Haemodynamic Effects of Oxytocin and Carbetocin

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277978
• Other study ID #: CARBOXY-005498-78-Graz
• Secondary ID: 2007-005498-78
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: January 14, 2011
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: January 2011
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adverse Reaction to Oxytocic Agents
• Cesarean Section; Complications
• Pregnancy Related

Locations

Country	Name	City	State
Austria	Medical University Graz, Dept. of Obstetrics and Gynecology	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Su LL, Chong YS, Samuel M. Oxytocin agonists for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005457. Review. Update in: Cochrane Database Syst Rev. 2012;2:CD005457. — View Citation

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. — View Citation

Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Oct 30;10:CD001808. doi: 10.1002/14651858.CD001808.pub2. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate hemodynamic effects of carbetocin and oxytocin	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.	1 day	No
Secondary	Adverse effects	Number of participants with adverse events as a measure of safety and tolerability	2 day	No
Secondary	Uterotonic effect	Impact of both drugs on uterine tone	1 day	No
Secondary	Estimation of blood loss	Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).	2 day	No