Haemodynamic Effects of Oxytocin and Carbetocin
Cesarean Section; Complications
Adverse Reaction to Oxytocic Agents
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail|
- Immediate hemodynamic effects of carbetocin and oxytocin [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
- Adverse effects [ Time Frame: 2 day ] [ Designated as safety issue: No ]Number of participants with adverse events as a measure of safety and tolerability
- Uterotonic effect [ Time Frame: 1 day ] [ Designated as safety issue: No ]Impact of both drugs on uterine tone
- Estimation of blood loss [ Time Frame: 2 day ] [ Designated as safety issue: No ]Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).
|Study Start Date:||January 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 100 ug Carbetocin (the clinical standard dose) following delivery of the baby.
Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 5 IU oxytocin (the clinical standard dose) following delivery of the baby.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277978
|Medical University Graz, Dept. of Obstetrics and Gynecology|
|Graz, Styria, Austria, 8036|
|Principal Investigator:||Manfred G Mörtl, MD||Medical University Graz, Dept. of Obstetrics and Gynecology|