Haemodynamic Effects of Oxytocin and Carbetocin

Completed

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

• Registration Number: NCT01277978
• Lead Sponsor: Medical University of Graz

Brief 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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Healthy pregnant women undergoing elective caesarean section with regional anesthesia

Exclusion Criteria

---Women with

• placenta praevia
• placental abruption
• multiple gestation
• pregnancy related complications and disorders (i.e. preeclampsia, gestational diabetes)
• pre-existing diseases (e.g. insulin-dependent diabetes, cardiovascular or renal diseases, thyroid disease
• taking medication with known impact on the cardiovascular system
• undergoing caesarean section with general anesthesia
• secondary caesarean section

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immediate hemodynamic effects of carbetocin and oxytocin	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	2 day	Number of participants with adverse events as a measure of safety and tolerability
Uterotonic effect	1 day	Impact of both drugs on uterine tone
Estimation of blood loss	2 day	Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).

Trial Locations

Locations (1)

Medical University Graz, Dept. of Obstetrics and Gynecology; 🇦🇹 Graz, Styria, Austria