BACKGROUND Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries. METHODS OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland and Italy. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration. The intervention involved evidence-based education of clinicians and women with one previous caesarean section (CS), appointment of opinion leaders, audit/peer review, and joint discussions by women and clinicians. Control sites provided usual care. Primary outcome was annual hospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October 2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940 women. RESULTS The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was no statistically significant difference in the change in the proportion of women having a VBAC between intervention sites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences between intervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI: 0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited women with birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782 in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000. CONCLUSIONS Changing clinical practice takes time. As elective repeat CS is the most common reason for CS in multiparous women, interventions that are feasible and safe and that have been shown to lead to decreasing repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. This may best be done using an implementation science approach that can modify evidence-based interventions in response to changing clinical circumstances. TRIAL REGISTRATION The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.

中文翻译：

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OptiBIRTH：一项针对增加剖腹产后阴道分娩的复杂干预措施的整群随机试验。

背景 尽管有证据支持剖腹产后阴道分娩 (VBAC) 的安全性，但许多国家的比率较低。方法 OptiBIRTH 通过在德国、爱尔兰和意大利 15 个 VBAC 率 < 35% 的产科单位进行非盲整群随机试验，调查了旨在提高 VBAC 率的以女性为中心的干预措施的效果。根据年出生人数和 VBAC 率将研究中心配对或三胞胎进行匹配，并在试验注册后以 1:1 或 2:1 的比例随机分配干预与对照。干预措施包括对临床医生和曾进行过剖腹产手术 (CS) 的妇女进行循证教育、任命意见领袖、审计/同行评审以及妇女和临床医生的联合讨论。控制点提供常规护理。主要结果是试验前（2012 年）与试验最后一年（2016 年）的年度医院水平 VBAC 率。2014 年 4 月至 2015 年 10 月期间，招募了 2002 名妇女（干预组 1195 名，对照组 807 名），并提供了 1940 名妇女的出生方式数据。结果 OptiBIRTH 干预措施在三个国家的医院环境中都是可行且安全的。干预地点（2012 年为 25.6%，2016 年为 25.1%）和对照地点（18.3% 至 22.3%）之间，患有 VBAC 的女性比例变化没有统计学上的显着差异（根据干预和对照之间的差异调整优势比）组（2012 年）以及各国地点 VBAC 率的同质性：0.87，95% CI：0.67，1.14，p = 0.32，基于 5674 名妇女（2012 年）和 5284 名妇女（2016 年）的结果数据。数据显示，干预组发生>24周围生儿死亡4/1147例（0.34%），对照组4/782例（0.51%），子宫破裂2例（每组1例），发生率为1:1000。结论 改变临床实践需要时间。由于选择性重复 CS 是多产妇女 CS 的最常见原因，因此应推广可行、安全且已被证明可减少重复 CS 的干预措施。继续研究以完善最佳方案促进 VBAC 的方法至关重要。这最好使用实施科学方法来完成，该方法可以根据不断变化的临床情况修改循证干预措施。试验注册 OptiBIRTH 试验于 2013 年 3 月 4 日注册。试用注册号 ISRCTN10612254。