Haemodynamic Effects of Oxytocin and Carbetocin

Medical University of Graz

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01277978

CARBOXY-005498-78-Graz

2007-005498-78 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

Carbetocin

Description:

Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 100 ug Carbetocin (the clinical standard dose) following delivery of the baby.

Oxytocin

Description:

Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 5 IU oxytocin (the clinical standard dose) following delivery of the baby.