Pregnancy Related Clinical Trial
Official title:
Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail
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.
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.
To compare the haemodynamic changes of carbetocin versus oxytocin.
Secondary objective(s) To evaluate the need of additional drugs and methods to control
uterine tone.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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