NCT01428817

Carbetocin at Elective Cesarean Delivery Part 2

Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery. Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied. The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Carbetocin	20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
DRUG	Carbetocin	40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
DRUG	Carbetocin	60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
DRUG	Carbetocin	80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
DRUG	Carbetocin	100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-09-05
• Last updated: 2012-03-26

Locations

1 site across 1 country: Canada