Medical University Graz, Dept. of Obstetrics and Gynecology
Graz, Styria, 8036, Austria
NCT Number: NCT01277978
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.
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Notify Me18 year–40 year
Female
Observational
Graz, Styria, 8036, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
---Women with
Time frame: 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.
Time frame: 2 day
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 1 day
Impact of both drugs on uterine tone
Time frame: 2 day
Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).
Medical University of Graz
Other
Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail
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