Does the Epi-No® birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial

Ixora Kamisan @ Atan, K. L. Shek, S. Langer, R. Guzman Rojas, J. Caudwell-Hall, J. O. Daly, H. P. Dietz

Research output: Contribution to journalReview article

23 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)995-1003
Number of pages9
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume123
Issue number6
DOIs
Publication statusPublished - 1 May 2016

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Pelvic Floor
Anal Canal
Randomized Controlled Trials
Parturition
Confidence Intervals
Numbers Needed To Treat
Wounds and Injuries
Equipment and Supplies
Postpartum Period
Second Labor Stage
Pregnancy
Third Pregnancy Trimester
Tears
Obstetrics
Ultrasonography
Outcome Assessment (Health Care)

Keywords

  • Anal sphincter tear
  • Epi-No
  • levator avulsion
  • pelvic floor trauma
  • perineal trauma

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Does the Epi-No® birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial. / Kamisan @ Atan, Ixora; Shek, K. L.; Langer, S.; Guzman Rojas, R.; Caudwell-Hall, J.; Daly, J. O.; Dietz, H. P.

In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 123, No. 6, 01.05.2016, p. 995-1003.

Research output: Contribution to journalReview article

@article{7e5f3d0c939c4a5a93400d520e869b06,
title = "Does the Epi-No{\circledR} 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{\circledR} 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{\circledR} 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{\circledR} 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{\circledR} device on intrapartum pelvic floor rauma.",
keywords = "Anal sphincter tear, Epi-No, levator avulsion, pelvic floor trauma, perineal trauma",
author = "{Kamisan @ Atan}, Ixora and Shek, {K. L.} and S. Langer and {Guzman Rojas}, R. and J. Caudwell-Hall and Daly, {J. O.} and Dietz, {H. P.}",
year = "2016",
month = "5",
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TY - JOUR

T1 - Does the Epi-No® birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial

AU - Kamisan @ Atan, Ixora

AU - Shek, K. L.

AU - Langer, S.

AU - Guzman Rojas, R.

AU - Caudwell-Hall, J.

AU - Daly, J. O.

AU - Dietz, H. P.

PY - 2016/5/1

Y1 - 2016/5/1

N2 - 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.

AB - 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.

KW - Anal sphincter tear

KW - Epi-No

KW - levator avulsion

KW - pelvic floor trauma

KW - perineal trauma

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U2 - 10.1111/1471-0528.13924

DO - 10.1111/1471-0528.13924

M3 - Review article

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JO - BJOG: An International Journal of Obstetrics and Gynaecology

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