Department of Gynaecology and Obstetrics, Academic Medical Centre, Amsterdam, the Netherlands.
BMC Pregnancy Childbirth. 2010 May 10;10:20. doi: 10.1186/1471-2393-10-20.
Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV) and the Dutch Society for Obstetrics and Gynaecology (NVOG). Implementation of ECV does not exceed 50 to 60% and probably less.We aim to improve the implementation of ECV to decrease maternal and neonatal morbidity and mortality due to breech presentations. This will be done by defining barriers and facilitators of implementation of ECV in the Netherlands. An innovative implementation strategy will be developed based on improved patient counselling and thorough instructions of health care providers for counselling.
METHOD/DESIGN: The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV.The first phase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to inform and counsel pregnant women with a breech presentation, and to inform and educate care providers. In the third phase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices. Primary endpoints are number of counselled women. Secondary endpoints are process indicators, the amount of fetes in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured.
This study will provide evidence for the cost effectiveness of a structural implementation of external cephalic versions to reduce the number of breech presentations at term.
Dutch Trial Register (NTR): 1878.
臀位分娩在所有足月妊娠中占 3%至 4%。经阴道外倒转术（ECV）已被证实可有效预防阴道臀位分娩，因此被荷兰皇家助产士组织（KNOV）和荷兰妇产科协会（NVOG）的临床指南推荐。但 ECV 的实施率不超过 50%至 60%，可能更低。我们旨在通过确定荷兰 ECV 实施的障碍和促进因素来提高 ECV 的实施率，以降低因臀位分娩导致的母婴发病率和死亡率。这将通过定义 ECV 在荷兰的实施障碍和促进因素来实现。将基于改进的患者咨询和对医疗保健提供者咨询的彻底指导，制定一项创新的实施策略。
方法/设计：本实施研究的最终目的是改善对孕妇的咨询和临床医生的信息，以实现更好的 ECV 实施。项目的第一阶段是检测 ECV 的障碍和促进因素。下一步是制定一项实施策略，为有臀位表现的孕妇提供信息和咨询，并为医护人员提供信息和教育。在第三阶段，将在一项随机试验中评估所开发实施策略的有效性。研究人群是随机选择的来自 60 至 100 家医院和诊所的助产士和妇科医生。主要终点是咨询过的妇女人数。次要终点是过程指标，即出生时胎头位置的胎儿数量、ECV 相关并发症、剖宫产数量以及母婴围产期状况。将测量实施策略的成本效益。
本研究将为结构性实施经阴道外倒转术以减少足月臀位分娩的数量提供成本效益证据。
荷兰试验注册（NTR）：1878。
