Does the Epi-No-(R) birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial
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Atan, I. Kamisan
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Does the Epi-No-(R) birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial
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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.
Keywords Anal sphincter tear, Epi-No , levator avulsion, pelvic
floor trauma, perineal trauma.
Patrocinador
Australian Women & Children's Research Foundation (OZWAC) ;
Nepean Medical Research Foundation (NMRF)
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Artículo de publicación ISI
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BJOG 2016;123:995–1003
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