Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial
Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial
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DOI：
10.1111/j.1471-0528.2010.02648.x
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发表时间：
2010-09-01
影响因子：
5.8
通讯作者：
Rudigoz, R.
中科院分区：
文献类型：
--
作者：
Deneux-Tharaux, C.;Dupont, C.;Rudigoz, R.
目的降低严重产后出血(PPH)的发生率是一项重大的产科挑战。这些通常被认为与不符合标准的初始护理有关。必须评估增加PPH早期管理的适当性的战略。我们测试了这样的假设，即旨在增加PPH早期管理方案在实践中的多方面干预将减少严重PPH的发生率。设计成组随机试验。人口在法国六个地区的106个产科单元。方法产妇单元被随机分配接受干预，或被动传播方案。干预结合了外展访问，以讨论每个当地背景下的方案、提醒和对严重事件的同行审查，并由一个由产科医生和助产士配对的团队在每个妇产医院实施。主要结果是严重产后出血的发生率，定义为以下一项或多项的综合：输血、栓塞术、外科手术、转到重症监护、围产期血红蛋白降低4g/dl或以上、死亡。结果干预单位重度PPH的平均发生率为1.64%(SD 0.80)，对照组为1.65%(SD 0.96)，差异无统计学意义。干预单位对产后出血管理的某些要素的使用频率较高，如高层人员的帮助(P=0.005.0 5)，或倾向于二线药物治疗(P=0.0 6)、及时验血(P=0.0 9)。结论与对照单位相比，此次教育干预虽然改善了一些做法，但对重度产后出血的发生率并无影响。
ObjectiveDecreasing the prevalence of severe postpartum haemorrhages (PPH) is a major obstetrical challenge. These are often considered to be associated with substandard initial care. Strategies to increase the appropriateness of early management of PPH must be assessed. We tested the hypothesis that a multifaceted intervention aimed at increasing the translation into practice of a protocol for early management of PPH, would reduce the incidence of severe PPH.DesignCluster-randomised trial.Population106 maternity units in six French regions.MethodsMaternity units were randomly assigned to receive the intervention, or to have the protocol passively disseminated. The intervention combined outreach visits to discuss the protocol in each local context, reminders, and peer reviews of severe incidents, and was implemented in each maternity hospital by a team pairing an obstetrician and a midwife.Main outcome measuresThe primary outcome was the incidence of severe PPH, defined as a composite of one or more of: transfusion, embolisation, surgical procedure, transfer to intensive care, peripartum haemoglobin decrease of 4 g/dl or more, death. The main secondary outcomes were PPH management practices.ResultsThe mean rate of severe PPH was 1.64% (SD 0.80) in the intervention units and 1.65% (SD 0.96) in control units; difference not significant. Some elements of PPH management were applied more frequently in intervention units-help from senior staff (P = 0.005), or tended to - second-line pharmacological treatment (P = 0.06), timely blood test (P = 0.09).ConclusionThis educational intervention did not affect the rate of severe PPH as compared with control units, although it improved some practices.