Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL)
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ORIGINAL ARTICLE
Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL) Lena Sagi-Dain 1,2 & Inna Kreinin-Bleicher 3 & Rabia Bahous 3 & Noga Gur Arye 3 & Tamar Shema 3 & Aya Eshel 3 & Orna Caspin 3 & Ron Gonen 2,3 & Shlomi Sagi 3 Received: 21 February 2020 / Accepted: 5 May 2020 # The International Urogynecological Association 2020
Abstract Introduction and hypothesis The objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears. Methods In this randomized (1:1) parallel-group superiority trial, primiparous women underwent randomization into “avoidance of episiotomy” (the study group in which episiotomy was allowed only in cases of fetal distress) or “standard care.” The primary outcome was the incidence of advanced (3rd- and 4th-degree) perineal tears. Results The participants were randomized into “standard care” (n = 337) vs. “no episiotomy” (n = 339) groups, not differing in any demographic or obstetric characteristics. Episiotomy rates were significantly lower in the study group (19.6%) compared with the standard care group (29.8%, p = 0.004). Five (1.5%) advanced tears were diagnosed in the study group vs. ten = 3.0% in the controls, yielding an odds ratio of 0.50 (95% CI 0.17–1.50) in favor of the “no episiotomy” group (p = 0.296). No differences were noted in any secondary outcomes. By per protocol analysis (omitting cases in which episiotomy was performed for indications other than fetal distress in the study group), a trend to decreased risk of advanced tears in the study group was noted (p = 0.0956). By per protocol analyses, no severe tears were noted in the 53 vacuum deliveries in the study group vs. 4/65 (6.2%) tears in the controls (p = 0.126). Conclusions Since decreased use of episiotomy was not associated with higher rates of severe tears or any other adverse outcomes, we believe this procedure can be avoided in spontaneous as well as vacuum-assisted deliveries. Trial registration no. NCT02356237. Keywords Advanced perineal tears . Episiotomy
Introduction During the past century, episiotomy has become one of the most prevalent interventions in the delivery room. However, Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00192-020-04332-2) contains supplementary material, which is available to authorized users. * Lena Sagi-Dain [email protected] 1
Department of Obstetrics and Gynecology, Carmel Medical Center, 7 Michal St., Haifa, Israel
2
The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
3
Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Haifa, Israel
accumulating evidence has failed to prove any of the presumed benefits of this procedure; furthermore, episiotomy might be associated with an increased rate of maternal complications, such as higher risk of severe perineal trauma, postpartum hemorrhage, perineal pain and anal incontinence [1–4]. Systematic reviews demonstrated no solid evid
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