A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study

Objective: To compare the maternal and neonatal outcomes of operative vaginal delivery in relation to the use of episiotomy. Design: Pilot randomised controlled trial (RCT). Setting: Two urban maternity units in Scotland and England. Sample: Nulliparous women anticipating a singleton cephalic vaginal delivery were recruited in the antenatal period. Methods: If an operative vaginal delivery was required in the second stage of labour, women were randomised to either routine (in all cases) or restrictive (only if tearing apparent) use of episiotomy. Main outcome measures: The primary outcome was anal sphincter tearing (third or fourth degree). Secondary outcomes included postpartum haemorrhage (PPH), neonatal trauma and pelvic floor symptoms up until 10 days postpartum. Results: In a group of 317 women requiring operative vaginal delivery, 200 were randomised: 99 to routine use of episiotomy and 101 to restrictive use. There were small differences in the rates of anal sphincter tears (8.1% routine versus 10.9% restrictive, OR 0.72, 95% CI 0.28-1.87) and primary PPH (36.4% routine versus 26.7% restrictive, OR 1.57, 95% CI 0.86-2.86). Neonatal trauma was similar between the two groups (45.5% routine versus 43.6% restrictive, OR 1.08, 95% CI 0.62-1.89), as was prolonged catheterisation, urinary incontinence, faecal incontinence, perineal infection and prolonged hospital admission. Conclusions: This pilot study does not provide conclusive evidence that a policy of routine episiotomy is better or worse than a restrictive policy. A definitive RCT is feasible but will require a large sample size to inform clinical practice.