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European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100

Contents lists available at ScienceDirect

European Journal of Obstetrics & Gynecology and


Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Review article

Risk factors for severe perineal trauma during childbirth: An updated


meta-analysis
Vasilios Pergialiotisa,b,* , Ioannis Bellosa , Maria Fanakia , Nikolaos Vrachnisb ,
Stergios K. Doumouchtsisa,c,d
a
Laboratory of Experimental Surgery and Surgical Research N.S Christeas, National and Kapodistrian University of Athens, Greece
b
Second Department of Obstetrics and Gynecology, Attikon University Hospital, National and Kapodistrian University of Athens, Greece
c
Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, London, United Kingdom
d
St George's University of London, London, United Kingdom

A R T I C L E I N F O A B S T R A C T

Article history: Several studies have investigated the importance of maternal, fetal factors and intrapartum character-
Received 6 January 2020 istics in predicting severe perineal lacerations. The purpose of the present systematic review is to
Received in revised form 11 February 2020 accumulate current evidence and provide estimated effect sizes for the various risk factors described. We
Accepted 13 February 2020
reviewed Medline, Scopus, Clinicaltrials.gov, EMBASE, Cochrane Central Register of Controlled Trials
CENTRAL and Google Scholar for published studies in the field for observational studies as well as
Keywords: randomized controlled trials. Two researchers independently assessed the included studies and
Perineal trauma
documented outcomes. Data extraction was performed using a modified data form that was based in
Perineal lacerations
Obstetric trauma
Cochrane`s data collection form for intervention reviews for RCTs and non-RCTs. Forty-three articles were
OASIS selected for inclusion in the present systematic review. The analyzed population reached 716,031
Sphincter trauma parturient of whom 22,280 (3,1%) sustained third- and fourth-degree perineal lacerations. Several risk
Meta-analysis factors were identified. Instrumental delivery [RR 3.38 (2.21, 5.18)], midline episiotomy [RR 2.88 (1.79,
4.65)] and a persistent occiput posterior position [RR 2.73 (2.08, 3.58)] were associated with the higher
risk of developing severe perineal lacerations. Mediolateral episiotomy did not increase, but was also not
protective against perineal lacerations [RR 1.55 (0.95, 2.53)]. Several factors contribute to the
development of severe perineal lacerations. The present meta-analysis presents accumulated data that
may help physicians estimate risks and provide appropriate patient counseling.
© 2020 Elsevier B.V. All rights reserved.

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Materials and methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Study design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Study selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Selection of outcomes and data extraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Assessment of risk of bias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Primary statistical analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Secondary statistical analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Meta-regression analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Sensitivity analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Prediction intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Outcomes that were not included in the quantitative synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

* Corresponding author at: 6, Danaidon str., Halandri, 15232, Greece.


E-mail address: pergialiotis@yahoo.com (V. Pergialiotis).

https://doi.org/10.1016/j.ejogrb.2020.02.025
0301-2115/© 2020 Elsevier B.V. All rights reserved.
V. Pergialiotis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100 95

Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98


Strengths and limitations of the study . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Implications for current clinical practice and future research in the field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Contribution to authorship . . . . . . . . . . . . . . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Ethics statement . . . . . . . . . . . . . . . . . . . . . . . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............. .......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Introduction Central Register of Controlled Trials CENTRAL (1999–2019) and


Google Scholar (2004–2019) databases in our primary search along
The unprecedented rise in cesarean section rates renders it a with the reference lists of electronically retrieved full-text papers
global epidemic and the latest Lancet report suggests that the rates of (snowballing). The date of last search was set at August 30th 2019.
this procedure risen the past 15 years reaching a steep 21 % [1]. The The search strategy included the words “perineal lacerations;
World Health Organization (WHO) statement on cesarean section perineal trauma; perineal tear; childbirth trauma; birth trauma;
rates supports that cesarean section rates above 10–15 % are obstetric trauma; obstetric anal sphincter injury; OASIS; third degree
unjustified, regardless the region and population they refer to [2]. At tear; fourth degree tear” and is in accordance to that performed in a
2018 FIGO issued a position paper that aims to support professional previous article [9]. The PRISMA flow diagram presented in Fig. 1
organizations, women`s groups and other stakeholders to support summarizes the search process for article retrieval.
normal labor [3]. The most important reason behind these state-
ments is the increased morbidity that accompanies cesarean Study selection
sections. Despite the lower rates of maternal and neonatal morbidity
that seem to be associated with normal labor, perineal trauma Two authors (V.P. and M.F.) were responsible for the electronic
remains still common at childbirth, affecting 53–79 % of women [4]. search and study selection process. Language, country or date
Perineal lacerations are classified in four distinct degrees, with third restrictions were avoided to minimize the possibility of potential
and fourth degree being usually referred as severe forms as they are article losses. The process for article retrieval was divided in three
accompanied by increased rates of immediate and long term consecutive stages. During the first stage, and following dedupli-
morbidity that significantly affects women`s quality of life (QoL) [5]. cation of retrieved studies, we screened the titles and abstracts to
Despite these critical issues, to date, significant discrepancies exist evaluate the potential eligibility of articles. Those that were
in an international level, concerning the optimal preventive manage- presumed to meet the criteria for selection were retrieved in full
ment of severe perineal lacerations, often referred to as OASIS text, read thoroughly and snow-balling of references was also
(obstetric anal sphincter injury) [6]. The incidence of OASIS varies conducted to evaluate the eligibility of articles that could have been
between 3 and 7 % of normal deliveries and according to the findings of potentially missed in our electronic search (step 2). In the final stage,
recent cohort study that was based in 75,000 deliveries, current all observational (both prospective and retrospective) studies as well
preventive strategies have reached a plateau; therefore, further as randomized controlled trials (including quasi-randomized trials)
decline of the incidence of sphincter injurycannot be anticipated using that reported outcomes relevant to the development of severe
existing measures. Identification of risk factors that increase the odds perineal lacerations among women with and without risk factors
of developing OASIS is a matter of primary importance and estimation included in our previous systematic review were considered as
of the actual effect size may help future studies combine this evidence eligible for inclusion. Conference proceedings and abstracts were
to enhance the diagnostic accuracy of algorithms that can target also considered to be eligible, provided that the outcome of interest
women at risk of developing OASIS. In a previous meta-analysis that was available within their context. When studies with duplicate or
included 22 studies, Pergialiotis et al. observed that various factors overlapping referral, populations were retrieved the ones with the
increase the risk of developing severe perineal lacerations, including most complete dataset were included in the meta-analysis. Animal
increased birthweight, use of episiotomy and labor augmentation [7]. studies, case reports, case series and review articles were excluded
Since then, several articles were published in this field, rendering from the present meta-analysis. When discrepancies arose between
necessary an update. In the present systematic review and meta- the two authors concerning article eligibility, assessment of risk of
analysis, we updated our research, adding more evidence in the field bias and selection of statistical analysis they were resolved by the
and also enhanced our analysis in order to evaluate the contribution of consensus of all authors.
potential confounders in our analysis.
Selection of outcomes and data extraction
Materials and methods
Outcomes retrieved in the present meta-analysis were based in
Study design the findings of the previous meta-analysis published in this field
[7]. Data extraction was performed using a modified data form that
The present meta-analysis was designed according to the was based in Cochrane`s data collection form for intervention
Preferred Reporting Items for Systematic Reviews and Meta- reviews for RCTs and non-RCTs [10].
Analyses (PRISMA) guidelines and has been registered in
PROSPERO (CRD42019139612) [8]. Eligibility criteria were pre- Assessment of risk of bias
determined by the authors.
The methodological quality of included studies was indepen-
Sources dently assessed by two authors (M.F. and N.V.) using the
Newcastle-Ottawa Scale (NOS), which evaluates the selection of
We used the Medline (1966–2019), Scopus (2004–2019), the study groups, the comparability of the groups and the
Clinicaltrials.gov (2008–2019), EMBASE (1980–2019), Cochrane ascertainment of the exposure or outcome of interest [11].
96 V. Pergialiotis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100

Fig. 1. PRISMA search plot diagram.

Primary statistical analysis North America, Europe and Australia, 2: rest of the world) and
parturient care (midwife vs physician). Following retrieval of
Meta-analysis of risk ratios (RR) and mean differences (MD) articles, we observed that meta-regression analysis for parturient
was performed with the RevMan 5.3 software (Copenhagen: The care was not possible due to insufficient data that could not
Nordic Cochrane Centre, The Cochrane Collaboration, 2011). preclude the possibility of erroneous interpretation of the type of
Confidence intervals were set at 95 %. The DerSimonian–Laird care administered. Similarly, meta-regression analysis for study
random effect model was selected to calculate the reported RRs type and origin of study were of no use as the vast majority of
as well as 95 % confidence intervals (CI), due to the significant published articles were retrospective and research was almost
heterogeneity of the methodological characteristics of included unanimously published from researchers from countries of the
studies that was expected to arise, given the results of the North America, European and Australia.
previous meta-analysis [7,12]. Publication bias was evaluated for
the sum of studies included in our primary analysis using funnel Sensitivity analysis
plots constructed with the Review manager software and the
Begg and Mazumdar rank correlation as well as the Egger`s The potential impact of individual studies on the overall
regression intercept were calculated using the regtest function in outcome of the primary analysis was investigated with leave-one-
R [13]. out analysis; one study was sequentially omitted at a time to
evaluate its effect in the outcome of the meta-analysis using the
Secondary statistical analysis Open Meta-Analyst software.

Meta-regression analysis, sensitivity analysis and trial sequen- Prediction intervals


tial analysis were performed to control for potential confounders
that could affect the results of the primary analysis. Furthermore, prediction intervals were calculated as they
provide an estimation of the effects to be expected by future
Meta-regression analysis studies in the field. More specifically, prediction intervals take into
account the inter-study variation of the results and express the
Univariate meta-regression was performed with Open Meta- existing heterogeneity at the same scale as the examined outcome.
Analyst statistical software [14]. We sought to investigate the As proposed by IntHout et al. [15], prediction intervals are
influence of the year of publication, study type (prospe ctive vs calculated in the logarithmic scale as logOR  t  SDPI , where OR
retrospective), patient number (using a cut-off of 1000 patients per represents the meta-analytic odds ratio, t the two-sided critical t-
group of patients), origin of the study (per continent assigned as 0: value and SDPI the standard deviation of the prediction interval. It
V. Pergialiotis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100 97

Table 1
Results of the quantitative analysis.

Assessed variable Number of studies Parturient number (severe lacerations/controls) Effect estimate (95 % CI)
Asian ethnicity 11 146,584 (6,950/139,634) RR 1.87 (1.46, 2.39)
Primiparity 29 613,989 (13,253/600,736) RR 1.59 (1.45, 1.75)
Duration of second stage 7 43,095 (1,148/41,947) MD 28.46 (22.44, 34.48)
Induction of labour 15 501,863 (9,924/491,939) RR 1.05 (0.97, 1.15)
Augmentation of labour 13 76,467 (3,536/72,931) RR 1.46 (1.32, 1.62)
Epidural 23 294,373 (8,047/286,326) RR 1.21 (1.08, 1.36)
Occiput posterior 12 369,427 (8,013/361,414) RR 2.73 (2.08, 3.58)
Mediolateral episiotomy 12 564,247 (12,043/552,204) RR 1.55 (0.95, 2.53)
Midline episiotomy 11 475,545 (13,531/462,014) RR 2.88 (1.79, 4.65)
Any type of episiotomy 29 659,640 (17,080/642,560) RR 1.54 (1.27, 1.86)
Vacuum delivery 17 554,580 (10,890/543,690) RR 2.60 (1.78, 3.79)
Metallic forceps 14 509,398 (13,293/496,105) RR 3.15 (1.91, 5.19)
Instrumental delivery (any) 25 637,150 (16,128/621,022) RR 3.38 (2.21, 5.18)
Neonatal birthweight 13 257,130 (4,960/252,170) MD 163,71 (115.37, 212.06)

RR: risk ratio, MD: mean difference, CI: confidence intervals.


Mean difference in duration of second stage of labor in minutes, mean difference in neonatal birthweight in grams.

should be noted that t is estimated at k-1 degrees of freedom, with severe perineal lacerations but rather tends to increase it, although
k indicating the number of studies included in the meta-analysis. the overall effect does not reach statistical significance (p = .08).
Calculation of SDPI is performed according to the following The mildest increase in the observed risk ratios was that developed
pffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi
formula: SDPI ¼ t 2 þ SE2 , where t 2 represents the existing by the introduction of epidural anesthesia, whereas the biggest risk
heterogeneity and SE the standard error of logOR. Exponentiation was associated, as pathophysiologically expected, with instrumen-
of the limits provides the prediction intervals at the OR scale. tal delivery and particularly metallic forceps delivery. Neonatal
Moreover, the probability that the true effect would be on the other birthweight was also found increased, although it remains unclear
side of the null was estimated using the one-tail cumulative t- whether this is clinically relevant, as the difference was only 160 g.
distribution with k-1 degrees of freedom. Appendix S3 summarizes the results of the publication bias
analysis (funnel plot analysis), the meta-regression analysis and
the leave-one-out meta-analysis. The symmetrical funnel plots
Results indicated that the possibility of publication bias among investi-
gated risk factors was not detected. Similarly, the results of the
Overall, 43 articles were selected for inclusion in the present leave-one-out meta-analysis suggested that no individual study
systematic review [16–58]. The analyzed population reached conferred significantly to the findings of the primary analysis, as
716,031 parturient of whom 22,280 (3,1%) sustained third- and the statistical significance remained unchanged (using a cut-off
fourth-degree perineal lacerations. The methodological assess- value of 95 % for beta. A negative association between the year of
ment of included studies revealed that they were at least adequate publication of each individual study and the risk of developing
(mean Newcastle-Ottawa score for case control studies 6.72  0.89, severe perineal lacerations following the introduction of epidural
Appendix S1 and for cohort studies 7  0.79, Appendix S2). The anesthesia was observed. Similarly, a negative association between
differences of mean values between the two type of studies that the year of publication was observed when performing meta-
were included were not significant (p = .296) after performing non- regression of outcomes concerning the impact of metallic forceps
parametric analysis using the Mann-Whitney U test delivery. On the other hand, a positive association was observed
The meta-analysis of investigated factors revealed that nearly when analyzing the year of publication and use of mediolateral
all of them increased the risk of developing obstetric anal sphincter episiotomy, indicating that in the future the marginally not
injury (3rd or 4th degree perineal lacerations) (Table 1), with the reached statistical significance that was observed in the primary
exception of induction of labor and use of mediolateral episiotomy. analysis could actually change in the future. Concerning the case of
It is worth mentioning, however, that the implemention of persistent occiput posterior position, we observed that publica-
mediolateral episiotomy does not actually prevent the risk of tions that included more than 1000 parturient in each arm severe

Table 2
Results of the prediction intervals analysis.

Outcome Standard error t2 Estimate (95% prediction intervals)


Asian ethnicity 0.16 0.22 2.09 (0.70, 6.30)
Primiparity 0.11 0.28 3.33 (1.09, 10.07)
Labor induction 0.05 0.01 1.06 (0.83, 1.34)
Labor augmentation 0.11 0.03 1.94 (1.23, 3.03)
Epidural anesthesia 0.13 0.31 1.46 (0.45, 4.76)
Birth weight 0.04 0.01 0.32 (0.09, 0.55)
Second stage duration 0.06 0.01 0.36 (0.07, 0.64)
Occiput posterior position 0.15 0.11 2.91 (1.27, 6.69)
Episiotomy 0.31 2.47 2.85 (0.11, 75.9)
Mediolateral episiotomy 0.35 1.38 1.83 (0.12, 27.4)
Median episiotomy 0.32 0.98 4.46 (0.44, 45.6)
Instrumental delivery 0.18 0.74 4.82 (0.79, 29.37)
Vacuum delivery 0.22 0.73 2.71 (0.42, 17.64)
Metallic forceps 0.26 0.84 4.54 (0.57, 36.23)

Estimation of 95 % prediction intervals.


Odds ratio for categorical variables and standardized mean difference for continuous variables.
98 V. Pergialiotis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100

perineal lacerations vs no or minor degree perineal lacerations stratification of parturient as primi- or multiparas was not possible
tended to report a decreased degree of the actual RR of developing as the majority of included studies did not provide data that would
severe perineal lacerations. permit separate analysis based in this information.
The results of the prediction intervals analysis (Table 2) showed
a significant outcome regarding primiparity (OR: 3.33, 95 % PI: Implications for current clinical practice and future research in the
[1.09, 10.07]), birth weight (SMD: 0.32, 95 % PI: [0.09, 0.55]), field
duration of the second stage of labor (SMD: 0.36, 95 % PI: [0.07,
0.64]) and occiput posterior fetal position (OR: 2.91, 95 % PI: [1.27, The importance of identifying and quantifying the effect size of
6.69]), implying that a statistically significant effect is to be the various risk factors that seem to be associated with obstetric
expected by future studies. Prediction intervals of the rest trauma is underlined by a recent study conducted by Jangö et al.
outcomes were wide due to the high between-study heterogeneity. who observed that the introduction of prevention programs
focusing on perineal protection is important [60]. In this study the
Outcomes that were not included in the quantitative synthesis authors underlined the fact that cases with known risk factors,
including episiotomy and forceps delivery, had comparable risk of
Information relevant to the impact of obesity on the risk of developing OASIS. Identification of women that are prone to
developing OASIS remain still scarce in the literature. Differences in develop perineal lacerations, prevention of modifiable factors
body mass index were evaluated in only one study since the (such as excessive weight gain during pregnancy) and appropriate
publication of the previous meta-analysis and they were not patient counseling based in accurate data is important in modern
clinically significant (26.9  3.2 in OASIS vs 26.6  3.4 in no medicine. The results of our meta-analysis are directly applicable
lacerations) [41]. On the other hand, Garretto et al. reported that the in current clinical practice and physicians should keep in mind that
presence of obesity (BMI  30 kg/m2 was protective against perineal the introduction of several risk factors could further increase the
lacerations (adjusted odds ratio 0.75, 95 % CI 0.58, 0.98)) [45]. risk of perineal lacerations. Therefore, pregnant women that
undergo induction and augmentation of labor, combined with
Discussion epidural anesthesia and who are subjected to episiotomy could
have an even higher risk for developing perineal lacerations,
The findings of our updated meta-analysis are based in a nearly compared to that expected from the univariate analysis of our
double number of articles compared to those of the previous meta- study. Taking in mind this consideration it would be prudent to
analysis published in this field (43 vs 22 articles) [7]. Most of the consider the adoption of a restricted episiotomy policy in order to
investigated outcomes that were associated in the previous meta- minimize the possibility of severe perineal tearing. Maximal effort
analysis with severe perineal lacerations, did also in the present to ensure the perineal integrity should be given as well by
study. An exception to this observation was the use of labor supporting the perineum and by maximizing the angle of
induction which was found marginally significant in the previous episiotomy whenever this maneuver is considered necessary
meta-analysis (OR 1.08, 95 % CI, 1.02, 1.14). The actual reason behind (ex. in forceps delivery).
this finding cannot be explored, however, we may speculate that Future studies are needed to help elucidate factors that were
stricter criteria for labor induction could have been applied since not available, or were poorly investigated, as stated in the
then, given the novel classification system that was proposed at limitations section. Stratification according to the number of risk
2015 by Nippita et al. [59]. A significant observation that was factors that are present at delivery could also help construct robust
observed in the meta-regression analysis of our study was the algorithms with the use of classification and regression trees as
increasing trend of the risk of developing OASIS among studies well as with intelligent hybrid systems such as neuro-fuzzy
investigating the impact of mediolateral episiotomy. Until recently, networks that combine the artificial intelligence of neural
mediolateral episiotomy was considered an actual protective networks (ANNs) with the fuzzy interference environment that
measure against OASIS, however, the previous meta-analysis permit reasoning of the imprecise information that are collected
clearly showed that this was not scientifically proven. from the ANN analysis [61].

Strengths and limitations of the study Conclusions

The present systematic review is based in a meticulous review Several factors are associated with perineal lacerations and the
of the literature which resulted in an almost 100 % increase of present meta-analysis provides accurate risk estimates that may
included studies, compared to the previous meta-analysis that was help physicians during patients counseling. The results of the
conducted in this field [7]. The large number of parturient that was present study may also be used as evidence to help establish
included in each analyzed index permits safe interpretation as the preventive plans that will help minimize the risk of severe perineal
sample size that was reached is adequate. Moreover, the use of lacerations and particularly OASIS in the future.
several secondary analysis helps minimize the possibility of bias
that arises from potential confounders, including the impact of Contribution to authorship
individual studies, of year of publication and used sample size
using an arbitrary cut-off of 1000 patients per study group. VP and SD conceived the idea and wrote the manuscript, VP and
Furthermore, the methodological quality of included studies was MF performed the literature search and wrote the manuscript, MF,
at least acceptable, and in several cases, optimal, therefore IB and NV tabulated the data and wrote the manuscript, VP and IB
minimizing the possibility for selection bias. performed the analysis. MF and NV contributed to the quality
On the other hand, several parameters that deserve further assessment of studies. All authors wrote and critically revised the
investigation in future studies were not available to perform the manuscript.
quantitative analysis, including the impact of obesity, type of
attendant (physician vs midwife), angle of episiotomy as well as Funding
age of parturient (using established WHO classifications for
adolescent and advanced maternal age gravidae). Moreover, sub- The authors did not receive funding for the present work.
V. Pergialiotis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100 99

Ethics statement [23] de Leeuw JW, Struijk PC, Vierhout ME, Wallenburg HC. Risk factors for third
degree perineal ruptures during delivery. BJOG 2001;108:383–7.
[24] Jander C, Lyrenas S. Third and fourth degree perineal tears. Predictor factors in
the present systematic review is based on outcomes already a referral hospital. Acta Obstet Gynecol Scand 2001;80:229–34.
published from previous trials in the field. The study is based on [25] Bodner-Adler B, Bodner K, Kaider A, Wagenbichler P, Leodolter S, Husslein P,
aggregated patient data and no IRB approval was required. et al. Risk factors for third-degree perineal tears in vaginal delivery, with an
analysis of episiotomy types. J Reprod Med 2001;46:752–6.
[26] Riskin-Mashiah S, O’Brian Smith E, Wilkins IA. Risk factors for severe perineal
Declaration of Competing Interest tear: can we do better? Am J Perinatol 2002;19:225–34.
[27] Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal
pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol
The authors report that they have no conflicts of interest to 2004;191:1199–204.
disclose. [28] Eogan M, Daly L, O’Connell PR, O’Herlihy C. Does the angle of episiotomy affect
the incidence of anal sphincter injury? BJOG 2006;113:190–4.
[29] Hudelist G, Gelle’n J, Singer C, Ruecklinger E, Czerwenka K, Kandolf O, et al.
Appendix B. Supplementary data Factors predicting severe perineal trauma during childbirth: role of forceps
delivery routinely combined with mediolateral episiotomy. Am J Obstet
Gynecol 2005;192:875–81.
Supplementary material related to this article can be found, in the [30] Sheiner E, Levy A, Walfisch A, Hallak M, Mazor M. Third degree perineal tears
online version, at doi:https://doi.org/10.1016/j.ejogrb.2020.02.025. in a university medical center where midline episiotomies are not performed.
Arch Gynecol Obstet 2005;271:307–10.
[31] Aukee P, Sundstrom H, Kairaluoma MV. The role of mediolateral episiotomy
References during labour: analysis of risk factors for obstetric anal sphincter tears. Acta
Obstet Gynecol Scand 2006;85:856–60.
[1] The L. Stemming the global caesarean section epidemic. Lancet 2018;392:1279. [32] Dahlen HG, Ryan M, Homer CS, Cooke M. An Australian prospective cohort
[2] Betran A, Torloni M, Zhang J, Gülmezoglu A, Section tWWGoC. WHO statement study of risk factors for severe perineal trauma during childbirth. Midwifery
on caesarean section rates. Bjog Int J Obstet Gynaecol 2016;123:667–70. 2007;23:196–203.
[3] Visser GHA, Ayres-de-Campos D, Barnea ER, de Bernis L, Di Renzo GC, Vidarte [33] Lowder JL, Burrows LJ, Krohn MA, Weber AM. Risk factors for primary and
MFE, et al. FIGO position paper: how to stop the caesarean section epidemic. subsequent anal sphincter lacerations: a comparison of cohorts by parity and
Lancet 2018;392:1286–7. prior mode of delivery. Am J Obstet Gynecol 2007;196(344):e1–5.
[4] Practice bulletin No. 165: prevention and management of obstetric lacerations [34] Kudish B, Blackwell S, McNeeley SG, Bujold E, Kruger M, Hendrix SL, et al.
at vaginal delivery. Obstet Gynecol 2016;128:e1–e15. Operative vaginal delivery and midline episiotomy: a bad combination for the
[5] Leeman L, Rogers R, Borders N, Teaf D, Qualls C. The effect of perineal lacerations perineum. Am J Obstet Gynecol 2006;195:749–54.
on pelvic floor function and anatomy at 6 months postpartum in a prospective [35] Hornemann A, Kamischke A, Luedders DW, Beyer DA, Diedrich K, Bohlmann
cohort of nulliparous women. Birth (Berkeley, Calif) 2016;43:293–302. MK. Advanced age is a risk factor for higher grade perineal lacerations during
[6] Tsakiridis I, Mamopoulos A, Athanasiadis A, Dagklis T. Obstetric anal sphincter delivery in nulliparous women. Arch Gynecol Obstet 2010;281:59–64.
injuries at vaginal delivery: a review of recently published national guidelines. [36] Groutz A, Cohen A, Gold R, Hasson J, Wengier A, Lessing JB, et al. Risk factors for
Obstet Gynecol Surv 2018;73:695–702. severe perineal injury during childbirth: a case-control study of 60
[7] Pergialiotis V, Vlachos D, Protopapas A, Pappa K, Vlachos G. Risk factors for consecutive cases. Colorectal Dis 2011;13:e216–9.
severe perineal lacerations during childbirth. Int J Gynaecol Obstet [37] Groutz A, Hasson J, Wengier A, Gold R, Skornick-Rapaport A, Lessing JB, et al.
2014;125:6–14. Third- and fourth-degree perineal tears: prevalence and risk factors in the
[8] Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The third millennium. Am J Obstet Gynecol 2011;204(347):e1–4.
PRISMA statement for reporting systematic reviews and meta-analyses of [38] Hauck YL, Lewis L, Nathan EA, White C, Doherty DA. Risk factors for severe
studies that evaluate health care interventions: explanation and elaboration. J perineal trauma during vaginal childbirth: a Western Australian retrospective
Clin Epidemiol 2009;62:e1–34. cohort study. Women Birth 2015;28:16–20.
[9] Ghai V, Pergialiotis V, Jan H, Duffy JMN, Doumouchtsis SK. Obstetric anal [39] Schmitz T, Alberti C, Andriss B, Moutafoff C, Oury JF, Sibony O. Identification of
sphincter injury: a systematic review of information available on the internet. women at high risk for severe perineal lacerations. Eur J Obstet Gynecol
Int Urogynecol J 2019;30:713–23. Reprod Biol 2014;182:11–5.
[10] Zhang J, Klebanoff MA, DerSimonian R. Epidural analgesia in association with [40] Hirsch E, Elue R, Wagner Jr A, Nelson K, Silver RK, Zhou Y, et al. Severe perineal
duration of labor and mode of delivery: a quantitative review. Am J Obstet laceration during operative vaginal delivery: the impact of occiput posterior
Gynecol 1999;180:970–7. position. J Perinatol 2014;34:898–900.
[11] Wells GA, Shea B, O`Connel D, Peterson J, Welch V, et al. The Newcastle-Ottawa [41] Hsieh WC, Liang CC, Wu D, Chang SD, Chueh HY, Chao AS. Prevalence and
Scale (NOS) for assessing the quality of nonrandomized studies in meta- contributing factors of severe perineal damage following episiotomy-assisted
analysis. 2011. www.ohri.ca/programs/clinical_epidemiology/oxford.asp. vaginal delivery. Taiwan J Obstet Gynecol 2014;53:481–5.
[12] Egger M, Smith G, O`Rourke K. Why and how sources of heterogeneity should [42] Ampt AJ, Roberts CL, Morris JM, Ford JB. The impact of first birth obstetric anal
be investigated. In: Group BP, editor. Systematic reviews in health care. sphincter injury on the subsequent birth: a population-based linkage study.
London: BMJ Publishing Group; 2001. p. 157–75. BMC Pregnancy Childbirth 2015;15:31.
[13] Botrel TE, Clark O, Pompeo AC, Bretas FF, Sadi MV, Ferreira U, et al. [43] Gauthaman N, Walters S, Tribe IA, Goldsmith L, Doumouchtsis SK. Shoulder
Immunotherapy with Sipuleucel-T (APC8015) in patients with metastatic dystocia and associated manoeuvres as risk factors for perineal trauma. Int
castration-refractory prostate cancer (mCRPC): a systematic review and meta- Urogynecol J 2016;27:571–7.
analysis. Int Braz J Urol 2012;38:717–27. [44] Vale de Castro Monteiro M, Pereira GM, Aguiar RA, Azevedo RL, Correia-Junior
[14] Wallace BC, Dahabreh IJ, Trikalinos TA, Lau J, Trow P, Schmid CH. Closing the MD, Reis ZS. Risk factors for severe obstetric perineal lacerations. Int
gap between methodologists and end-users: R as a computational back-end. J Urogynecol J 2016;27:61–7.
Stat Softw 2012;1(5) 2012. [45] Garretto D, Lin BB, Syn HL, Judge N, Beckerman K, Atallah F, et al. Obesity may
[15] IntHout J, Ioannidis JPA, Rovers MM, Goeman JJ. Plea for routinely presenting Be protective against severe perineal lacerations. J Obes 20169376592 2016.
prediction intervals in meta-analysis. BMJ Open 2016;6:e010247. [46] Gossett DR, Gilchrist-Scott D, Wayne DB, Gerber SE. Simulation training for
[16] Anthony S, Buitendijk SE, Zondervan KT, van Rijssel EJ, Verkerk PH. forceps-assisted vaginal delivery and rates of maternal perineal trauma. Obstet
Episiotomies and the occurrence of severe perineal lacerations. Br J Obstet Gynecol 2016;128:429–35.
Gynaecol 1994;101:1064–7. [47] Kwon HY, Park HS. Episiotomy and the risk of severe perineal injuries among
[17] Labrecque M, Baillargeon L, Dallaire M, Tremblay A, Pinault JJ, Gingras S. Korean women. J Matern Neonatal Med 2017;30:1745–9.
Association between median episiotomy and severe perineal lacerations in [48] Frigerio M, Manodoro S, Bernasconi DP, Verri D, Milani R, Vergani P. Incidence
primiparous women. CMAJ 1997;156:797–802. and risk factors of third- and fourth-degree perineal tears in a single Italian
[18] Klein MC, Janssen PA, MacWilliam L, Kaczorowski J, Johnson B. Determinants scenario. Eur J Obstet Gynecol Reprod Biol 2018;221:139–43.
of vaginal-perineal integrity and pelvic floor functioning in childbirth. Am J [49] Gundabattula SR, Surampudi K. Risk factors for obstetric anal sphincter
Obstet Gynecol 1997;176:403–10. injuries (OASI) at a tertiary centre in south India. Int Urogynecol J
[19] Robinson JN, Norwitz ER, Cohen AP, McElrath TF, Lieberman ES. Episiotomy, 2018;29:391–6.
operative vaginal delivery, and significant perinatal trauma in nulliparous [50] Djakovic I, Ejubovic E, Bolanca I, Markus-Sandric M, Becic D, Djakovic Z, et al.
women. Am J Obstet Gynecol 1999;181:1180–4. Third and fourth degree perineal tear in four-year period at sestre milosrdnice
[20] Jones KD. Incidence and risk factors for third degree perineal tears. Int J university hospital center, Zagreb, Croatia. Open Access Maced J Med Sci
Gynaecol Obstet 2000;71:227–9. 2018;6:1067–71.
[21] Samuelsson E, Ladfors L, Wennerholm UB, Gareberg B, Nyberg K, Hagberg H. [51] Segal D, Baumfeld Y, Yahav L, Yohay D, Geva Y, Press F, et al. Risk factors for
Anal sphincter tears: prospective study of obstetric risk factors. BJOG obstetric anal sphincter injuries (OASIS) during vacuum extraction delivery in
2000;107:926–31. a university affiliated maternity hospital. J. Maternal-Fetal Neonatal Med.
[22] Angioli R, Gomez-Marin O, Cantuaria G, O’Sullivan MJ. Severe perineal 2018;1–5.
lacerations during vaginal delivery: the University of Miami experience. Am J [52] Wilkie GL, Saadeh M, Robinson JN, Little SE. Risk factors for poor perineal
Obstet Gynecol 2000;182:1083–5. outcome after operative vaginal delivery. J Perinatol 2018;38:1625–30.
100 V. Pergialiotis et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 247 (2020) 94–100

[53] Tunestveit JW, Baghestan E, Natvig GK, Eide GE, Nilsen ABV. Factors associated [58] Chen SJ, Chen CP, Sun FJ, Chen CY. Factors associated with obstetric anal
with obstetric anal sphincter injuries in midwife-led birth: a cross sectional sphincter injuries during vacuum delivery among Chinese women. Int J
study. Midwifery 2018;62:264–72. Gynaecol Obstet 2019;145:354–60.
[54] Sano Y, Hirai C, Makino S, Li X, Takeda J, Itakura A. Incidence and risk factors of [59] Nippita T, Khambalia A, Seeho S, Trevena J, Patterson J, Ford J, et al. Methods
severe lacerations during forceps delivery in a single teaching hospital where of classification for women undergoing induction of labour: a systematic
simulation training is held annually. J Obstet Gynaecol Res 2018;44:708–16. review and novel classification system. Bjog Int J Obstet Gynaecol
[55] Ramm O, Woo VG, Hung YY, Chen HC, Ritterman Weintraub ML. Risk factors for 2015;122:1284–93.
the development of obstetric anal sphincter injuries in modern obstetric [60] Jango H, Westergaard HB. Changing incidence of obstetric anal sphincter
practice. Obstet Gynecol 2018;131:290–6. injuries-A result of formal prevention programs? Acta Obstet Gynecol Scand
[56] D’Souza JC, Monga A, Tincello DG. Risk factors for perineal trauma in the primiparous 2019;98:1455–63.
population during non-operative vaginal delivery. Int Urogynecol J 2019. [61] Gupta MM. Fuzzy logic and neural networks. IEEE Trans Neural Netw 1992;3
[57] Gommesen D, Nohr EA, Drue HC, Qvist N, Rasch V. Obstetric perineal tears: risk (5):636–9.
factors, wound infection and dehiscence: a prospective cohort study. Arch
Gynecol Obstet 2019;300:67–77.

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