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Carbetocin at elective cesarean delivery: a randomized controlled trial to determine the effective dose, part 3-final
Abstract Number: GM 3
Abstract Type: Original Research
Introduction: Carbetocin has been recommended as the preferred uterotonic at elective cesarean delivery (CD) by the Society of Obstetricians and Gynecologists of Canada since 2009 (1).Its main advantage is a longer half-life compared to that of oxytocin (40 min vs. 4-10 min) (2). A systematic review comparing carbetocin 100 mcg with variable doses of oxytocin at CD showed a reduction in the need for additional uterotonics with carbetocin, but no difference in the incidence of postpartum hemorrhage or side effects (3). Two previous dose-finding studies of carbetocin at elective CD, with doses varying from 20 to 120mcg, have shown similar efficacy across all doses (4,5). We aimed to determine the minimum effective dose of carbetocin (ED90) at elective CD.
Methods: We conducted a randomized, double-blind, dose-finding study of carbetocin. Inclusion criteria were ASA I/II women undergoing elective CD under spinal anesthesia. Carbetocin was administered intravenously over 1 minute upon delivery of the fetus. The obstetrician assessed the uterine tone at one-minute interval for 5 minutes and then at his/her discretion until the end of surgery and decided on the need for additional uterotonic. The dose of carbetocin for each patient was determined according to a biased coin up-and-down sequential allocation scheme designed to cluster doses close to ED90. The initial dose was 10 mcg, with increments/decrements of 5 mcg. The anesthesiologist, obstetrician and patient were blinded to the study dose. The primary outcome was the need for additional uterotonic intraoperatively, in which case the treatment was considered a failure. Secondary outcomes included use of additional uterotonic agents within 24 hours of the completion of surgery, estimated blood loss and side effects. Data analysis was done by the Dixon-Mood method for non-parametric data.
Results: Forty patients were recruited. The ED90 of carbetocin was calculated as 14.8 mcg (95% CI 13.7-15.8mcg). Thirty-seven patients did not require additional intraoperative uterotonics. Of the three patients that required additional uterotonic, one had received 15 mcg and two had received 10 mcg of carbetocin. Overall estimated blood loss using a hematocrit variation method was 785.6±402.8 ml. The overall incidence of hypotension was 37.5%.
Discussion: Our study shows that at elective CD, the ED90 of carbetocin is about 15mcg, which is less than one fifth of the currently recommended dose of 100 mcg. The lower incidence of hypotension in our study, as compared to 45-55% previously reported in other studies (4,5) may represent an advantage, however, this trend warrants confirmation in a larger study. Consideration should be given to the use of lower doses of carbetocin at elective CD.
References: 1) J Obstet Gynaecol Can 2009; 31:980-93; 2) Curr Ther Res 1990; 47: 528-540; 3) Cochrane database of systematic reviews 2012; 4:pCD005457; 4) Can J Anesth 2012; 59: 751-757; 5) SOAP 2012, abstract T-7