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Carbetocin vs. oxytocin at elective caesarean delivery: a double-blind, randomised, controlled, non-inferiority trial of low- and high-dose regimens.
McDonagh, F; Carvalho, J C A; Abdulla, S; Cordovani, D; Downey, K; Ye, X Y; Farine, D; Morais, M; Balki, M.
Afiliación
  • McDonagh F; Mount Sinai Hospital, University of Toronto, ON, Canada.
  • Carvalho JCA; Mount Sinai Hospital, University of Toronto, ON, Canada.
  • Abdulla S; Department of Anaesthesia and Department of Obstetrics and Gynaecology, University of Toronto, ON, Canada.
  • Cordovani D; Mount Sinai Hospital, University of Toronto, ON, Canada.
  • Downey K; Department of Anaesthesia, McMaster University, Hamilton, ON, Canada.
  • Ye XY; Mount Sinai Hospital, University of Toronto, ON, Canada.
  • Farine D; Maternal and Infant Care Research Center, Mount Sinai Hospital, University of Toronto, ON, Canada.
  • Morais M; Mount Sinai Hospital, University of Toronto, ON, Canada.
  • Balki M; Department of Obstetrics and Gynaecology, University of Toronto, ON, Canada.
Anaesthesia ; 77(8): 892-900, 2022 08.
Article en En | MEDLINE | ID: mdl-35343585
Carbetocin or oxytocin are given routinely as first-line uterotonic drugs following delivery of the neonate during caesarean delivery to prevent postpartum haemorrhage. Low doses may be as effective as high doses with a potential reduction in adverse effects. In this double-blind, randomised, controlled, non-inferiority trial, we assigned low-risk patients undergoing elective caesarean delivery under spinal anaesthesia to one of four groups: carbetocin 20 µg; carbetocin 100 µg; oxytocin 0.5 IU bolus + infusion; and oxytocin 5 IU bolus + infusion. The study drug was given intravenously after delivery of the neonate. Uterine tone was assessed by the obstetrician 2, 5 and 10 minutes after study drug administration according to an 11-point verbal numerical rating scale (0 = atonic, 10 = excellent tone). The primary outcome measure was uterine tone 2 min after study drug administration. The pre-specified non-inferiority margin was 1.2 points on the 11-point scale. Secondary outcomes included uterine tone after 5 and 10 minutes, use of additional uterotonics, blood loss and adverse effects. Data were available for 277 patients. Carbetocin 20 µg resulting in uterine tone of (median (IQR [range])) 8 (7-8 [1-10]) was non-inferior to carbetocin 100 µg with tone 8 (7-9 [3-10]), median (95%CI) difference 0 (-0.44-0.44). Similarly, oxytocin 0.5 IU with tone 7 (6-8 [3-10]) was non-inferior to oxytocin 5 IU with tone 8 (6-8 [2-10]), median (95%CI) difference 1 (0.11-1.89). Carbetocin 20 µg was also non-inferior to oxytocin 5 IU, and oxytocin 0.5 IU was non-inferior to carbetocin 100 µg. Uterine tone after 5 and 10 minutes, use of additional uterotonics, blood loss and adverse effects were similar in all groups.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oxitócicos / Oxitocina / Cesárea / Hemorragia Posparto Tipo de estudio: Clinical_trials / Etiology_studies Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: Anaesthesia Año: 2022 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oxitócicos / Oxitocina / Cesárea / Hemorragia Posparto Tipo de estudio: Clinical_trials / Etiology_studies Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: Anaesthesia Año: 2022 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido