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Restrictive versus Routine Episiotomy: A Multicenter Randomized Controlled Trial
17 Pages Posted: 24 Jun 2019
More...Abstract
Background: Episiotomy is an incision made during vaginal childbirth to widen the vagina. Episiotomy is recommended only for some patients based on 'restrictive episiotomy policy'. It remains debatable whether restrictive episiotomy could be extrapolated to Asian women due to limited data.
Methods: This randomized controlled trial compared routine and restrictive episiotomies among Thai women when a vaginal birth was anticipated. Participants were singleton, term-pregnant women with a cephalic presentation. Randomization was stratified by study site and parity. Primary outcome was severe perineal laceration. Secondary outcomes included vaginal laceration, cervical laceration, and pregnancy outcomes. Risk ratios (RR) and 95% confidence intervals (CI) were calculated to indicate between-group differences.
Findings: 1502 and 1504 women were randomly assigned to restrictive and routine episiotomy respectively. There was no difference in severe perineal laceration between the groups (RR 0·72; 95% CI 0·46-1·12). Restrictive episiotomy resulted in more intact perineum in multiparous women (RR 3·09; 95% CI 2·10-4·56). Restrictive episiotomy increased risk of vaginal laceration in either the primiparous (RR 1·96; 95% CI 1·62-2·37) or multiparous women (RR 2·21; 95% CI 1·77-2·75) but did not lead to more suturing. There were comparable risks of cervical laceration, postpartum hemorrhage, wound complication, birth asphyxia, and admission to neonatal intensive care unit.
Interpretation: Restrictive episiotomy results in more intact perineum after delivery in multiparous women. Risks of maternal and neonatal outcomes were comparable between the two practices. These results strengthen the certainty of the existing Cochrane review findings in supporting the use of restrictive episiotomy.
Trial Registration: The trial registration number of the protocol for this study was TCTR20150212001.
Funding Statement: Thailand Research Fund.
Declaration of Interests: The authors declare no competing interests.
Ethics Approval Statement: Ethical approval was obtained from the ethical committees (HE581111). This study was conducted and reported according to the CONSORT Statement.
Keywords: Episiotomy, restrictive, randomised controlled trial, perineal laceration
Suggested Citation: Suggested Citation