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BJOG. 2016 May;123(6):995-1003. doi: 10.1111/1471-0528.13924. Epub 2016 Feb 29.

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

Author information

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.

KEYWORDS:

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

PMID:
26924418
DOI:
10.1111/1471-0528.13924
[Indexed for MEDLINE]
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