Haemodynamic Effects of Oxytocin and Carbetocin - Full Text View

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:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Oxytocin

U.S. FDA Resources

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

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:

Pinder AJ, Dresner M, Calow C, Shorten GD, O'Riordan J, Johnson R. Haemodynamic changes caused by oxytocin during caesarean section under spinal anaesthesia. Int J Obstet Anesth. 2002 Jul;11(3):156-9.

Su LL, Chong YS, Samuel M. Oxytocin agonists for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005457. Review.

Chong YS, Su LL, Arulkumaran S. Current strategies for the prevention of postpartum haemorrhage in the third stage of labour. Curr Opin Obstet Gynecol. 2004 Apr;16(2):143-50. Review.

Elbourne DR, Prendiville WJ, Carroli G, Wood J, McDonald S. Prophylactic use of oxytocin in the third stage of labour. Cochrane Database Syst Rev. 2001;(4):CD001808. Review.

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

Thomas JS, Koh SH, Cooper GM. Haemodynamic effects of oxytocin given as i.v. bolus or infusion on women undergoing Caesarean section. Br J Anaesth. 2007 Jan;98(1):116-9. Epub 2006 Dec 2.

Boucher M, Horbay GL, Griffin P, Deschamps Y, Desjardins C, Schulz M, Wassenaar W. Double-blind, randomized comparison of the effect of carbetocin and oxytocin on intraoperative blood loss and uterine tone of patients undergoing cesarean section. J Perinatol. 1998 May-Jun;18(3):202-7.

Dansereau J, Joshi AK, Helewa ME, Doran TA, Lange IR, Luther ER, Farine D, Schulz ML, Horbay GL, Griffin P, Wassenaar W. Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):670-6.

Boucher M, Nimrod CA, Tawagi GF, Meeker TA, Rennicks White RE, Varin J. Comparison of carbetocin and oxytocin for the prevention of postpartum hemorrhage following vaginal delivery:a double-blind randomized trial. J Obstet Gynaecol Can. 2004 May;26(5):481-8.

Atke A, Vilhardt H. Uterotonic activity and myometrial receptor affinity of 1-deamino-1-carba-2-tyrosine(O-methyl)-oxytocin. Acta Endocrinol (Copenh). 1987 May;115(1):155-60.

Hunter DJ, Schulz P, Wassenaar W. Effect of carbetocin, a long-acting oxytocin analog on the postpartum uterus. Clin Pharmacol Ther. 1992 Jul;52(1):60-7.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moertl MG, Friedrich S, Kraschl J, Wadsack C, Lang U, Schlembach D. Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. BJOG. 2011 Oct;118(11):1349-56. Epub 2011 Jun 14.

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 June 18, 2013