首页> 外文OA文献 >Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.
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Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

机译:研究方案。 ECSSIT-选择性剖宫产Syncincinon输液试验。催产素(Syntocinon)5 IU推注和安慰剂输注与催产素5 IU推注和40 IU输注控制选择性剖宫产术失血的多中心随机对照试验。

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摘要

BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at elective caesarean section. Safe operative delivery is now a priority and a reality for many pregnant women. Obstetricians, obstetric anaesthetists, midwives and pregnant women need high quality evidence on which to base management approaches. The overall aim is to reduce maternal haemorrhagic morbidity and its attendant risks at elective caesarean section. TRIAL REGISTRATION: number: ISRCTN17813715.
机译:背景:剖宫产术是全世界女性最常做的主要手术之一。利率正在上升,美利坚合众国,英国,中国和爱尔兰共和国的研究报告利率在20%至25%之间。手术发病率包括出血,贫血,输血,严重者包括产妇死亡。常规催产药在阴道分娩第三阶段的价值已得到公认,并已假定这些益处也适用于剖腹产。建议在剖腹产分娩后缓慢推注催产素。某些临床医生会在手术后再使用催产素进一步输液。静脉催产素的半衰期非常短(4-10分钟),因此,输注催产素的潜在优势在于,在大多数原发性出血发生时,它在整个手术过程中和产后立即保持子宫收缩力。迄今为止,针对防止剖腹产出血的最佳方法的少数试验还不足以评估临床上重要的结局。迄今为止,尚无试验比较催产素静脉缓慢推注与催产素推注和输注的使用。方法与设计:提出了一项多中心随机对照试验。这项研究将在爱尔兰的五个大型妇产科进行,产科和麻醉学领域的学者和临床医生之间将进行合作。它将有2000名妇女在妊娠36周后接受选择性剖腹产。主要的预后指标将是大出血(失血量> 1000 ml)。一项涉及2000名女性的研究将有80%的能力使用两侧5%的alpha来检测重大出血风险的36%相对变化。讨论:评估选择性剖宫产第三阶段的最佳治疗方法既重要又及时。对于许多孕妇而言,安全的手术分娩现已成为重中之重。产科医生,产科麻醉师,助产士和孕妇需要高质量的证据作为管理方法的基础。总体目标是减少孕妇剖腹产的出血性疾病及其伴随的风险。试用注册:编号:ISRCTN17813715。

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