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.
Study Type
OBSERVATIONAL
Enrollment
84
Medical University Graz, Dept. of Obstetrics and Gynecology
Graz, Styria, Austria
Immediate hemodynamic effects of carbetocin and oxytocin
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: 1 day
Adverse effects
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 2 day
Uterotonic effect
Impact of both drugs on uterine tone
Time frame: 1 day
Estimation of blood loss
Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).
Time frame: 2 day
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