drugset / Trial / NCT01651130

Carbetocin at Elective Cesarean Delivery Part 3

NCT01651130

Non-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 study to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing elective Cesarean delivery.

Timeline

Start
2012-06
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbetocin Peptide 2 ug Intravenous
Comparator Carbetocin Peptide 5 ug Intravenous
Comparator Carbetocin Peptide 10 ug Intravenous
Comparator Carbetocin Peptide 15 ug Intravenous
Comparator Carbetocin Peptide 20 ug Intravenous
Comparator Carbetocin Peptide 100 ug Intravenous

Indications

No indication recorded.