A Randomized Controlled Trial of Routine Versus Restrictive Use of Episiotomy at Operative Vaginal Delivery: A Multicentre Pilot Study

Abstract

The use of episiotomy as a routine component of operative vaginal delivery (OVD) is decreasing. Although a majority of physicians believe that routine use of episiotomy at OVD is protective against anal sphincter tears, the evidence on this issue is conflicting. A recent large retrospective Dutch study reported that episiotomy was highly protective against anal sphincter tears. This randomized controlled pilot study compared the maternal and neonatal outcomes of routine versus restrictive use of episiotomy at OVD in 200 nulliparous women expected to deliver at ≥37 weeks of gestation with live singleton cephalic pregnancies. The women were recruited in the antenatal period at 2 urban maternity units in Scotland and England between 2004 and 2006. Of the 200 study subjects, 99 were randomized to routine use of episiotomy (in all cases) and 101 to restrictive use of episiotomy (only if tearing becomes apparent). Anal sphincter tearing (third or fourth degree) was the primary outcome. Compared with restrictive use of episiotomy, routine use was associated with only a small and statistically insignificant difference in the rate of anal sphincter tears (8.1% routine vs. 10.9% restrictive); the odds ratio (OR) was 0.72, with a 95% confidence interval (CI) of 0.28 to 1.87. Routine use of episiotomy was associated with a slight but statistically insignificant increase in the incidence of both primary postpartum hemorrhage: 36.4% routine vs. 26.7% restrictive, with an OR of 1.57 and a 95% CI of 0.86 to 2.86, and neonatal trauma: 45.5% routine versus 43.6% restrictive, with an OR 1.08 and a 95% CI of 0.62 to 1.89. There were also no statistically meaningful differences between the 2 groups in prolonged postnatal stay, prolonged catheterization, urinary or fecal incontinence, perineal infection, rates of shoulder dystocia, or pain requiring moderate or strong analgesia. The findings of this small pilot study provide no evidence to support a policy of either routine or restrictive use of episiotomy at OVD and suggest the need for a large randomized controlled trial.