Objectives To evaluate the uterotonic effect of carbetocin compared with oxytocin in emergency cesarean delivery in Iraq. Methods A double-blinded randomized noninferiority single center trial. Three-hundred patients were systematically randomized to intravenous bolus injection of 10 IU oxytocin or 100 mcg carbetocin after delivery in a ratio of 2:1. The primary outcome was additional uterotonic use when inadequate uterine tone occur in the first 24 h after delivery. Secondary outcomes include the need for blood transfusion, blood pressure and pulse rate changes within an hour of drugs administration. Noninferiority margins for the relative risks outcomes was 4%. Results Addition uterotonics use was significantly lower in carbetocin group with a risk ratio of 0.36. Carbetocin was superior to oxytocin in reducing the need for additional uterotonic drugs by 12% and non-inferior to oxytocin for blood transfusion 3.5%. Noninferiority was not shown for the outcome of sever blood loss. Miner changes in blood pressure and pulse rate were observed in carbetocin group compared to oxytocin but clinically were not significant. Conclusions Heat stable carbetocin is effective in reducing additional uterotonics use compared to oxytocin without clinically significant change in blood pressure or pulse rate, therefore, can be a potential alternative in Iraq.

中文翻译：

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热稳定卡贝缩宫素与催产素在紧急剖宫产中预防产后出血的随机对照试验

目的比较卡贝缩宫素与催产素在伊拉克紧急剖宫产中的宫缩效果。方法 一项双盲随机非劣效性单中心试验。300 名患者在分娩后以 2:1 的比例被系统地随机分配至静脉推注 10 IU 催产素或 100 mcg 卡贝缩宫素。主要结果是在分娩后最初 24 小时内出现子宫张力不足时额外使用宫缩剂。次要结果包括在给药后一小时内需要输血、血压和脉搏变化。相对风险结果的非劣效性边缘为 4%。结果 卡贝缩宫素组额外宫缩剂的使用显着降低，风险比为 0.36。卡贝缩宫素在减少对额外子宫收缩药物的需求方面优于催产素 12%，在输血方面不劣于催产素 3.5%。严重失血的结果未显示非劣效性。与催产素相比，卡贝缩宫素组的血压和脉率有更小的变化，但临床上没有显着性差异。结论 与催产素相比，热稳定性卡贝缩宫素可有效减少额外宫缩剂的使用，而血压或脉率没有临床显着变化，因此，在伊拉克可能是一种潜在的替代品。与催产素相比，卡贝缩宫素组在血压和脉搏率方面观察到了较小的变化，但在临床上没有显着性差异。结论 与催产素相比，热稳定性卡贝缩宫素可有效减少额外宫缩剂的使用，而血压或脉率没有临床显着变化，因此，在伊拉克可能是一种潜在的替代方案。与催产素相比，卡贝缩宫素组的血压和脉率有更小的变化，但临床上没有显着性差异。结论 与催产素相比，热稳定性卡贝缩宫素可有效减少额外宫缩剂的使用，而血压或脉率没有临床显着变化，因此，在伊拉克可能是一种潜在的替代品。