Carbetocin versus oxytocin for prevention of postpartum hemorrhage after vaginal delivery in high risk women (Publication with Expression of Concern)

Objective: To compare effectiveness and tolerability of carbetocin versus oxytocin in prevention of postpartum hemorrhage (PPH) after vaginal delivery.Methods: A prospective double-blinded randomized study conducted on 200 pregnant women randomized into two groups: Group 1 (100 women) received single 100g IM dose of carbetocin and Group 2 received of 5IU oxytocin IM. Both groups received their drug after fetal and before placental delivery.Results: There was a statistically significant difference between the two study groups regarding amount of bleeding (337.73118.77 versus 378 +/- 143.2), occurrence of PPH (4 versus 16%), need for other uterotonics (23 versus 37%) and hemoglobin difference between before and after delivery (0.55 +/- 0.35 versus 0.96 +/- 0.62) (all being lower in carbetocin group) and measured hemoglobin 24h after delivery (being higher in carbetocin group); however, there was no significant difference between the two study groups regarding occurrence of major PPH and the need for blood transfusion. Women in carbetocin group showed a statistically significant lower systolic and diastolic blood pressure immediately after delivery and at 30 and 60min than women in oxytocin group. There was no significant difference between the two study groups regarding occurrence of nausea, vomiting, flushing, dizziness, headache, shivering, metallic taste, dyspnea, palpitation and itching. Women in carbetocin group experienced tachycardia more than women in oxytocin group.Conclusions: Carbitocin is a better alternative to traditional oxytocin in prevention of PPH after vaginal delivery with minimal hemodynamic changes and similar side effects.