Pritchard’s Regimen: The Effect of 12-Hour Versus 24-Hour Magnesium Sulphate Maintenance Regimen on the Occurrence of Seizures and Maternal Outcome in Women with Severe Features of Preeclampsia: A Triple-Blind Randomized Controlled Trial
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Keywords
Efficacy, Magnesium Sulphate, Preeclampsia with Severe Features, Randomized Controlled Trial, Seizures, Therapeutic Index
Abstract
Background: Magnesium sulphate (MgSO4) administered for twenty-four hours is the drug of choice for seizure prophylaxis in patients with preeclampsia with severe features. Due to its narrow therapeutic index, a reduction in the duration of MgSO4 administered in the postpartum period may not only prevent the occurrence of seizures but also reduce the adverse effects associated with this drug.This study aim was to compare the efficacy of the 12-hour and 24-hour Pritchard’s MgSO4 maintenance regimen on the occurrence of seizures and maternal outcomes in patients with preeclampsia with severe features.
Methodology: A triple-blind randomized controlled trial was conducted among women with preeclampsia with severe features between 1st June 2022 and January 31st, 2023. The primary outcome measure was the occurrence of seizure in either arm of the study. One hundred and forty-six women were randomized into two groups, those who received a 12-hour MgSO4 regimen and placebo for the remaining twelve hours (Group I) and those who received a 24-hour MgSO4 regimen in the postpartum period (Group II). The collected data was coded and analyzed using Statistical Product and Service Solutions (SPSS) version 26 and p<0.05 was considered significant.
Results: There was no statistically significant difference between the two groups concerning the occurrence of seizures, the need to recommence MgSO4, clinical evidence of toxicity and adverse effects of MgSO4. There was also no statistically significant difference between the two groups in the total dose of MgSO4 administered, duration of urethral catheterization and duration of hospital admission. No maternal mortality was recorded in this study.
Conclusion: The results of this study suggest that the 12-hour MgSO4 maintenance regimen is as efficacious as the traditional 24-hour regimen in preventing seizures without worsening maternal outcomes.
References
2. American College of Obstetricians and Gynaecologists (ACOG) Practice Bulletin No. 222: Gestational Hypertension and Preeclampsia. Obstet Gynecol 2020;135: e237
3. Magee LA, Brown MA, Hall DR, Gupte S, Hennessy A, Karumanchi SA et al. The 2021 International Society for the study of Hypertension in Pregnancy Classification, diagnosis and management recommendations for International Practice. Pregnancy Hypertens 2022;27148
4. Ebeigbe PN, Aziken ME. Early onset pregnancy-induced hypertension/eclampsia in Benin City, Nigeria. Niger J Clin Pract 2010;13(4):388-93.
5. Waugh JS, Smith MC. Hypertensive disorders. In: Edmonds DK, editor. Dewhurst’s Textbook of Obstetrics and Gynaecology 9th Ed. West Sussex UK: John Wiley and Sons, Ltd; 2018:73-84.
6. Dasgupta S, Sarkhel A, Jain A. Single loading dose of magnesium sulphate in severe preeclampsia and eclampsia - Is it effective? A randomized prospective study. Obstet Gynaecol Int J 2015;2(6):189-194.
7. Ekele BA, Muhammed D, Bello LN, Namadina IM. Magnesium sulphate therapy in eclampsia: The Sokoto (ultrashort) regimen. BMC Research Notes 2009; 2:165-168.
8. Kashanian M, Koshpayehzadeh J, Sheikhansan N, Bararpour F, Sahraian G, et al. A comparison between the two methods of magnesium sulphate administration for the duration of 12 versus 24 hours after delivery in patients with severe preeclampsia: A randomized clinical trial; J Mtern Fetal Neonatal Med 2016;29(14):2282-7.
9. Orisabinone IB, Onwudiegwu U, Adeyemi AB, Orji CP, Makinde OI. Shortened versus standard post-partum maintenance therapy of magnesium sulphate in severe preeclampsia: a randomized control trial. Int J Reprod Contracept Obstet Gynecol 2020;9(4):1646-1653.
10. Maia SB, Katz L, Neto CN, Caiadr BV, Azevedo AP, Amorim MM et al. Abbreviated (12-hour) versus traditional (24-hour) post-partum magnesium sulphate therapy in severe preeclampsia. Int J Gynaecol Obstet 2014;126:260-4.
11. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. BMC Med. 2010;8:18.
12. Sathain B, Sreedharan J, Baboo NS, Sharan K, Abhilash ES, Rajesh E. Relevance of sample size determination in medical research. Nepal J Epidem 2010;1(1):4-10.
13. Kabisch M, Ruckes C, Seibert-Grafe M, Blettner M. Randomized controlled trials. Part 17 of a Series on Evaluation of Scientific Publications. Dtsch Arztebl Int 2011;108(39):663-8.
14. Monaghan TF, Agudelo CW, Rahman SN, Wein AJ, Lazar JM, Everaert K, Dmochowski RR. Blinding in clinical trials: seeing the big picture. Medicina 2021;57(7):64.https://doi:10.3390/medicina57070647
15. Unwaha EA, Bello OO, Bello FA, Oladokun A. Intravenous magnesium sulphate in the management of severe preeclampsia: A randomized study of 12-hour versus 24-hour maintenance dose. Int J Gynecol Obstet 2020; 149:37-42.
16. Dixit P, Thakur S, Singh K, Sharma J, Singh S. To compare abbreviated regimens of single dose and 12-hours magnesium sulphate administration with the conventional 24-hours post-partum in severe eclampsia: A randomized clinical trial. International Journal of Clinical Obstetrics and Gynaecology 2020;4(4):205-210.
17. Anjum S, Goel N, Sharma R, Mohsin Z, Garg N. Maternal outcomes after 12 hours and 24 hours of magnesium sulphate therapy for eclampsia. International Journal of Gynaecology and Obstetrics 2016; 132:68-71.
18. Elkhayat W, Atef A, Abdelatly S, El-semary A. A novel protocol for post-partum magnesium sulphate in severe preeclampsia: A randomized controlled trial. The Journal of Maternal-Fetal and Neonatal Medicine 2014:1-5.https://doi:10.3109/14767058.2014.991915.
19. Darngawn L, Jose R, Regi A, Bansal R, Jeyaseelan L. A shortened post-partum magnesium sulphate prophylaxis regimen in preeclamptic women at low risk of eclampsia. International Journal of Gynaecology and Obstetrics 2012;116(3):237-239.
20. The eclampsia trial collaborative group. Which anticonvulsant for women with eclampsia? Evidence from the collaborative eclampsia trial. Lancet 1995;345(8963):1455-63.
21. The Magpie Trial Collaborative Group. Do women with preeclampsia and their babies benefit from magnesium sulphate? The Magpie Trial, a randomized placebo-controlled trial. Lancet 2002;359(9321):1877-1890.
22. Rimal SP, Rijal P, Bhatt R, Thapa K. Loading dose only versus standard dose magnesium sulphate seizure prophylaxis in severe preeclamsia. J Nepal Med Assoc 2017;56(208):388-94.
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