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Abstract：
BACKGROUND: The two most commonly used uterotonic drugs in caesarean section are oxytocin and carbetocin, a synthetic oxytocin analogue. Carbetocin has a longer half-life when compared to oxytocin, resulting in a reduced use of additional uterotonics. Oxytocin is known to cause fewer cardiovascular side effects when administered as a short-infusion compared to as an intravenous bolus. Based on these findings, we aim at comparing carbetocin 100 mcg given as a slow intravenous bolus with carbetocin 100 mcg applied as a short-infusion in 100 ml 0.9 % sodium chloride in women undergoing a planned or unplanned caesarean delivery. We hypothesise uterine contraction not to be inferior to a bolus application (primary efficacy endpoint) and greater haemodynamic stability to be achieved after a short-infusion than after a bolus administration, as measured by heart rate and mean arterial blood pressure (primary safety endpoint).
METHODS: This is a prospective, double-blind, randomised controlled, investigator-initiated, non-inferiority trial taking place at the University Hospital Basel, Switzerland. Uterine tone is quantified by manual palpation by the obstetrician using a linear analogue scale from 0 to 100 at 2, 3, 5 and 10 minutes after cord clamping. We will evaluate whether the lower limit of the confidence interval for the difference of the maximal uterine tone within the first 5 minutes after cord clamping between both groups does not include the pre-specified non-inferiority limit of -10. Both haemodynamic secondary endpoints will be analysed using a linear regression model, adjusting for the baseline value and the dosage of vasoactive drug given between cord clamping and 1 minute thereafter, in order to investigate superiority of a short-infusion as compared to a bolus application. We will follow the extension of CONSORT guidelines for reporting the results of non-inferiority trials.
CONCLUSIONS: Haemodynamic stability and adequate uterine tone are important outcomes in caesarean sections. The results of this trial may be used to optimise these factors and thereby increase patient safety due to a reduction in cardiovascular side effects.
BACKGROUND: Clinicaltrials.gov NCT02221531 on 19 August 2014 and www.kofam.ch SNCTP000001197 on 15 November 2014.
METHODS: This is a prospective, double-blind, randomised controlled, investigator-initiated, non-inferiority trial taking place at the University Hospital Basel, Switzerland. Uterine tone is quantified by manual palpation by the obstetrician using a linear analogue scale from 0 to 100 at 2, 3, 5 and 10 minutes after cord clamping. We will evaluate whether the lower limit of the confidence interval for the difference of the maximal uterine tone within the first 5 minutes after cord clamping between both groups does not include the pre-specified non-inferiority limit of -10. Both haemodynamic secondary endpoints will be analysed using a linear regression model, adjusting for the baseline value and the dosage of vasoactive drug given between cord clamping and 1 minute thereafter, in order to investigate superiority of a short-infusion as compared to a bolus application. We will follow the extension of CONSORT guidelines for reporting the results of non-inferiority trials.
CONCLUSIONS: Haemodynamic stability and adequate uterine tone are important outcomes in caesarean sections. The results of this trial may be used to optimise these factors and thereby increase patient safety due to a reduction in cardiovascular side effects.
BACKGROUND: Clinicaltrials.gov NCT02221531 on 19 August 2014 and www.kofam.ch SNCTP000001197 on 15 November 2014.
摘要：
背景：剖宫产术中最常用的两种宫缩药物是催产素和卡贝缩宫素，合成催产素类似物.与催产素相比，卡贝缩宫素具有更长的半衰期，导致减少使用额外的子宫内膜。与作为静脉推注相比,催产素已知在作为短输注施用时引起较少的心血管副作用。基于这些发现,我们的目的是比较卡贝缩宫素100mcg作为缓慢静脉推注与卡贝缩宫素100mcg作为100ml0.9％氯化钠的短期输注在计划或计划外剖腹产的妇女中。我们假设子宫收缩不低于推注应用（主要疗效终点），短期输注后的血流动力学稳定性比推注后高。以心率和平均动脉血压（主要安全终点）衡量。
方法：这是一个前瞻性的，双盲,随机对照，调查员发起的，在巴塞尔大学医院进行的非劣效性试验，瑞士。在脐带夹紧后2、3、5和10分钟,由产科医生使用从0到100的线性模拟量表通过手动触诊来定量子宫张力。我们将评估两组之间在脐带夹闭后的前5分钟内最大子宫张力差异的置信区间下限是否不包括预先指定的非劣效性极限-10。两个血液动力学次要终点都将使用线性回归模型进行分析，调整基线值和血管活性药物的剂量在脐带夹闭和1分钟后，为了研究短期输注与推注应用相比的优越性。我们将遵循CONSORT指南的扩展，以报告非劣效性试验的结果。
结论：血流动力学稳定和适当的子宫张力是剖腹产的重要结果。该试验的结果可用于优化这些因素，从而由于心血管副作用的减少而增加患者的安全性。
背景：Clinicaltrials.govNCT02221531于2014年8月19日和www。Kofam.chSNCTP000001197于2014年11月15日。
方法：这是一个前瞻性的，双盲,随机对照，调查员发起的，在巴塞尔大学医院进行的非劣效性试验，瑞士。在脐带夹紧后2、3、5和10分钟,由产科医生使用从0到100的线性模拟量表通过手动触诊来定量子宫张力。我们将评估两组之间在脐带夹闭后的前5分钟内最大子宫张力差异的置信区间下限是否不包括预先指定的非劣效性极限-10。两个血液动力学次要终点都将使用线性回归模型进行分析，调整基线值和血管活性药物的剂量在脐带夹闭和1分钟后，为了研究短期输注与推注应用相比的优越性。我们将遵循CONSORT指南的扩展，以报告非劣效性试验的结果。
结论：血流动力学稳定和适当的子宫张力是剖腹产的重要结果。该试验的结果可用于优化这些因素，从而由于心血管副作用的减少而增加患者的安全性。
背景：Clinicaltrials.govNCT02221531于2014年8月19日和www。Kofam.chSNCTP000001197于2014年11月15日。
