. MedEdPORTAL 2019;15:10832. DOI: 10.15766/mep_2374-8265.10832.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.