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Simulation TRaining for Operative vaginal Birth Evaluation: study protocol for an observational stepped-wedge interrupted time-series study (STROBE)

Research output: Contribution to journalArticle

Original languageEnglish
JournalBMC Pregnancy and Childbirth
DatePublished - 2 May 2019


Background: 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.
Methods: 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.
Discussion: 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.


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