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临床试验/NCT03237000
NCT03237000Unknown4 期

Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Fetal heart rate tracing

研究概览

简要总结

Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and mode of delivery will be labelled on CTG.

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.

Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels

详细描述

Admission CTG:

Admission CTG will be performed for 20 minutes

I-Settings:

  1. Settings on a CTG machine will be standardised to enable a consistent approach of interpretation of traces.
  2. Paper speed of 3cm per minute will be adopted.
  3. CTGs will be labelled with mother's name, hospital number.
  4. Date and time settings on machines will be labelled at commencement of tracing.
  5. Maternal heart rate will be recorded and noted on CTG.
  6. Following birth date, time and mode of delivery will be labelled on CTG.

Magnesium Sulphate hepatahydrate administration:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant Women in the third trimester.
  • Severely preeclamptic patients.
  • Singleton Pregnancy.
  • Patients with normal admission CTG

排除标准

  • Evidence of fetal anomalies on scan.
  • Concomitant maternal morbidities as diabetes, cardiac disease.
  • Patients contraindicated to take MgSo4 e.g.: advanced renal disease.
  • Abnormal admission CTG.
  • Morbid obesity.

研究组 & 干预措施

MgSO4

Experimental

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.

干预措施: MgSO4 (Drug)

结局指标

主要结局

Fetal heart rate tracing

时间窗: 20 minutes after MgSO4 administration

Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted

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 Maged

Professor

Cairo University

研究点 (1)

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