A Phase 4 interventional study of Carbetocin Short-infusion and Carbetocin Bolus application in Complications; Cesarean Section and Anesthesia; Reaction, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 46 Years. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
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).
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute
Drug: Carbetocin Short-infusion
Carbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds
Drug: Carbetocin Bolus application
Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)
Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds
Maximal uterine tone
Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100
Time frame: within the first 5 minutes after cord clamping
Mean arterial pressure
mean arterial pressure is measured by a non-invasive blood pressure cuff at the upper arm
Time frame: within first five minutes after cord clamping
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland