NCT01277978

Haemodynamic Effects of Oxytocin and Carbetocin

Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pregnancy Related
• Cesarean Section; Complications
• Adverse Reaction to Oxytocic Agents

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2011-01-17
• Last updated: 2011-01-17

Locations

1 site across 1 country: Austria