Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial|
- Utilization of a second uterotonic drug [ Time Frame: First 48 hours of the postpartum ] [ Designated as safety issue: No ]
- Incidence of side effects [ Time Frame: During the fifteen minutes following the administration of carbetocin ] [ Designated as safety issue: No ]
- Incidence of major complications [ Time Frame: First 48 hours of the postpartum ] [ Designated as safety issue: No ]
- Drop in hemoglobin measurement [ Time Frame: on the second post-partum day ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Carbetocin 100 mcg||
Administration of carbetocin 100 mcg , after clamping the umbilical cord
|Experimental: Carbetocin 50 mcg||
Administration of carbetocin 50 mcg , after clamping the umbilical cord
Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.
Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.