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Haemodynamic Effects of Oxytocin and Carbetocin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277978
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : January 17, 2011
Information provided by:
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.

Condition or disease
Pregnancy Related Cesarean Section; Complications Adverse Reaction to Oxytocic Agents

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.

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Study Type : Observational
Actual Enrollment : 84 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Oxytocin

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women undergoing elective caesarean section after regional anesthesia at an University hospital providing intrapartum care.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01277978

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Medical University Graz, Dept. of Obstetrics and Gynecology
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Manfred G Mörtl, MD Medical University Graz, Dept. of Obstetrics and Gynecology

Sweeney G, Holbrook AM, Levine M, Yip M, Alfredsson K, Cappi S, et al. Pharmacokinetics of carbetocin, a long-acting oxytocin analogue, in nonpregnant women. Curr Ther Res 1990;47:528-40

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Manfred G. Mörtl, Dr. med., Medical University of Graz, Department of Obstetrics and Gynecology Identifier: NCT01277978    
Other Study ID Numbers: CARBOXY-005498-78-Graz
2007-005498-78 ( EudraCT Number )
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011
Keywords provided by Medical University of Graz:
Caesarean section
Cardiovascular effects
Postpartum hemorrhage
Additional relevant MeSH terms:
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Reproductive Control Agents
Physiological Effects of Drugs