Haemodynamic Effects of Oxytocin and Carbetocin

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01277978
First received: January 13, 2011
Last updated: January 14, 2011
Last verified: January 2011
  Purpose

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
Pregnancy Related
Cesarean Section; Complications
Adverse Reaction to Oxytocic Agents

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Immediate hemodynamic effects of carbetocin and oxytocin [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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:
  • Adverse effects [ Time Frame: 2 day ] [ Designated as safety issue: No ]
    Number of participants with adverse events as a measure of safety and tolerability

  • Uterotonic effect [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Impact of both drugs on uterine tone

  • Estimation of blood loss [ Time Frame: 2 day ] [ Designated as safety issue: No ]
    Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).


Enrollment: 84
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Carbetocin
Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 100 ug Carbetocin (the clinical standard dose) following delivery of the baby.
Oxytocin
Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 5 IU oxytocin (the clinical standard dose) following delivery of the baby.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277978

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

Publications:
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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manfred G. Mörtl, Dr. med., Medical University of Graz, Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT01277978     History of Changes
Other Study ID Numbers: CARBOXY-005498-78-Graz, 2007-005498-78
Study First Received: January 13, 2011
Last Updated: January 14, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Caesarean section
Cardiovascular effects
Postpartum hemorrhage
Carbetocin
Oxytocin

Additional relevant MeSH terms:
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014