Pregnancy hypertension · 2025
A 12-hour versus 24-hour magnesium sulfate intravenous regimen in postpartum women with preeclampsia: a randomized clinical trial.
Equivalence TrialСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Alves de Melo Silva Maria Laura, Custódio Patricia Guimarães, Costa Maria Laura, Surita Fernanda de Castro, Guida José Paulo de Siqueira
Аннотация
INTRODUCTION: Magnesium sulfate (MgSO4) is the standard drug for treatment of eclampsia, and to prevent its occurrence in women with preeclampsia with severe features, however, the ideal postpartum treatment duration remains unclear.
OBJECTIVE: To assess whether a 12-hour postpartum MgSO4 regimen is non-inferior to the standard 24-hour regimen.
METHODS: This was a single-center, randomized, non-blinded, non-inferiority clinical trial conducted at a tertiary hospital in Brazil. The intervention involved the use of MgSO4 for 12 h after childbirth, compared to the standard regimen of 24 h. Women were randomly assigned to each group. The primary outcome was a new use of MgSO4 due to recurrence of symptoms within the first 10 days of childbirth. Secondary outcomes included maternal complications, pregnancy outcomes, and neonatal outcomes.
RESULTS: 79 women were included in this study (40 in the 12-hour group and 39 in the 24-hour group). The demographic characteristics of women in both groups were similar. The rate of use of MgSO4 in the postpartum was similar in both groups (4 vs 9, 10.0 % vs 23.1 %, p = 0.206). After enrolment, no cases of eclampsia occurred in the 12-hour group, and one occurred in the 24-hour group. No significant differences were found regarding birth weight, Apgar scores, or NICU admissions.
CONCLUSION: A 12-hour magnesium sulfate regimen was non-inferior to the 24-hour standard, supporting its safety and potential utility in optimizing postpartum care, especially in resource-constrained settings.
OBJECTIVE: To assess whether a 12-hour postpartum MgSO4 regimen is non-inferior to the standard 24-hour regimen.
METHODS: This was a single-center, randomized, non-blinded, non-inferiority clinical trial conducted at a tertiary hospital in Brazil. The intervention involved the use of MgSO4 for 12 h after childbirth, compared to the standard regimen of 24 h. Women were randomly assigned to each group. The primary outcome was a new use of MgSO4 due to recurrence of symptoms within the first 10 days of childbirth. Secondary outcomes included maternal complications, pregnancy outcomes, and neonatal outcomes.
RESULTS: 79 women were included in this study (40 in the 12-hour group and 39 in the 24-hour group). The demographic characteristics of women in both groups were similar. The rate of use of MgSO4 in the postpartum was similar in both groups (4 vs 9, 10.0 % vs 23.1 %, p = 0.206). After enrolment, no cases of eclampsia occurred in the 12-hour group, and one occurred in the 24-hour group. No significant differences were found regarding birth weight, Apgar scores, or NICU admissions.
CONCLUSION: A 12-hour magnesium sulfate regimen was non-inferior to the 24-hour standard, supporting its safety and potential utility in optimizing postpartum care, especially in resource-constrained settings.