I Kamisan Atan1,2, K L Shek1,3, S Langer1, R Guzman Rojas4,5, J Caudwell-Hall1, J O Daly6, H P Dietz1. 1. Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia. 2. Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Kuala Lumpur, Malaysia. 3. Liverpool Clinical School, Liverpool Hospital, University of Western Sydney, Sydney, NSW, Australia. 4. Facultad de Medicina, Clínica Alemana - Universidad del Desarrollo, Santiago, Chile. 5. Hospital Clínico de la Universidad de Chile, Santiago, Chile. 6. Royal Prince Alfred Hospital, Sydney, NSW, Australia.
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. DESIGN: Multicentre prospective randomised controlled trial. SETTING:Two tertiary obstetric units in Australia. POPULATION: 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. MAIN OUTCOME MEASURES: 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). CONCLUSION: 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. TWEETABLE ABSTRACT: No evidence of a protective effect of the Epi-No(®) device on intrapartum pelvic floor rauma.
RCT Entities:
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. DESIGN: Multicentre prospective randomised controlled trial. SETTING: Two tertiary obstetric units in Australia. POPULATION: 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. MAIN OUTCOME MEASURES: 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). CONCLUSION: 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. TWEETABLE ABSTRACT: No evidence of a protective effect of the Epi-No(®) device on intrapartum pelvic floor rauma.
Authors: Francisco J Orejuela; Rajshi Gandhi; Lauren Mack; Wesley Lee; Haleh Sangi-Haghpeykar; Hans P Dietz; Susan M Ramin Journal: Int Urogynecol J Date: 2018-02-06 Impact factor: 2.894
Authors: Caroline W S Ferreira; Ixora K Atan; Andrew Martin; Ka Lai Shek; Hans Peter Dietz Journal: Int Urogynecol J Date: 2017-03-11 Impact factor: 2.894
Authors: Ixora Kamisan Atan; Sylvia Lin; Hans Peter Dietz; Peter Herbison; Peter Donald Wilson Journal: Int Urogynecol J Date: 2018-03-21 Impact factor: 2.894
Authors: José Antonio Sainz-Bueno; María José Bonomi; Carmen Suárez-Serrano; Esther M Medrano-Sánchez; Alberto Armijo; Ana Fernández-Palacín; José Antonio García-Mejido Journal: Quant Imaging Med Surg Date: 2022-04
Authors: Síssi Sisconeto de Freitas; Alana Leandro Cabral; Rogério de Melo Costa Pinto; Ana Paula Magalhães Resende; Vanessa Santos Pereira Baldon Journal: Int Urogynecol J Date: 2018-10-20 Impact factor: 2.894