drugset / Trial / NCT01428817

Carbetocin at Elective Cesarean Delivery Part 2

NCT01428817

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common 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. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.

Timeline

Start
2011-06
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbetocin Peptide 20 ug Intravenous
Comparator Carbetocin Peptide 40 ug Intravenous
Comparator Carbetocin Peptide 60 ug Intravenous
Comparator Carbetocin Peptide 80 ug Intravenous
Comparator Carbetocin Peptide 100 ug Intravenous

Indications

No indication recorded.