OptiBIRTH：一项增加剖宫产术后阴道分娩的复杂干预措施的整群随机试验。

OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.

机构信息

Queen's University Belfast, Belfast, Northern Ireland, UK.

National University of Ireland Galway, Galway, Ireland.

出版信息

BMC Pregnancy Childbirth. 2020 Mar 6;20(1):143. doi: 10.1186/s12884-020-2829-y.

DOI:10.1186/s12884-020-2829-y

PMID:32138712

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7059398/

Abstract

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.

摘要

背景

尽管有证据支持剖宫产后阴道分娩（VBAC）的安全性，但在许多国家，VBAC 的比例仍然很低。

方法

OptiBIRTH 研究了一项以女性为中心的干预措施的效果，该措施旨在通过在德国、爱尔兰和意大利的 15 个产科单位进行非盲、集群随机试验来提高 VBAC 率。这些单位根据年度分娩数量和 VBAC 率进行配对或成组随机分组，干预组与对照组的比例为 1:1 或 2:1。在试验注册后，采用基于证据的临床医生和有过一次剖宫产的女性教育、任命意见领袖、审核/同行审查以及女性和临床医生的联合讨论。对照组提供常规护理。主要结局是试验前（2012 年）和试验最后一年（2016 年）的医院年度 VBAC 率。2014 年 4 月至 2015 年 10 月，共招募了 2002 名妇女（干预组 1195 名，对照组 807 名），其中 1940 名妇女的分娩方式数据可用。

结果

在三个国家的医院环境中，OptiBIRTH 干预措施是可行且安全的。干预组（2012 年为 25.6%，2016 年为 25.1%）和对照组（18.3%至 22.3%）的 VBAC 比例变化没有统计学意义（调整了干预组和对照组之间的差异（2012 年）和国家内各单位 VBAC 率的同质性的比值比（2012 年）：0.87，95%CI：0.67，1.14，p=0.32，基于 5674 名（2012 年）和 5284 名（2016 年）有结局数据的妇女。在有分娩数据的招募妇女中，干预组有 4/1147 例围产儿死亡（>24 周）（0.34%），对照组有 4/782 例（0.51%），两组各有 1 例子宫破裂（每组 1 例），发生率为 1:1000。