Is it time to abandon episiotomy use? A randomized controlled trial (EPITRIAL).
Advanced perineal tears
Episiotomy
Journal
International urogynecology journal
ISSN: 1433-3023
Titre abrégé: Int Urogynecol J
Pays: England
ID NLM: 101567041
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
21
02
2020
accepted:
05
05
2020
pubmed:
26
5
2020
medline:
24
6
2021
entrez:
26
5
2020
Statut:
ppublish
Résumé
The objective of this trial was to evaluate whether avoidance of episiotomy can decrease the risk of advanced perineal tears. 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. 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). 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.
Identifiants
pubmed: 32448935
doi: 10.1007/s00192-020-04332-2
pii: 10.1007/s00192-020-04332-2
doi:
Banques de données
ClinicalTrials.gov
['NCT02356237']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2377-2385Commentaires et corrections
Type : CommentIn
Type : CommentIn
Références
Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017;2:CD000081.
Biguzzi E, Franchi F, Ambrogi F, Ibrahim B, Bucciarelli P, Acaia B, et al. Risk factors for postpartum hemorrhage in a cohort of 6011 Italian women. Thromb Res. 2012;129(4):e1–7.
Amorim Francisco A, Junqueira Vasconcellos de Oliveira SM, Barbosa da Silva FM, Bick D, Gonzalez Riesco ML. Women's experiences of perineal pain during the immediate postnatal period: a cross-sectional study in Brazil. Midwifery. 2011;27(6):e254–9.
pubmed: 21145149
Espuna-Pons M, Solans-Domenech M, Sanchez E. Double incontinence in a cohort of nulliparous pregnant women. Neurourol Urodyn. 2012;31(8):1236–41.
Sagi-Dain L, Sagi S. Morbidity associated with episiotomy in vacuum delivery: a systematic review and meta-analysis. BJOG: Int J Obstet Gynaecol. 2015;122(8):1073–81.
Sagi-Dain L, Sagi S. The role of episiotomy in prevention and management of shoulder dystocia: a systematic review. Obstet Gynecol Survey. 2015;70(5):354–62.
ACOG Practice Bulletin No. 198: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstetrics Gynecol. 2018; 132(3):e87-e102.
Kartal B, Kizilirmak A, Calpbinici P, Demir G. Retrospective analysis of episiotomy prevalence. J Turkish German Gynecol Assoc. 2017;18(4):190–4.
Sagi-Dain L, Sagi S. Episiotomy knowledge, attitudes and practice: a crosssectional survey of four public Israeli hospitals and review of the literature. Evidence Based Midwifery. 2015;13(4):138–42.
Pergialiotis V, Vlachos D, Protopapas A, Pappa K, Vlachos G. Risk factors for severe perineal lacerations during childbirth. Int J Gynaecol Obstet:Off Organ Int Federation Gynaecol Obstetrics. 2014;125(1):6–14.
Clesse C, Lighezzolo-Alnot J, De Lavergne S, Hamlin S, Scheffler M. Statistical trends of episiotomy around the world: comparative systematic review of changing practices. Health Care Women Int. 2018;39(6):644–62.
pubmed: 29509098
Sagi-Dain L, Bahous R, Caspin O, Kreinin-Bleicher I, Gonen R, Sagi S. No episiotomy versus selective lateral/mediolateral episiotomy (EPITRIAL): an interim analysis. Int Urogynecol J. 2018;29(3):415–23.
pubmed: 28932882
pmcid: 28932882
MA M, Coutinho IC, Melo I, Katz L. Selective episiotomy vs. implementation of a non-episiotomy protocol: a randomized clinical trial. Reprod Health. 2017;14(1):55.
Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, Group C. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. Jama. 2012;308(24):2594–604.
pubmed: 23268518
Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003;14(3):164–8 discussion 8.
pubmed: 12955337
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005;193(1):103–13.
pubmed: 16021067
Carroli G, Mignini L. Episiotomy for vaginal birth. The Cochrane database of systematic reviews. 2009(1):CD000081.
Royal College of Obstetricians and Gynaecologists. The Management of Third- and Fourth-Degree Perineal Tears. 2015. Accessible from https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-29.pdf .
Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, et al. Obstetrical anal sphincter injuries (OASIS): prevention, recognition, and repair. Journal of obstetrics and gynaecology Canada : JOGC =. J d'Obstet et Gynecol du Canada: JOGC. 2015;37(12):1131–48.
Sagi-Dain L, Sagi S. Indications for episiotomy performance - a cross-sectional survey and review of the literature. J Obstet Gynaecol: J Institute Obstet Gynaecol. 2016;36(3):361–5.
Raisanen S, Vehvilainen-Julkunen K, Heinonen S. Need for and consequences of episiotomy in vaginal birth: a critical approach. Midwifery. 2010;26(3):348–56.
pubmed: 18804317
Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013;13:59.
pubmed: 3599825
pmcid: 3599825
Lund NS, Persson LK, Jango H, Gommesen D, Westergaard HB. Episiotomy in vacuum-assisted delivery affects the risk of obstetric anal sphincter injury: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2016;207:193–9.
Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study. BJOG: Int J Obstet Gynaecol. 2008;115(13):1695–702 discussion 702-3.
Tsakiridis I, Giouleka S, Mamopoulos A, Athanasiadis A, Daniilidis A, Dagklis T. Operative vaginal delivery: a review of four national guidelines. J Perinat Med. 2020;48(3):189–98.
pubmed: 31926101
Hobson S, Cassell K, Windrim R, Cargill Y. No. 381 – Assisted vaginal birth. J Obstet Gynaecol Can 2019;41:870–882.
Sagi-Dain L, Sagi S. The correct episiotomy: does it exist? A cross-sectional survey of four public Israeli hospitals and review of the literature. Int Urogynecol J. 2015;26(8):1213–9.
pubmed: 25831995