title: Does the Epi-No(®) birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial.
abstract: OBJECTIVE
  Vaginal childbirth may result in levator ani injury secondary to overdistension during the second stage of labour. Other injuries include perineal and anal sphincter tears. Antepartum use of a birth trainer may prevent such injuries by altering the biomechanical properties of the pelvic floor. This study evaluates the effects of Epi-No(®) use on intrapartum pelvic floor trauma.
  
  
  METHODS
  Multicentre prospective randomised controlled trial.
  
  
  METHODS
  Two tertiary obstetric units in Australia.
  
  
  METHODS
  Nulliparous women carrying an uncomplicated singleton term pregnancy.
  
  
  METHODS
  Participants were assessed clinically and with 4D translabial ultrasound in the late third trimester, and again at 3-6 months postpartum. Women randomised to the intervention group were asked to use the Epi-No(®) device from 37 weeks of gestation until delivery.
  
  
  METHODS
  Levator ani, anal sphincter, and perineal trauma diagnosed clinically and/or with translabial ultrasound imaging.
  
  
  RESULTS
  Of 660 women randomised, 504 (76.4%) returned for assessment at a mean of 5 months postpartum. There was no significant difference in the incidence of levator avulsion [12 versus 15%; relative risk (RR) 0.82, 95% confidence interval (95% CI) 0.51-1.32; absolute risk reduction (ARR) 0.03, 95% CI -0.04 to 0.09; P = 0.39], irreversible hiatal overdistension (13 versus 15%; RR 0.86, 95% CI 0.52-1.42; ARR 0.02, 95% CI -0.05 to 0.09; P = 0.51), clinical anal sphincter trauma (7 versus 6%; RR 1.12, 95% CI 0.49-2.60; ARR -0.01, 95% CI -0.05 to 0.06; P = 0.77), and perineal tears (51 versus 53%; RR 0.96, 95% CI 0.78-1.17; ARR 0.02, 95% CI -0.08 to 0.13; P = 0.65). A marginally higher rate of significant defects of the external anal sphincter on ultrasound was observed in the intervention group (21 versus 14%; RR 1.44, 95% CI 0.97-2.20; ARR -0.06, 95% CI -0.13 to 0.05; P = 0.07).
  
  
  CONCLUSIONS
  Antenatal use of the Epi-No(®) device is unlikely to be clinically beneficial in the prevention of intrapartum levator ani damage, or anal sphincter and perineal trauma.
  
  
  CONCLUSIONS
  No evidence of a protective effect of the Epi-No(®) device on intrapartum pelvic floor rauma.
authors.affiliation: Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.|Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Kuala Lumpur, Malaysia.
authors.forename: I
authors.initials: I
authors.lastname: Kamisan Atan
authors.affiliation: Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.|Liverpool Clinical School, Liverpool Hospital, University of Western Sydney, Sydney, NSW, Australia.
authors.forename: K L
authors.initials: KL
authors.lastname: Shek
authors.affiliation: Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Langer
authors.affiliation: Facultad de Medicina, Clínica Alemana - Universidad del Desarrollo, Santiago, Chile.|Hospital Clínico de la Universidad de Chile, Santiago, Chile.
authors.forename: R
authors.initials: R
authors.lastname: Guzman Rojas
authors.affiliation: Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Caudwell-Hall
authors.affiliation: Royal Prince Alfred Hospital, Sydney, NSW, Australia.
authors.forename: J O
authors.initials: JO
authors.lastname: Daly
authors.affiliation: Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
authors.forename: H P
authors.initials: HP
authors.lastname: Dietz
mesh_terms: D000293:Adolescent; D000328:Adult; D001003:Anal Canal / Q000000981:diagnostic imaging / Q000293:injuries*; D036861:Delivery, Obstetric; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D022125:Lacerations / Q000000981:diagnostic imaging / Q000517:prevention & control*; D008875:Middle Aged; D007744:Obstetric Labor Complications / Q000000981:diagnostic imaging / Q000517:prevention & control*; D036801:Parturition; D017773:Pelvic Floor / Q000000981:diagnostic imaging / Q000293:injuries*; D010502:Perineum / Q000293:injuries*; D011247:Pregnancy; D011295:Prenatal Care / Q000379:methods; D011446:Prospective Studies; D014463:Ultrasonography; D055815:Young Adult
keywords: Anal sphincter tear; Epi-No®; levator avulsion; pelvic floor trauma; perineal trauma