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

NCT02221531 | Completed Phase 4 DMC

• 1 other identifier: 2014-088
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean arterial pressure

  within first five minutes after cord clamping

Study Arms (2)

Short infusion

EXPERIMENTAL

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

Drug: Carbetocin Short-infusion

Bolus application

OTHER

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

Drug: Carbetocin Bolus application

Interventions

Carbetocin Short-infusion DRUG

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

Short infusion

Carbetocin Bolus application DRUG

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

Bolus application

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Obstetric Anaesthetists' Association United Kingdom: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 28498927 DERIVED

• 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.

  PMID: 27004531 DERIVED

Study Officials

• Salome Dell-Kuster, MD

  Department of Anaesthesiology, University Hospital Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CH (1)