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Completed

NCT Number: NCT01277978

Haemodynamic Effects of Oxytocin and Carbetocin

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Immediate hemodynamic effects of carbetocin and oxytocin

    Time frame: 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 outcomes

  1. Adverse effects

    Time frame: 2 day

    Number of participants with adverse events as a measure of safety and tolerability

  2. Uterotonic effect

    Time frame: 1 day

    Impact of both drugs on uterine tone

  3. Estimation of blood loss

    Time frame: 2 day

    Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 17, 2011
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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