CARBETOCIN: Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02221531

Collaborator

Obstetric Anaesthetists' Association United Kingdom (Other)

140

Enrollment

Location

Arms

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.

A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).

Condition or Disease	Intervention/Treatment	Phase
Complications; Cesarean Section Anesthesia; Reaction	Drug: Carbetocin Short-infusion Drug: Carbetocin Bolus application	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Short infusion Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute	Drug: Carbetocin Short-infusion Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)
Other: Bolus application Carbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds	Drug: Carbetocin Bolus application Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds

Arm

Intervention/Treatment

Experimental: Short infusion

Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute

Drug: Carbetocin Short-infusion

Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)

Other: Bolus application

Carbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds

Drug: Carbetocin Bolus application

Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds

Outcome Measures

Primary Outcome Measures

Maximal uterine tone [within the first 5 minutes after cord clamping]
Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100

Secondary Outcome Measures

Mean arterial pressure [within first five minutes after cord clamping]
mean arterial pressure is measured by a non-invasive blood pressure cuff at the upper arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 46 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

healthy women
singleton pregnancy
caesarean section under regional anaesthesia
older than 18 years
written informed consent

Exclusion Criteria:

emergency caesarean section
secondary caesarean section due to fetal distress
comorbidities (cardiovascular, kidney or liver disorder, epilepsy)
obstetric diseases (hypertension, (pre-)eclampsia)
uterine malformation (including uterine fibroids)
bleeding disorder
known hypersensitivity to carbetocin or oxytocin
fetal malformation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland
Obstetric Anaesthetists' Association United Kingdom

Investigators

Principal Investigator: Salome Dell-Kuster, MD, Department of Anaesthesiology, University Hospital Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT02221531

Other Study ID Numbers:

2014-088

First Posted:

Aug 20, 2014

Last Update Posted:

Jan 9, 2018

Last Verified:

Jan 1, 2018

Additional relevant MeSH terms:

Carbetocin

Oxytocin

Study Results

No Results Posted as of Jan 9, 2018