Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Obstetric Anaesthetists' Association United Kingdom