Translational Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Women & Children's Directorate, North Bristol NHS Trust, Bristol, UK.
BMC Pregnancy Childbirth. 2019 Apr 2;19(1):109. doi: 10.1186/s12884-019-2222-x.
Operative vaginal birth is a common procedure used to expedite birth after full cervical dilatation where there is a clinical need to do so (15% of births in the UK in 2016). The acquisition of skills for operative vaginal birth is dependent on the exposure of junior obstetricians to situations in which they can undertake directly supervised learning from senior accouchers. The Royal College of Obstetricians and Gynaecologists has recently introduced the first structured course in operative vaginal birth. To date, there have been no attempts to determine the clinical impact of a structured training package for operative vaginal birth.
The STROBE study is a quasi-experimental before-after interrupted time-series study of the effect of simulation training in operative vaginal birth for obstetricians on clinical outcomes of women and babies following operative vaginal birth. Similar to a stepped-wedge design, the intervention will be gradually implemented in all participating units but at different time periods. The primary outcome is failed operative vaginal birth with the first intended instrument. Secondary maternal outcomes are; use of second instrument to achieve operative vaginal birth, caesarean section, episiotomy, perineal trauma (1st, 2nd, 3rd, 4th degree tear), cervical tear requiring suturing, general anaesthesia and estimated blood loss. Secondary neonatal outcomes are; Apgar score at one, five, and ten minutes, Umbilical artery pH, shoulder dystocia, admission to Neonatal Intensive Care Unit and death within 28 days of birth. The analysis will be intention-to-treat (per unit) on the primary and secondary outcomes. The STROBE study received approval from the Health Research Authority and is sponsored by North Bristol NHS Trust. Results will be published in an open-access peer-reviewed medical journal within one year of completion of data gathering.
The STROBE study will help establish our understanding of the effectiveness of locally-delivered simulation training for operative vaginal birth. Robust evidence supporting the effectiveness of such an approach would add weight to the argument supporting regular, local training for junior obstetricians in operative vaginal birth.
ISRCTN11760611 05/03/2018 (retrospectively registered).
经阴道分娩是一种常见的分娩方式，适用于在完全宫颈扩张后需要加速分娩的情况（2016 年英国有 15%的分娩采用这种方式）。获得经阴道分娩技能取决于初级产科医生接触到可以直接从高级产科医生那里接受监督学习的情况。皇家妇产科医师学院最近推出了首个经阴道分娩操作的结构化课程。迄今为止，尚未有尝试确定经阴道分娩操作结构化培训包的临床影响。
STROBE 研究是一项关于模拟培训对产科医生经阴道分娩操作临床结局的影响的准实验前后、中断时间序列研究。类似于阶梯式楔形设计，干预措施将在所有参与单位逐步实施，但在不同时间段进行。主要结局是首次意图使用器械进行经阴道分娩失败。次要产妇结局是：使用第二器械实现经阴道分娩、剖宫产、会阴切开术、会阴损伤（1 度、2 度、3 度、4 度撕裂）、需要缝合的宫颈撕裂、全身麻醉和估计失血量。次要新生儿结局是：1 分钟、5 分钟和 10 分钟时的 Apgar 评分、脐动脉 pH 值、肩难产、新生儿重症监护病房入院和出生后 28 天内死亡。主要和次要结局的分析将按单位进行意向治疗（per unit）。STROBE 研究已获得英国健康研究管理局的批准，并由北布里斯托尔国民保健信托基金赞助。研究结果将在数据收集完成后一年内发表在开放获取的同行评议医学期刊上。
STROBE 研究将有助于我们了解局部提供的经阴道分娩操作模拟培训的有效性。支持这种方法有效的有力证据将为支持对经阴道分娩的初级产科医生进行常规、本地培训的论点提供支持。
ISRCTN83326163 2018 年 5 月 3 日（回顾性注册）。
