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临床试验/NCT01530230
NCT01530230已完成不适用

Randomised Study on Cardiac Effects of Oxytocin During Caesarean Section in Preeclamptic Women

Uppsala University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2005年11月最近更新:
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
25
试验地点
1
主要终点
Depression of the ST segment on electrocardiograms

研究概览

简要总结

The investigators examined whether there was a difference in the occurrence of ST depressions after injection of five or ten units of oxytocin, in preeclamptic patients delivered by caesarean section (CS) under regional anesthesia.

详细描述

ST depression on electrocardiograms has been reported in healthy women undergoing cesarean section in regional anesthesia. The investigators examined whether there was a difference in the occurrence of electrocardiogram changes suggestive of myocardial ischemia (ST depressions) in preeclamptic patients randomized to five or ten units of oxytocin during cesarean section with regional anesthesia.

In a double-blind randomized controlled study preeclamptic patients undergoing cesarean section under spinal anesthesia were randomized to 5 or 10 units of oxytocin, given as an intravenous bolus. A Holter monitor was used to record electrocardiograms. Non-invasive blood pressure and heart rate were monitored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with preeclampsia undergoing CS under spinal anesthesia. Preeclampsia was diagnosed if blood pressure was ≥ 140/90 mm Hg and if proteinuria of more than 1000 mg/day persisted.

排除标准

  • multiple birth,
  • obesity (body mass index > 35),
  • age < 18 years,
  • complications of the pregnancy other than preeclampsia or non-proficiency in the Swedish language

研究组 & 干预措施

Oxytocin 5 units

Other

干预措施: oxytocin (Drug)

Oxytocin 10 units

Other

干预措施: oxytocin (Drug)

结局指标

主要结局

Depression of the ST segment on electrocardiograms

时间窗: From start of caesarean section until 20 minutes after delivery

次要结局

  • Mean arterial pressure and heart rate.(From start of caesarean section until 20 minutes after delivery)

研究者

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

Maria Jonsson

Principal investigator

Uppsala University Hospital

研究点 (1)

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