1
Antepartum use of Epi-No Birth Trainer for preventing perineal trauma: systematic
2
review
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Luiz Gustavo Oliveira Brito, MD, MsC, PhD*, Cristine Homsi Jorge Ferreira, PT, PhD**,
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Geraldo Duarte, MD, MsC, PhD*, Antonio Alberto Nogueira, MD, MsC, PhD*, Alessandra
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Cristina Marcolin, MD, MsC, PhD*
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*Department of Gynecology and Obstetrics, Ribeirão Preto School of Medicine, University
7
of Sao Paulo, Ribeirao Preto, Brazil.
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**Physical Therapy Course, Ribeirão Preto School of Medicine, University of Sao Paulo,
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Ribeirao Preto, Brazil.
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Corresponding author:
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Luiz Gustavo Oliveira Brito
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Avenida Bandeirantes, 3900 – 8th floor – Monte Alegre – Ribeirão Preto – SP – Brazil
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Zip code 14049-900 – E-mail:
[email protected]
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Telephone: +55(16)-3602-2804 / Fax: +55(16)-3633-0946
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Partially presented at the American Urogynecological Society (AUGS) joint meeting with the
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International Urogynecological Association (IUGA) held in Washington DC, 22-27 July
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2014
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Authors participation:
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LG Brito: Project development, Data Collection/Analysis, Manuscript writing/editing;
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AC Marcolin: Project development, Data Collection, manuscript editing
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CH Ferreira: Manuscript writing/editing
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G Duarte and AA Nogueira: Project development,manuscript editing
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Abstract – 242 words; Main text – 2,051 words
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Conflict of interest: The authors declare that they have no conflict of interest.
25 26 27 1
28
Abstract
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Introduction and hypothesis: This systematic review aimed to assess if Epi-No birth trainer
30
used during antepartum could prevent perineal trauma in nulliparous women.
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Methods: We searched CENTRAL, MEDLINE, EMBASE, Scielo and Conference abstracts,
32
looking for randomized controlled studies (RCT). High heterogeneity (i2 > 50%) was
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corrected at random models. All studies were analyzed according to their quality and risk of
34
bias. Nulliparous women or women whose previous pregnancy ended before 21 weeks of
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gestational age were included and the main outcome measures were: episiotomy rates,
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perineal tears, severe (3rd/4th) perineal tears and intact perineum.
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Results: Five studies were included (1,369 participants) for systematic review and two of
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them (932 participants) were eligible for metaanalysis. Epi-No did not reduce episiotomy
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rates (RR 0.92 [95%CI 0.75-1.13], n=710 , p=.44; 2 studies; fixed model) and second stage of
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labor (MD -12.50 [95%CI -29.62,-4.62], n=162, p=.54; 1 study; fixed model), as well as did
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not increase intact perineum (RR 1.15 [95% CI 0.81-1.64], n=705 ,p=.43; 2 studies; random
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model). It was not seen an influence from Epi-No to reduce all perineal tears (RR 0.99
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[95%CI 0.84-1.17], n=705, p=.93, 2 studies; fixed model) or severe (3rd/4th) perineal tears
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(RR 1.31 [95%CI 0.72-2.37], n=705, p=.38, 2 studies; fixed model). Mean birthweight of the
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Epi-No group were higher than the control group in both studies, with no statistical
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significance.
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Conclusion: Epi-No birth trainer is a device that did not reduce episiotomy rates with no
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influence at reducing perineal tears.
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Keywords: perineal trauma; systematic review; Epi-No; episiotomy
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Brief summary: Epi-No did not reduce the second stage of labor and had no influence at
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reducing perineal tears.
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2
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Introduction
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Perineal trauma is a traumatic condition associated with high maternal morbidity,
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leading to acute and chronic disabilities [1]. Most important ones are fecal incontinence,
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posterior prolapse, urinary incontinence, chronic pelvic pain [2]. It is a consequence of
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diverse risk factors (parity, birthweight, prolonged second stage of labor, episiotomy) [3,4]
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acting isolated or combined, and should be prevented by interventions applied before or
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during childbirth. Also, there are social and psychological impairments, and stigmatization
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of its effects for women worldwide [5].
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Many interventions have been proposed to decrease the risk of developing perineal
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tears, such as perineal massage [6], and warm compresses during second stage of labor [7].
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However, other techniques are being considered for usage during antepartum period; a device
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entitled Epi-No birth trainer (Starnerg Medical, Tecsana GMBH, Muenchen, Germany) was
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created to be used before labor by a German physician [8].
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Epi-No is a vaginal dilator It has been indicated for pregnant women with the aim of
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reducing perineal trauma. Few studies have been performed to analyze its efficacy to reduce
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perineal tears and episiotomy rates, decrease cesarean deliveries and increase vaginal
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deliveries. Up to our knowledge, there are no systematic reviews regarding this device and
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this was the proposal for this study.
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Materials and methods
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Study register and search strategy
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The protocol used in the present review was registered in the PROSPERO
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International Prospective Register of Systematic Reviews
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(http://www.crd.york.ac.uk/NIHR_PROSPERO/) under number CRD42014008677. No
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inscription was necessary in our Institutional Review Board. This review was conducted in
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accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses
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(PRISMA) [9].
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There were no restrictions based on language or publication status. Two authors
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(L.G.O.B, A.C.M) performed the search and its strategy was restricted and included the
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following words: Epi-No OR “birth trainer” OR “vaginal dilator”. We searched
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the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Scielo
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databases from inception by July 15th 2014. Conference abstracts (International 3
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Urogynecological Association, American Urogynecological Society and International
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Continence Society meetings) were also searched from 2007 by July 15th 2014. We also used
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the “related citations in PubMed” function to expand our search criteria. All data which was
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not possible to find from the manuscripts was searched directly with the authors by e-mail.
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Study selection
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We included studies with primiparous women or women whose previous pregnancy
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has ended before 21 weeks of gestational age and that have used antepartum Epi-No birth
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trainer system versus any other form of medical treatment or no treatment. We restricted
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eligibility to both prospective, randomized and non-randomized studies. Twelve studies were
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selected and all were reviewed independently by two review authors (L.G.O.B, A.C.M). The
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PRISMA flow chart (Figure 1) explains the steps of the selected studies and reasons for
97
excluding some of them.
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Six studies remained in the final analysis; three were randomized studies [12,15-16] and two of them were from the same research [15-16]. Thus, we used the updated data of this
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long RCT from Australia [16] and five studies [8,12-14,16] could be eligible for systematic
101
review: two [12,16] randomized controlled studies, one [14] prospective non-randomized
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study and two [8,13] prospective case studies with retrospective matched-controls. Potentially
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eligible records had their texts fully evaluated by the same review authors. As there were no
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doubts about inclusion, we did not request a third author to make conferences. A table was
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created to gather all selected studies (Table 1) with their characteristics.
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Outcomes of interest
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Primary outcomes were: episiotomy rates, perineal tears, severe (3rd/4th) perineal tears
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and intact perineum. Secondary outcomes were: spontaneous and operative vaginal
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deliveries, levator avulsion trauma, Apgar score > 7 (dichotomous variables); birthweight,
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duration of second stage of labor (continuous variables). Not all variables were found in all
111
studies. Only two outcomes could be analyzed in all five studies: episiotomy rates and intact
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perineum.
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Risk of bias in individual studies
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The risk of bias was independently assessed by two authors (L.G.O.B, C.H.J.F) using
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the Cochrane criteria [10]: selection bias (random sequence generation and allocation
116
concealment), performance bias (blinding of participants and personnel), attrition bias
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(incomplete outcome data), reporting bias (selective reporting), and detection bias (blinding
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of outcome assessment). 4
119 120 121
Statistical analysis We used Review Manager version 5.3 (Cochrane Collaboration, Oxford, UK) to
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perform a metaanalysis of the randomized controlled studies. For continuous variables, we
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calculated the mean difference (MD) and standard deviation (SD); for outcomes reported as
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dichotomous data, we calculated the risk ratio (RR). We presented the 95% confidence
125
intervals (CI) for all outcomes. Heterogeneity was calculated by the I2 measurement; a value
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greater than 50% was taken to indicate substantial heterogeneity and a random model was
127
used to establish a result [12]. Funnel plot was not performed due to the small number of
128
studies, so the publication bias was not assessed.
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Results
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Five experimental studies comprised 1,369 women and were published from 2001 to
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2014; two of them were performed in Australia and four informed sponsoring of the devices.
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The study with the longest duration (7 years) was the recent one [16] with 660 women. The
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majority of the patients had similar baseline characteristics and the conclusion from two
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studies was that Epi-No decreased the rate of episiotomies in primiparous women [8,13] and
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increased the likelihood of having an intact perineum [12,14], except for the most recent
136
study [16].
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Nine hundred thirty-two patients were assessed in the two RCTs [12,16] , and within
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these studies, Epi-No did not reduce episiotomy rates (RR 0.92 [95%CI 0.75-1.13], p=.044,
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n=710, 2 studies; fixed model – Figure 2) and second stage of labor (MD -12.50 [95%CI -
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29.62,4.62], p=.54, n=162, 1 study; fixed model), as well as did not increase intact perineum
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(RR 1.15 [95%CI 0.81-1.64], p=.43, n=705, 2 studies, random model – Figure 3). Moreover,
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it was not seen an influence from Epi-No to reduce all perineal tears (RR 0.99 [95%CI 0.84-
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1.17], p=.55, n=705, 2 studies, fixed model – Figure 4) and severe (3rd/4th) perineal tears (RR
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1.31 [95%CI 0.72-2.37], p=.84, n=705, 2 studies, fixed model – Figure 5).
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With regard to delivery, Epi-No did not show any influence by increasing
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spontaneous vaginal delivery (RR 0.99 [95% CI 0.88-1.11]; p=.39, n=932, fixed model –
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Figure 6) or reducing operative vaginal delivery (RR 1.05 [95%CI 0.81-1.35]; p=.61, n=932,
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fixed model - Figure 7). Neonatal outcomes were not influenced as well; it was not shown
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higher fifth-minute Apgar scores by the use of Epi-No (RR 1.00 [95% CI 0.96-1.04]; p=.86,
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n=822, fixed model – Figure 8). However, mean birthweight groups were higher in Epi-No 5
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than control groups (MD 50.26 [95% CI -10.24,110.76]; p=.56, n=822, fixed model – Figure
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9). Dietz et al.[16] were the only study that addressed levator avulsion trauma and no
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differences were found between the groups.
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Risk of bias was also assessed in all selected studies (Figure 10), and only one study
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met almost all criteria for low-risk bias [16]. This study, as well as the others, received a
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moderate to high-risk score for not blinding the patients because it was not possible to blind
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the Epi-No group. However, the researchers were blinded at all moments of the research, as
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well as Ruckaberhle study [12]. Moreover, moderate to high heterogeneity was present in
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almost 40% of all analyses.
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Discussion
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The use of antepartum Epi-No birth trainer has completed 15 years and few studies
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have been performed to know its effectiveness to decrease perineal trauma. Our systematic
164
review has shown that Epi-No did not have an influence by decreasing episiotomy rates and
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increasing the percentage of intact perineum; moreover, it did not show any association
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regarding perineal tears. Despite the small number of randomized controlled studies in this
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review, the quality of the studies is high, especially when Dietz et al. [16] is included in the
168
analysis.
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The purpose of using the Epi-No device would be to stretch the vaginal wall until its
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maximum diameter; once doing this repeatedly, it would facilitate perineal distension during
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birth labor. This is inversely similar, but not equal, to the principle of perineal massage.
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However, information about the mean of perineal distension diameter after balloon inflation
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was not obtained in all studies. This is an information that is interesting to obtain in order to
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compare its value with the risk of perineal trauma. We already know that perineal
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distensibility of Epi-No differs according to parity (19.3 cm primiparous group vs. 20.7 cm
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multiparous group; p < .001) [17] and does not differ according to the number of fetuses
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(16.51 – twin group vs 16.13 singleton group; p=.50) [18].
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Moreover, we also know that, the bigger the perineal distensibility, the smaller is the
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pain score from visual analogic index [18]. But we do not know if we have an ideal cutoff
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point of perineal distension that could be related to a decrease in pain sensation during labor.
6
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This could be an objective of a future study addressing pain reduction in labor with a group
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using Epi-No and a control group.
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No studies could demonstrate that Epi-No reduces the risk of severe perineal trauma
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and the RCT conducted by Dietz [16] did not show any difference regarding levator avulsion
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trauma or significant microtrauma between groups. It is known that the risk of a 3rd/4th
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perineal tear is increased five-fold in women who had a previous one in their first delivery
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[19]. In fact, the authors have found a marginal association with Epi-No for significant
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sphincter defects, but this finding may be spurious according to the authors. Most of the
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follow-up period of these studies were 5-6 months after the delivery, so long-term
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consequences, such as fecal incontinence or pelvic prolapse were not analyzed.
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It is important to remember that one variable strictly related to perineal trauma is
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birthweight. We know that values higher than 4000 grams are associated with perineal trauma
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[20] and Epi-No’s group mean birthweight was higher than the control group. This might
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have influenced at the incidence of perineal trauma. A secondary analysis would be
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interesting if this variable was homogenized between the groups and the outcomes were
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recalculated.
197
The application of episiotomy is mainly associated with perineal tears and this was
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already addressed in several studies [20,21], despite having some few studies [1] that have
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shown a protective effect instead of a risk factor. The exact moment of performing it or not is
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usually indicated during the fetal detachment at the pelvic period. If the vaginal canal and
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introitus stretches sufficiently to allow the fetus to go out, no perineal trauma is seen. These
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studies were addressing to analyze if Epi-No reduced the number of episiotomy rates. We
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could suggest that a possible trend for this effect exists; however, we cannot exclude
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publication bias in this review due to the number of studies included to prepare a funnel plot.
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All studies had donations from the industry that produces the device; however, no conflict of
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interest was reported.
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The strengths of our systematic review are that, up to our knowledge, we are the first
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ones reporting the pooled results of the effect from this antepartum vaginal dilator and that
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we have included two randomized controlled with few biases and consistent results.
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Randomization was described adequately in both studies, and researchers were blinded for
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the groups. We decided not to provide a funnel plot with all studies due to the low number of
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publications. 7
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However, several limitations were noticed when analyzing these studies. One of them
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was related about how were the conditions of the labor. We could not be sure if all deliveries
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were conducted by professionals who used other techniques (eg. hands-on, warm
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compresses) combined with the prior use of Epi-No, because labor was not influenced by the
217
studies. Also, the duration of Epi-No use varied among the studies, and the compliance by
218
using it was not assessed in all of them, as well as the experience of the
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midwives/obstetricians. Finally, high heterogeneity was found in almost 40% of the variables
220
analyzed; in systematic reviews, we usually find this percentage around 25% [11].
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Further randomized controlled trials are needed for this device; a future study with a
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control group that performed a standard treatment would also be important, such as perineal
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massage, and not just orientation for terms of comparison of another treatment, as well as
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studies that merge different approaches (perineal massage plus Epi-No device versus no
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treatment or gold-standard control treatment) to better place the use of Epi-No as a device for
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reducing perineal tears and episiotomy rates.
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Funding
228 229 230 231
The authors declare that no funding was provided to perform this systematic review. Acknowledgments We would like to thank Nieck Pouwels for helping us with the German translation of Hillebrenner data.
232 233 234
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2. Borrelo-France D, Burgio KL, Richter HE et al (2006) Fecal and urinary incontinence
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5. Krause HG, Natukunda H, Singasi I, Hicks SS, Goh JT (2014) Treatment-seeking
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tears, and obtetric fistula in western Uganda. Int Urogynecol J DOI: 10.1007/s00192-
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014-2442-6.
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7. Assheim V, Nilsen AB, Lukasse M, Reinar LM (2011) Perineal technques during the
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8. Hillebrenner J, Wagenpfeil S, Schuchardt R, Schelling M, Schneider KT (2001) Initial
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9. Moher C, Liberati A, Tetzlaff J, Altman DG (2009) Preferred reporting items for
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12. Ruckhaberle E, Jundt K, Bauerle M et al (2009) Prospective randomized multicenter
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13. Kok J, Tan KH, Koh S, et al (2004) Antenatal use of a novel vaginal birth training
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14. Kovacs GT, Health P, Healther C (2004) First Australian trial of the birth-training
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15. Shek KL, Chantarasorn V, Langer S, Phipps H, Dietz HP (2011) Does the Epi-No
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291 292 293 294 295 296 297 10
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Table 1 – Baseline characteristics of the prospective studies Hillebrenner
Kok 2004
2001 Country
Germany
Singapore
Kovacs
Ruckaberhle
2004
2009
Australia
United
Dietz 2014
Australia
Kingdom Sponsoring
Not informed
JDH Medical
Tecsana
Tecsana
Tecsana
Systems
donated
donated Epi-
donated Epi-
Epi-No
No devices
No devices in
devices
the first part of work in 201116; no sponsoring reported in the abstract
Conflict of
Not informed
Not informed
interests
Not
Not
informed
informed
Informed
IRB approval
Not informed
Not informed
Yes
Yes
Yes
Signed
Not informed
Yes
Yes
Yes
Yes
Prospective
Prospective
Prospective
Prospective
Prospective
pilot cohort
study with
non-
randomized
randomized
study with
retrospective
randomized
study
study
retrospective
controls
study
consent form Study design
controls Recruiting
May 1998-
July-December
Not
February
July 2007-
period
August 1999
2002
informed
2000-2002
March 2014
Inclusion
Primiparous
Primiparous
Primiparou
Primiparous
Primiparous
criteria
with single
with single
s with
with single
with single
pregnancy or
pregnancy > 37 single
pregnancy
pregnancies 11
secundiparou
weeks
s with a
pregnancy
or
> 37 weeks
secundiparou
previous
s with
abortion > 38
previous
weeks of GA
abortion
Exclusion
Multiparity,
GA < 37
Not
Multiparity,
criteria
GA less than
weeks,
informed
Multiple
38 weeks,
multiparity,
pregnancy,
latex allergy,
multiple
Water birth,
present
pregnancy,
pelvic
vaginal
previous
anomalies,
infections,
vaginal/perinea
Multiple
any major
l surgery, EFW
sclerosis,
risk factor
> 4000 g
placenta
related to c-
previa,
section
Macrossomi
Not informed
c fetuses, paraplegia, Number of
2; 50
2; 31 cases/60
2; 48 cases
2; 272
2; 660
groups and
cases/50
controls
/248
women; 135
women, 335
participants
matched-
controls
cases and
cases and
137 controls
325controls
controls Informed
Unclear
No
Yes
Yes
Yes
Description
10 min-
15 min-
15 min-
15 min-
20 min-
of Epi-No
exercise with
exercise with
exercise
exercise
exercise with
group
Epi-No per
Epi-No per day
with Epi-
with Epi-No
Epi-No per
day till
till delivery.
No per day
per day till
day till
delivery.
They have
till
delivery.
delivery.
Received a
documented
delivery.
Phone after
Received a
training
using in a log
Information
4 days to
training
drop-outs
12
Age
before
diary to access
starting.
Not informed
enhance
before
the end of
compliance.
starting.
surgery
Received a
Follow-up
training
after 3
before
months
starting.
delivery.
31.3(±4.2)
28.9(±5.8)
Not
Not
29.4(±4.7)
informed
informed
31.1 (±3.1)
+ leaflet.
Not informed
BMI
Similar
Not informed
Not informed
Unclear
Unclear
Yes
Yes
Yes
Mean
Not
2.1 weeks
Not
15.1 days
Not informed
duration of
informed.
(±1.2)
informed
(±7.7)
To analyze
To study the
To assess if
To assess if
To assess if
effectiveness
use, safety and
Epi-No
Epi-No
Epi-No could
of Epi-No in
effectiveness
decreases
influences
reduce
avoiding
of Epi-No in
instrumenta
the rates of
perineal
episiotomies
primiparous
l delivery,
episiotomies
trauma
and to
women
episiotomy
and intact
improve fetal
rates,
perineum.
outcomes.
duration of
baseline characteristic s between groups
Epi-No use Objectives
second stage, perineal tears
13
Outcomes
Episiotomy,
Episiotomy,
Mode of
Episiotomy,
Levator
perineal
perineal tears,
delivery
intact
trauma
tears,
pain after labor
perineum,
avulsion,
neonatal
second stage
episiotomy,
APGAR
instrumental
score,
1st /5th min labor length, Apgar use of
average time
scores
analgesics
length of 2nd
of training,
2nd stage
and vaginal
stage, Apgar
labor
duration
infections
score,
Perineum
duration,
delivery,
birthweight
analgesia Intention to
No
No
Unclear
Yes
Yes
Birth training
Epi-No
Epi-No
Epi-No
Epi-No
with Epi-No
decreased the
increased
increased the decreased
decreased the
rate of
the number
likelihood of
incidence of
rate of
episiotomies in
of intact
having an
pelvic floor
episiotomies
term
perineum
intact
muscle injury
in
primiparous
and showed
perineum
in a non-
primiparous
and the degree
a trend to
and showed
significant
significantly
of perineal
decrease
a non-
difference
tear.
perineal
statistical
tears
trend to
treat analysis Conclusions
decrease episiotomy rates. 299
Notes: EFW = estimated fetal weight/ GA = gestational age; SD in parenthesis
300
Figure 1. PRISMA flowchart for selection of studies
301 302
14
303 304
PRISMA 2009 Flow Diagram
305 306
Identification
307 308 309
124 records identified through database searching n =46 PubMed 7 Additional records identified through other sources (AUGS/IUGA/ICS)
n =68 Embase n= 9 Cochrane n=1 Scielo
310 311
Records after duplicates removed (n =36 )
Screening
312 313 314
Records screened (n =95 )
Records excluded (n =83 irrelevant topics )
Full-text articles assessed for eligibility (n =12 )
Full-text articles excluded, with reasons (n =3 absence of relation between title and abstract; 3 noncomparative design; 1 study was an old version of an updated one)
315
Eligibility
316 317 318 319 320
Studies included in qualitative synthesis (n =5 )
Included
321 322 323 324 325 326
15
327
328 329
Figure 2. Forest plot for the episiotomy rates.
330 331
Figure 3. Forest plot for intact perineum.
332 333
Figure 4. Forest plot for all perineal tears.
334 335
Figure 5. Forest plot for 3rd/4th degree perineal tears.
336 16
337
Figure 6. Forest plot for spontaneous vaginal delivery.
338 339
Figure 7. Forest plot for operative vaginal delivery.
340 341
Figure 8. Forest plot for 5th minute Apgar index >7.
342 343
Figure 9. Forest plot for mean birthweight.
17
344 345
Figure 10. Risk of bias of individual studies.
346
Note: Green – low risk; Yellow – unclear risk; Red – high risk
347
18
