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 â 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 â device from 37 weeks of gestation until delivery.

Can pelvic floor trauma be predicted antenatally?

“…Another issue of concern is that, to increase the power of the index project, some of the datasets used were collected as part of a prospective interventional study examining the effect of antepartum use of a birth device on pelvic floor trauma. Although use of this device could have potentially confounded the results, this seems unlikely, as the intervention was shown to have no effect on the incidence of levator trauma . A repeat analysis after excluding women in the intervention arm of the EpiNo Study yielded near‐identical results.…”

“…The intervention arm of this trial was included in the analysis, as the intervention (i.e. use of the Epi‐No birth trainer) was shown to have no effect on levator avulsion, irreversible overdistention (microtrauma), perineal tears or anal sphincter injuries . Power calculations were not undertaken, as this is a secondary analysis of the two trials for which sample size had been determined independently.…”

“…Levator injury has a quoted incidence of 10–36% . It has been shown to be a strong risk factor for pelvic organ prolapse (POP) .…”

Systematic review of pelvic floor interventions during pregnancy

“…However, an intact perineum is considered a minor outcome without clinical relevance. The two other studies compared the incidence of puborectalis avulsion and hiatal overdistension using perineal ultrasonography, and failed to show any benefit for the use of EPI‐NO. One study investigated the risk of anal sphincter trauma and found no difference for this outcome measure either.…”

Authors' reply re: Does the Epi‐No birth trainer prevent vaginal birth‐related pelvic floor trauma? A multicenter prospective randomised controlled trial

“…Since she was not sent the 2016 Epi-No review for peer review, this article did not undergo appropriate scientific review, and as a result should never have appeared in a scientific journal. 2 The review is premised on the incorrect assumption that episiotomy is not obsolete. 3 Luckily people have more evidence-based sources of information than BJOG.…”