UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.
Lancet. 2012 May 5;379(9827):1721-7. doi: 10.1016/S0140-6736(12)60206-2. Epub 2012 Mar 6.
Active management of the third stage of labour reduces the risk of post-partum haemorrhage. We aimed to assess whether controlled cord traction can be omitted from active management of this stage without increasing the risk of severe haemorrhage.
We did a multicentre, non-inferiority, randomised controlled trial in 16 hospitals and two primary health-care centres in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Women expecting to deliver singleton babies vaginally (ie, not planned caesarean section) were randomly assigned (in a 1:1 ratio) with a centrally generated allocation sequence, stratified by country, to placental delivery with gravity and maternal effort (simplified package) or controlled cord traction applied immediately after uterine contraction and cord clamping (full package). After randomisation, allocation could not be concealed from investigators, participants, or assessors. Oxytocin 10 IU was administered immediately after birth with cord clamping after 1-3 min. Uterine massage was done after placental delivery according to local policy. The primary (non-inferiority) outcome was blood loss of 1000 mL or more (severe haemorrhage). The non-inferiority margin for the risk ratio was 1·3. Analysis was by modified intention-to-treat, excluding women who had emergency caesarean sections. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN 12608000434392.
Between June 1, 2009, and Oct 30, 2010, 12,227 women were randomly assigned to the simplified package group and 12,163 to the full package group. After exclusion of women who had emergency caesarean sections, 11,861 were in the simplified package group and 11,820 were in the full package group. The primary outcome of blood loss of 1000 mL or more had a risk ratio of 1·09 (95% CI 0·91-1·31) and the upper 95% CI limit crossed the pre-stated non-inferiority margin. One case of uterine inversion occurred in the full package group. Other adverse events were haemorrhage-related.
Although the hypothesis of non-inferiority was not met, omission of controlled cord traction has very little effect on the risk of severe haemorrhage. Scaling up of haemorrhage prevention programmes for non-hospital settings can safely focus on use of oxytocin.
United States Agency for International Development and UN Development Programme/UN Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research.
积极管理第三产程可降低产后出血风险。本研究旨在评估在不增加严重出血风险的情况下，是否可以省略第三产程中控制性脐带牵拉。
我们在阿根廷、埃及、印度、肯尼亚、菲律宾、南非、泰国和乌干达的 16 家医院和 2 家初级保健中心开展了一项多中心、非劣效性、随机对照试验。研究对象为预计经阴道分娩（即非计划性剖宫产）的单胎孕妇，按 1:1 比例随机分配（中心生成的分配序列），接受重力胎盘娩出和产妇努力（简化方案）或子宫收缩和脐带夹闭后立即进行控制性脐带牵拉（完整方案）。随机分组后，研究者、参与者和评估者均无法隐藏分组。胎儿娩出后 1-3 分钟夹闭脐带，立即给予 10IU 缩宫素。根据当地政策，胎盘娩出后进行子宫按摩。主要（非劣效性）结局为失血量≥1000mL（严重出血）。风险比的非劣效性边界为 1.3。采用意向治疗进行分析，排除紧急剖宫产的妇女。本试验在澳大利亚和新西兰临床试验注册中心注册，注册号为 ACTRN 12608000434392。
2009 年 6 月 1 日至 2010 年 10 月 30 日期间，共有 12227 名妇女被随机分配至简化方案组，12163 名妇女被随机分配至完整方案组。排除紧急剖宫产的妇女后，简化方案组有 11861 名妇女，完整方案组有 11820 名妇女。主要结局为失血量≥1000mL 的风险比为 1.09（95%CI 0.91-1.31），上 95%CI 限超过了预设的非劣效性边界。完整方案组发生 1 例子宫内翻。其他不良事件与出血相关。
虽然未达到非劣效性假设，但省略控制性脐带牵拉对严重出血风险的影响很小。扩大非医院环境下的出血预防计划可以安全地将重点放在使用缩宫素上。
美国国际开发署和联合国开发计划署/联合国人口基金/世界卫生组织/世界银行生殖健康与研究特别方案、生殖健康研究与发展方案。
