跳至主要内容
临床试验/NCT04576364
NCT04576364已完成不适用

12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients :A Randomized Controlled Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
280
试验地点
2
主要终点
Need to prolong treatment

研究概览

简要总结

To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects.

详细描述

Hypertensive disorders of pregnancy constitute one of the leading causes of maternal and perinatal mortality worldwide. It has been estimated that preeclampsia complicates 2-8% of pregnancies globally.

Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term. Although often accompanied by new-onset proteinuria, hypertension and other signs or symptoms of preeclampsia may present in some women in the absence of proteinuria. Recently preeclampsia is divided into preeclampsia with severe features, preeclampsia without severe, features. One of serious complication of preeclampsia is occurrence of eclampsia. Eclampsia refers to the occurrence of new-onset, generalized, tonic-clonic seizures or coma in a woman with preeclampsia. Eclampsia can be prevented with magnesium sulphate, which decreases the risk of seizures by 50%, paralleled by a reduction in maternal mortality. It is considered as the gold standard of management of eclampsia Although magnesium sulphate administration is recommended for all women with severe preeclampsia, consensus has not yet to be reached on the ideal duration of prophylactic postpartum anticonvulsant therapy. The use of magnesium sulphate has been recommended for 24 hours following delivery, the period of greatest risk for the occurrence of eclampsia. There are other regimen 12-hour, 6-hour Use of magnesium sulphate therapy is not without complications, consequently longer duration therapy possesses the risk of magnesium toxicity such as respiratory depression, renal and neuromuscular dysfunction. Risks of these complications require regular supervision; hence it is particularly important to assess the minimum effective duration of treatment

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who have pre-eclampsia with severe features as defined by American College of Obstetricians and Gynecologists guidelines 2019(defined in methodology)
  • Singleton pregnancy.
  • who accept to participate the study.

排除标准

  • Patients with eclampsia
  • Central Nervous System disorder
  • Chronic kidney disease
  • Seizures due to metabolic disturbances, space occupying lesions or intra cerebral infections
  • Cardiac patients
  • Hypersensitivity to Mgso4

研究组 & 干预措施

12-hour postpartum Mgso4

Active Comparator

Patients having preeclampsia with severe features will receive 12-hour postpartum Mgso4

干预措施: Magnesium sulfate for 12 hour (Drug)

24-hour postpartum Mgso4

Active Comparator

Patients having preeclampsia with severe features will receive 24-hour postpartum Mgso4

干预措施: Magnesium sulfate for 24 hour (Drug)

结局指标

主要结局

Need to prolong treatment

时间窗: up to 12 hour

Compare efficacy of 12-hour vs 24 hour postpartum Mgso4 in the term of Percentage of patients who will Need to prolong treatment in each group.

次要结局

  • Percentage of prevention of eclampsia(up to 24 hour)

研究者

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

Mai Mahmoud Mohamed

Principal Investigator

Assiut University

研究点 (2)

Loading locations...

相似试验