Clinical trial NCT01277978: Haemodynamic Effects of Oxytocin and Carbetocin
Official title: Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Cesarean Section; Complications
Adverse Reaction to Oxytocic Agents
Keywords: Caesarean section
Cardiovascular effects
Postpartum hemorrhage
Carbetocin
Oxytocin
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing elective caesarean section after regional anesthesia at an University hospital providing intrapartum care.

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.

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 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

Primary outcomes:
measure: Immediate hemodynamic effects of carbetocin and oxytocin
timeFrame: 1 day
Secondary outcomes:
measure: Adverse effects
timeFrame: 2 day
measure: Uterotonic effect
timeFrame: 1 day
measure: Estimation of blood loss
timeFrame: 2 day
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Dept. of Obstetrics and Gynecology
state: Styria
Study officials:
affiliation: Medical University Graz, Dept. of Obstetrics and Gynecology
name: Manfred G Mörtl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1054/ijoa.2002.0970.
citation: Su LL, Chong YS, Samuel M. Oxytocin agonists for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD005457. doi: 10.1002/14651858.CD005457.pub2.
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. doi: 10.1097/00001703-200404000-00008.
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.
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
citation: 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. doi: 10.1093/bja/ael302. Epub 2006 Dec 2.
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.
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. doi: 10.1016/s0002-9378(99)70271-1.
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. doi: 10.1016/s1701-2163(16)30659-4.
citation: 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. doi: 10.1530/acta.0.1150155.
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. doi: 10.1038/clpt.1992.103.
citation: 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. doi: 10.1111/j.1471-0528.2011.03022.x. Epub 2011 Jun 14.