Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Immediate hemodynamic effects of carbetocin and oxytocin
研究概览
简要总结
The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.
详细描述
As there is a trend toward childbearing in later life, pre-existing maternal cardiovascular problems may become more frequent during pregnancy and at delivery. In addition the increasing number of women with congenital or acquired cardiac diseases may not tolerate the induced haemodynamic changes as well as healthy patients. Therefore uterotonic drugs must be safe for the cardiovascular system.
Currently oxytocin is used as a common uterotonic agent in obstetrics. The use of this drug in uterotonic reasons can cause serious haemodynamic side effects which has been shown by several investigators.
Preliminary clinical observations of maternal heart rate and blood pressure suggest that that the use of carbetocin causes less hemodynamic changes than oxytocin.
Primary objective(s):
To evaluate the effect of carbetocin on maternal hemodynamic parameters (heart rate, blood pressure, systemic vascular resistance, cardiac output, stroke volume, heart rate variability, and blood pressure variability) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant women undergoing elective caesarean section with regional anesthesia
排除标准
- •--Women with
- •placenta praevia
- •placental abruption
- •multiple gestation
- •pregnancy related complications and disorders (i.e. preeclampsia, gestational diabetes)
- •pre-existing diseases (e.g. insulin-dependent diabetes, cardiovascular or renal diseases, thyroid disease
- •taking medication with known impact on the cardiovascular system
- •undergoing caesarean section with general anesthesia
- •secondary caesarean section
结局指标
主要结局
Immediate hemodynamic effects of carbetocin and oxytocin
时间窗: 1 day
Maternal heart rate, blood pressure, stroke volume, cardiac output, and systemic vascular resistance will be measured non-invasively. Measurements will be performed starting immediately following administration of the study medication.
次要结局
- Adverse effects(2 day)
- Uterotonic effect(1 day)
- Estimation of blood loss(2 day)