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临床试验/NCT03164304
NCT03164304已完成4 期

Efficacy and Safety of One Gram Versus Two Grams Intravenous Maintenance Dose of Magnesium Sulfate in Women With Severe Pre-eclampsia: a Randomized Clinical Trial.

Assiut University1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2017年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
222
试验地点
1
主要终点
The rate of convulsions in each group.

研究概览

简要总结

Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form), and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)

详细描述

Treatment for patients who have developed preeclampsia or eclampsia mainly consists of control of hypertension, magnesium sulphate for prevention of eclampsia and convulsions, and planning for delivery.

Magnesium sulfate has been used to prevent eclamptic convulsion since 1925, its efficacy was confirmed by a large randomized controlled trial in 2002. Eclampsia could be prevented in more than 50% after magnesium sulfate administration . The World Health Organization recommended magnesium sulfate as the most effective, safe, and low-cost drug for the prevention of seizure in severe preeclampsia and eclampsia . The recommended dose of magnesium sulfate is 4 to 6 gram intravenous loading dose, followed by maintenance intravenous drip at the rate of 1 to 2 gram per hour .

Although different magnesium sulfate regimens have been tested, two dosing regimens are internationally recommended and widely used. The Pritchard regimen is a predominantly intramuscular regimen given as a loading dose of 4 g intravenously , and 5 g Intramuscular into each buttock followed by a maintenance dose of 5 g Intramuscular every 4 hours. This regimen is popular in resource-limited settings where intravenously administration of magnesium sulfate may not be feasible. However, it is associated with pain and a higher risk of infection at the injection site.

The Zuspan regimen is given as a 4 gram intravenously loading dose followed by continuous intravenously infusion of 1 gram per hour.

Either 1 gram or 2 gram maintenance dose of Magnesium Sulphate has been reported to reduce the development of eclampsia. Randomized controlled trials offering direct comparison between these 2 doses are lacking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women admitted to Women health hospital with a diagnosis of severe pre-eclampsia

排除标准

  • 1- Women with Non-proteinuric hypertension, 2- severe renal impairment 3- Myasthenia gravis 4- High amount of magnesium in blood 5- Low or high amount of calcium in blood 6- Myocardial damage, diabetic coma, heart block

研究组 & 干预措施

One gram magnesium sulfate

Active Comparator

Pregnant women with a diagnosis of severe pre-eclampsia will receive 1 g of mgso4 to prevent and control of convulsions

干预措施: Magnesium Sulfate (Drug)

Two grams magnesium sulfate

Experimental

Pregnant women with a diagnosis of severe pre-eclampsia will receive 2 g of mgso4 to prevent and control of convulsions

干预措施: Magnesium Sulfate (Drug)

结局指标

主要结局

The rate of convulsions in each group.

时间窗: 24 hour

the number of participants who have convulsion

The rate of adverse events in each group

时间窗: 24 hour

the number of participants who have adverse events

The percentage of women reaching the Mg therapeutic level of 4,8 mg/dl

时间窗: 24 hour

Follow up by Serum Magnesium level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Abbas

principal investigator

Assiut University

研究点 (1)

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