Magnesium Sulphate for 12 or 24 hours after delivery among women in postpartum period due to preeclampsia: a randomized controled trial

• Grant number: 24/13284-1
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: September 01, 2024
• End date: August 31, 2025
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: José Paulo de Siqueira Guida
• Grantee: Patrícia Guimarães Custódio
• Host Institution: Faculdade de Ciências Médicas (FCM). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

Introduction: Preeclampsia is one of the main causes of maternal death and prematurity in Brazil and worldwide. It is diagnosed when there is hypertension and target organ damage, and its definitive treatment is delivery. Eclampsia is its main complication, and its treatment and prevention can be achieved with the use of magnesium sulfate (MgSO4), whose standard treatment lasts for at least 24 hours. However, international recommendations suggest that shorter intervals or lower doses should be studied for efficacy and effectiveness, as a way to expand its use in low-income countries, where the costs associated with treatment are a major barrier to access. Objective: to compare the use of magnesium sulfate for 24 hours (standard regimen) with 12 hours (alternative regimen) in postpartum women with preeclampsia with signs of severity. Method: This is a randomized, non-blind, non-inferiority clinical study that included postpartum women with indication for magnesium sulfate use due to pregnancy resolution due to preeclampsia with signs of severity admitted to a Brazilian referral hospital. Women will be randomized to use magnesium sulfate for 24 hours (standard regimen) compared with use for 12 hours (alternative regimen). The main outcome assessed will be the need for new sulfation, and secondary outcomes will be length of hospital stay, occurrence of eclampsia, occurrence of renal failure, occurrence of magnesium sulfate poisoning, serum magnesium dosage, and evaluation of the women's experience with the different regimens used.