A randomized controlled trial on the comparison of two doses of carbetocin with oxytocin for the prevention of postpartum hemorrhage (concert trial).

Abstract

To compare the effectiveness of 50 and 100 μg of carbetocin with 10 IU of oxytocin for the prevention of postpartum hemorrhage (PPH). This was a triple-blind, non-inferiority trial involving pregnant women recruited at term. We compared two doses of carbetocin (50 and 100 μg) with 10 IU of oxytocin administered as uterotonic agent after vaginal or cesarean delivery. Uterine contractility was assessed at 2- and 5-min after uterotonic administration. The association between adequate uterine tone and PPH with the patients' characteristics were examined using the chi-square test. Effect of the drugs on the odds of developing PPH was examined using logistics regressions. All analyses were conducted using STATA (StataCorp L.L.C.) with a significance level set at 0.05. In total, 324 women (50 μg carbetocin group-111, 100 μg carbetocin group-106, and oxytocin group-107) participated in the study. There was a significantly higher proportion of women with adequate uterine tone in those that had 100 μg carbetocin relative to 50 μg and 10 IU oxytocin at 5 min (p < 0.001). Patients who received oxytocin had a higher average blood loss than women that had either 50 or 100 μg carbetocin (p = 0.128). There was a significant difference in the need for additional uterotonic, with a higher proportion of participants among those who received 10 IU of oxytocin (p < 0.001). Patients that had 100 μg of carbetocin had a better adequate uterine tone at the fifth minute compared to those who had 50 μg and 10 IU of oxytocin. Generally, carbetocin use was less likely associated with risk of PPH and use of additional intervention.