Federal Medical Centre, Abeokuta, Ogun State, Nigeria; Babcock University Teaching Hospital/Babcock University, Ilishan-Remo Ogun Sate, Nigeria.
Federal Medical Centre, Abeokuta, Ogun State, Nigeria.
Pregnancy Hypertens. 2023 Jun;32:22-27. doi: 10.1016/j.preghy.2023.03.001. Epub 2023 Mar 12.
Hypertensive disorders in pregnancy (HDP) are leading causes of maternal mortality (with severe pre-eclampsia/eclampsia [SPE/EC] being causes of death). Magnesium sulphate (MgSO) has proven to be the drug of choice for SPE/EC management. However, its availability and cost remain a drawback to its use in developing countries. This study aimed to compare Zuspan regimen with its 12-hour modification for SPE/EC management in two major hospitals in Abeokuta, Ogun state, South Western Nigeria.
A randomized controlled trial of non-inferior parallel design carried out at Federal Medical Centre and Sacred Heart Hospital, Abeokuta involving 148 consenting women who were randomized into two groups A and B. Both groups had 4 g loading dose of MgSO4, but the duration of maintenance was reduced to 12-hours in Group A (intervention) while Group B received the standard Zuspan regimen (control). Outcome measures were the occurrence/recurrence of convulsions (primary), maternal side effects and perinatal outcomes (secondary).
There was no statistically significant difference in the occurrence/recurrence of seizures between the two groups for both SPE/EC. No signs of maternal toxicity were observed in both arm of the study. There were no statistically significant differences in the perinatal/neonatal death and Apgar scores at 1 and 5 min. However, there was a significant increase in the number of days on admission in the control group of those neonates delivered to mothers with eclampsia.
A 12-hr modification of Zuspan regimen was found to be non-inferior to the standard Zuspan regimen in the management of SPE/EC.
妊娠高血压疾病（HDP）是孕产妇死亡的主要原因（严重子痫/子痫[SPE/EC]是死亡原因）。硫酸镁（MgSO）已被证明是治疗 SPE/EC 的首选药物。然而，其可用性和成本仍然是发展中国家使用它的一个障碍。本研究旨在比较 Zuspan 方案及其 12 小时修改版在尼日利亚西南部奥贡州阿贝奥库塔的两家主要医院治疗 SPE/EC 的效果。
这是一项在联邦医疗中心和圣心医院进行的非劣效性平行设计的随机对照试验，涉及 148 名同意参加的妇女，她们被随机分为两组 A 和 B。两组均给予 4 g 的硫酸镁负荷剂量，但在 A 组（干预组）中维持时间缩短至 12 小时，而 B 组则接受标准的 Zuspan 方案（对照组）。主要结局是抽搐的发生/复发（主要）、母亲的不良反应和围产儿结局（次要）。
两组在 SPE/EC 中均未出现统计学上显著差异。在研究的两个组中都没有观察到母体毒性的迹象。两组的围产儿/新生儿死亡率和 1 分钟和 5 分钟的 Apgar 评分均无统计学差异。然而，在子痫产妇分娩的新生儿中，对照组的住院天数显著增加。
12 小时修改版的 Zuspan 方案在治疗 SPE/EC 方面与标准 Zuspan 方案无差异。
