背景:有一个新的需要,系统地调查希腊剖宫产率增加的原因,并采取干预措施,以大幅降低剖宫产率。为此,将探讨参与的希腊产科医生在管理劳动时遵循循证指南并应对其他教育和行为干预措施的能力,以及障碍和推动者。本文讨论的是希腊产科的阶梯式楔形设计干预试验的方案,并牢记上述目标,名为ENGAGE(希腊的ENhancinGvaginaldelevery)。
方法:希腊的22个选定的产妇单位将参加一项涉及20,000至25,000个分娩的多中心阶梯式随机前瞻性试验,其中两个人每月进入研究的干预期(逐步随机化)。进入研究的产妇护理单位将根据他们进入研究干预阶段的时间将建议的干预措施应用8-18个月。研究的初始阶段还将持续8至18个月,包括观察和记录常规实践(剖宫产,阴道分娩,以及参与单位的孕产妇和围产期发病率和死亡率)。第二阶段,干预期,将包括诸如HSOG(希腊妇产科学会)劳动管理指南的应用等干预措施,关于正确解释心电图的培训,处理阴道分娩中的紧急情况,虽然指导委员会成员将可以讨论和实施组织和行为的变化,回答问题,澄清相关问题,并在定期访问或视频会议期间向参与的医疗保健专业人员提供实际指导。此外,在研究过程中,结果将提供给参与单位,以便他们监测自己的表现,同时也收到关于他们费率的反馈。该研究的最后2个月阶段将致力于完成随访问卷,其中包含干预期结束后发生的孕产妇和新生儿发病率数据。研究的总持续时间估计为28个月。评估的主要结果将是剖宫产率的变化,次要结果将是孕产妇和新生儿的发病率和死亡率。
结论:该研究预计将产生有关影响的新信息,优势,可能性,以及持续的临床参与和行为实施的挑战,教育,和组织干预措施在希腊剖宫产手术方案中详细描述。这些结果可能会对提高孕产妇和新生儿护理质量的方法产生新的见解,特别是因为这代表了降低希腊高剖宫产率的共同努力,此外,为他们在其他国家的减少指明了道路。
背景:NCT04504500(ClinicalTrials.gov)。该试验进行了前瞻性登记。伦理参考号:320/23.6.2020,生物伦理和行为委员会,医学院,雅典国立和卡波迪斯大学,雅典,希腊。
BACKGROUND: There is an emerging need to systematically investigate the causes for the increased cesarean section rates in Greece and undertake interventions so as to substantially reduce its rates. To this end, the ability of the participating Greek obstetricians to follow evidence-based guidelines and respond to other educational and behavioral interventions while managing labor will be explored, along with barriers and enablers. Herein discussed is the protocol of a stepped-wedge designed intervention trial in Greek maternity units with the aforementioned goals in mind, named ENGAGE (ENhancinG vAGinal dElivery in Greece).
METHODS: Twenty-two selected maternity units in Greece will participate in a multicenter stepped-wedge randomized prospective trial involving 20,000 to 25,000 births, with two of them entering the intervention period of the study each month (stepped randomization). The maternity care units entering the study will apply the suggested interventions for a period of 8-18 months depending on the time they enter the intervention stage of the study. There will also be an initial phase of the study lasting from 8 to 18 months including observation and recording of the routine practice (cesarean section, vaginal birth, and maternal and perinatal morbidity and mortality) in the participating units. The second phase, the intervention period, will include such interventions as the application of the HSOG (the Hellenic Society of Obstetrics and Gynecology) Guidelines on labor management, training on the correct interpretation of cardiotocography, and dealing with emergencies in vaginal deliveries, while the steering committee members will be available to discuss and implement organizational and behavioral changes, answer questions, clarify relevant issues, and provide practical instructions to the participating healthcare professionals during regular visits or video conferences. Furthermore, during the study, the results will be available for the participating units in order for them to monitor their own performance while also receiving feedback regarding their rates. Τhe final 2-month phase of the study will be devoted to completing follow-up questionnaires with data concerning maternal and neonatal morbidities that occurred after the completion of the intervention period. The total duration of the study is estimated at 28 months. The primary outcome assessed will be the cesarean section rate change and the secondary outcomes will be maternal and neonatal morbidity and mortality.
CONCLUSIONS: The study is expected to yield new information on the effects, advantages, possibilities, and challenges of consistent clinical engagement and implementation of behavioral, educational, and organizational interventions described in detail in the protocol on cesarean section practice in Greece. The results may lead to new insights into means of improving the quality of maternal and neonatal care, particularly since this represents a shared effort to reduce the high cesarean section rates in Greece and, moreover, points the way to their reduction in other countries.
BACKGROUND: NCT04504500 (ClinicalTrials.gov). The trial was prospectively registered. Ethics Reference No: 320/23.6.2020, Bioethics and Conduct Committee, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.