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临床试验/NCT06791668
NCT06791668招募中不适用

Comparison of Different Regimens of Magnesium Sulphate in Patients with Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Occurrence of eclamptic fits

研究概览

简要总结

The goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). The medication (magnesium sulphate) helps to prevent seizures. The main question this study aims to answer is:

What are the different regimens of magnesium sulphate that are used to prevent seizures in pregnant women with severe pre-eclampsia?

Participants already have taken the magnesium sulphate as part of their regular medical care for severe pre-eclampsia. Researchers will look into the records of the participants in the past 5 years to collect the data.

详细描述

This will be a retrospective study describing the different regimens of MgSO4 used in patients diagnosed with SPE in Ain Shams University Maternity Hospital (ASUMH), and the occurrence of eclamptic fits and any other complications with each of them.

Methodology:

  1. Protocol approval will be sought from ethical committee and hospital administration.
  2. Screening of all hospital records over the past 5 years to identify eligible records.
  3. Eligible records will be reviewed to extract the following data:

Age, Parity, Gestational age, BMI, Prior medical disorders, previous surgeries - including cesarean section (CS).

Data upon admission: (Blood pressure, albuminuria) Available labs (CBC, AST, ALT, serum creatinine, PTT, INR) Timing (since admission) and route of delivery. Regimen of MgSO4 used (loading and maintenance doses, the route, and total time of therapy - antepartum and postpartum); any changes in dosage, and the reason for change.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •All hospital records of patients diagnosed as preeclampsia with severe features planned to receive magnesium sulphate.

排除标准

  • •Records with missing data about the regimen of magnesium sulphate used

结局指标

主要结局

Occurrence of eclamptic fits

时间窗: within 24 hours before or after delivery

Development of generalized tonic clonic convulsions in pregnant women with preeclampsia

次要结局

  • magnesium sulphate toxicity(within 48 hours before or after delivery)
  • primary postpartum hemorrhage(within 24 hours after delivery)
  • ICU admission(within 48 hours before or after delivery)

研究者

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

Rania Hassan Mostafa

Dr

Ain Shams University

研究点 (1)

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