drugset / Trial / NCT01262742

Carbetocin at Elective Cesarean Delivery

NCT01262742

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.

Timeline

Start
2010-11
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbetocin Peptide 80 ug Intravenous
Comparator Carbetocin Peptide 90 ug Intravenous
Comparator Carbetocin Peptide 100 ug Intravenous
Comparator Carbetocin Peptide 110 ug Intravenous
Comparator Carbetocin Peptide 120 ug Intravenous

Indications

No indication recorded.