Purpose The primary objective of our study was to determine the minimum intravenous dose of carbetocin required to produce adequate uterine contraction in 95% of women (effective dose [ED] 95 ) undergoing elective Cesarean delivery (CD). Methods Eighty term pregnant women with low risk for postpartum hemorrhage (PPH) undergoing elective CD under spinal anesthesia were randomly allocated to receive carbetocin intravenously in doses of 80 lg, 90 lg, 100 lg, 110 lg, or 120 lg upon delivery. The consultant obstetrician evaluated the efficacy of the patient's uterine tone as satisfactory or unsatisfactory. In case of unsatisfactory uterine tone, additional uterotonics were administered as per routine institutional practice. Side effects were monitored during the study period. The main outcome measure was satisfactory uterine tone at two minutes after carbetocin administration. Results Satisfactory uterine tone was obtained in 70 subjects (87%) within the dose range of 80-120 lg of carbetocin. It was not possible to calculate the ED 95 of carbetocin due to the even distribution of women with satisfactory uterine tone across all dose groups (P = 0.99). Similarly, the side effects were similar across all dose groups. There was a high overall incidence of hypotension (55%) following the administration of carbetocin.Conclusions In women at low risk for PPH undergoing elective CD, carbetocin doses of 80-120 lg are similarly effective. There is a high incidence of hypotension associated with carbetocin in these doses, and further studies with doses lower than 80 lg are warranted to assess the balance of efficacy and side effects. This trial was registered at www.clinicaltrials.gov (NCT01262742).
RésuméObjectif L'objectif principal de notre e´tude e´tait de de´terminer la dose intraveineuse minimum de carbe´tocine ne´cessaire pour obtenir une contraction ute´rine approprie´e chez 95 % des femmes (dose efficace [DE] 95 ) subissant une ce´sarienne programme´e. Méthodes Quatre-vingts femmes enceintes a`terme ayant un faible risque d'he´morragie du postpartum subissant une ce´sarienne programme´e sous rachianesthe´sie ont e´teŕ andomise´es pour recevoir des doses intraveineuses de 80 lg, 90 lg, 100 lg, 110 lg ou 120 lg de carbe´tocine au moment de l'accouchement. L'obste´tricien a e´valueĺ 'efficacite´du tonus ute´rin de la patiente comme satisfaisant ou non satisfaisant. En cas de tonus ute´rin non satisfaisant, des me´dicaments ute´rotoniques supple´mentaires ont e´teá dministre´s conforme´ment aux pratiques habituelles de l'e´tablissement. Les effets inde´sirables ont e´te´surveille´s pendant la dure´e de l'e´tude. Le crite`re de jugement principal a éte´un tonus ute´rin satisfaisant deux minutes apre`s l'administration de carbe´tocine.