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

NCT ID: NCT02221531

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-11-30

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).

Conditions

Complications; Cesarean Section; Anesthesia; Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Short infusion

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

Group Type: EXPERIMENTAL

Carbetocin Short-infusion

Intervention Type: DRUG

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

Bolus application

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

Group Type: OTHER

Carbetocin Bolus application

Intervention Type: DRUG

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

Interventions

Carbetocin Short-infusion

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

Intervention Type: DRUG

Carbetocin Bolus application

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Obstetric Anaesthetists' Association United Kingdom

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salome Dell-Kuster, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, University Hospital Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Dell-Kuster S, Hoesli I, Lapaire O, Seeberger E, Steiner LA, Bucher HC, Girard T. Efficacy and safety of carbetocin given as an intravenous bolus compared with short infusion for Caesarean section - double-blind, double-dummy, randomized controlled non-inferiority trial. Br J Anaesth. 2017 May 1;118(5):772-780. doi: 10.1093/bja/aex034.

Reference Type: DERIVED

PMID: 28498927 (View on PubMed)

Dell-Kuster S, Hoesli I, Lapaire O, Seeberger E, Steiner LA, Bucher HC, Girard T. Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial. Trials. 2016 Mar 22;17:155. doi: 10.1186/s13063-016-1285-5.

Reference Type: DERIVED

PMID: 27004531 (View on PubMed)

Other Identifiers

2014-088

Identifier Type: -

Identifier Source: org_study_id