Mount Sinai Hospital, University of Toronto, ON, Canada.
Department of Anaesthesia and Department of Obstetrics and Gynaecology, University of Toronto, ON, Canada.
Anaesthesia. 2022 Aug;77(8):892-900. doi: 10.1111/anae.15714. Epub 2022 Mar 28.
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.
缩宫素或卡贝缩宫素通常在新生儿娩出后用于剖宫产以预防产后出血。低剂量可能与高剂量一样有效，且不良反应可能减少。在这项双盲、随机、对照、非劣效性试验中，我们将接受脊髓麻醉下择期剖宫产的低危患者分配至以下四组之一：卡贝缩宫素 20μg；卡贝缩宫素 100μg；缩宫素 0.5IU 推注+输注；缩宫素 5IU 推注+输注。新生儿娩出后静脉给予研究药物。根据 11 点数字评分量表（0=无宫缩，10=宫缩极好），产科医生在给药后 2、5 和 10 分钟评估子宫收缩情况。主要结局测量指标为给药后 2 分钟的子宫收缩情况。预先设定的非劣效性边界为 11 点评分量表上的 1.2 分。次要结局包括给药后 5 分钟和 10 分钟的子宫收缩情况、额外使用宫缩剂、出血量和不良反应。共有 277 名患者的数据可用。卡贝缩宫素 20μg 引起的子宫收缩程度为 8（7-8 [1-10]），与卡贝缩宫素 100μg 引起的 8（7-9 [3-10]）相比无差异，中位数（95%CI）差值为 0（-0.44-0.44）。同样，缩宫素 0.5IU 引起的子宫收缩程度为 7（6-8 [3-10]）与缩宫素 5IU 引起的子宫收缩程度为 8（6-8 [2-10]）相比无差异，中位数（95%CI）差值为 1（0.11-1.89）。卡贝缩宫素 20μg 也与缩宫素 5IU 相比无差异，缩宫素 0.5IU 与卡贝缩宫素 100μg 相比无差异。给药后 5 分钟和 10 分钟的子宫收缩情况、额外使用宫缩剂、出血量和不良反应在所有组中均相似。
