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

Complications; Cesarean Section Clinical Trial

— CARBETOCIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221531
• Other study ID #: 2014-088
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2014
• Last updated: January 8, 2018
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Reaction
• Complications; Cesarean Section

Intervention

Drug:
• Carbetocin Short-infusion
Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)
• Carbetocin Bolus application
Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Obstetric Anaesthetists' Association United Kingdom

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal uterine tone	Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100	within the first 5 minutes after cord clamping
Secondary	Mean arterial pressure	mean arterial pressure is measured by a non-invasive blood pressure cuff at the upper arm	within first five minutes after cord clamping