Principal findings
In the present study-, no difference was found between the women randomized to the selective episiotomy group compared to those randomized to the non-episiotomy group. The overall rate of episiotomy was very low (around 1.7%), similar in the two groups, and close to the low rates already described by other authors [9, 12]. The episiotomy rate found in the present study is well below the maximum of 10% recommended by the WHO [3], and much lower than the overall episiotomy rate found in a Cochrane systematic review of around 28% in the group submitted to selective episiotomy [5].
Strengths and weaknesses
Episiotomy was introduced into obstetric practice without any scientific evidence corroborating any possible benefits [13]. Its use became widespread in the twentieth century based on the recommendation of renowned obstetricians such as Gabbe and DeLee [14]. The paradigm that existed at that time was interventionist to the extreme in that the female body was believed to be essentially defective and dependent on medical interventions to enable childbirth to take place [15]. This belief, together with a change in the place of childbirth, away from the home and into the hospital environment, contributed to the popularization of the procedure in hospitals [13]. It was only in the 1970s that discordant voices began to be heard, generally from within women’s movements, demanding changes in the obstetric model [13].
The review published by Thacker and Banta in 1983 not only highlighted the lack of any scientific studies supporting the use of episiotomy, but also found the practice to be potentially associated with harmful consequences such as perineal pain, hematoma, infection, dyspareunia and healing complications [16]. In 1984, the results of the first randomized clinical trial on the subject were published. That study, conducted in the United Kingdom, reported an episiotomy rate of 10% when the proposal was to perform the procedure selectively [4]. Various other randomized clinical trials followed and are summarized in a Cochrane systematic review. The well-documented advantages of restricting the practice of episiotomy rather than encouraging its routine use include less risk of posterior perineal trauma and of severe perineal trauma. Other positive consequences are less blood loss, less need for sutures, a lower frequency of postpartum perineal pain, a lower risk of perineal suture complications (oedema, dehiscence, infection and hematoma), fewer cases of postpartum loss of perineal muscle strength and less risk of dyspareunia [5].
A question that has recently been raised is whether there is indeed any indication for performing episiotomy and whether the procedure, even when practiced selectively, confers any benefit at all, either immediately or later [1, 6, 9]. Indications such as a prolonged second stage, macrosomia, non-reassuring fetal heart rate, instrumental delivery, occiput posterior position, pelvic delivery and shoulder dystocia have been questioned [9]. A systematic review of the effectiveness of episiotomy for prevention and management of shoulder dystocia found no evidence supporting the use of episiotomy [17]. The American College of Obstetricians and Gynecologists recognizes that there is insufficient objective evidence-based criteria to define the indications for episiotomy – and that restrictive use of episiotomy remains the best practice [2].
Strengths and weaknesses in relation to other studies
In one study that included 168,077 vaginal births at the University of Soroka Medical Centre, Israel, mediolateral episiotomy was found to be an independent risk factor for third and fourth degree perineal lacerations, even in critical situations such as shoulder dystocia, instrumental deliveries, posterior presentations, fetal macrosomia and non-reassuring fetal heart rate. The episiotomy rates at that hospital fell from over 30% in the 1990s to less than 5% in 2010 [12].
Using a non-episiotomy protocol associated with strategies aimed at protecting the perineum, Amorim et al. reported an intact perineum rate of approximately 60%, with only 23% of women requiring perineal suturing [9, 18]. That study, however, was not controlled and was conducted with a specific sample of women, and the authors recommended that randomized clinical trials should be performed to compare a non-episiotomy policy with one of selective episiotomy. However, other observational studies corroborate that it is possible to avoid episiotomy and achieve a high rate of intact perineum. In other larger series of 1,176 women with natural births without episiotomy, an intact perineum rate of almost 65% was reported with 20% of perineal suture need [19]. Recently, a retrospective study conducted in Tokyo, Japan, including 1,1521 women with spontaneous births without interventions (epidural, episiotomy, instrumental delivery) reported intact perineum rates of 49.5% in nulliparous and 69.9% in multiparous women, with only 0.1% of third-degree laceration (one case) [20].
Notwithstanding, all above mentioned studies were observational, descriptive, uncontrolled studies with the limitations inherent to the study design and until this moment we did not identify any randomized controlled trial with the objective to determine if episiotomy is necessary in any circumstance. The current recommendation of selective episiotomy is based on the conclusions of systematic reviews of clinical trials that demonstrated selective episiotomy was better than routine episiotomy [5, 25] and the authors of the original clinical trials did not “dare” to address the question if it is possible to never perform episiotomies for vaginal deliveries, the results and safety of definitively abolishing this procedure of the modern obstetric practice.
The present study is the first randomized clinical trial to compare the restricted use of episiotomy with a non-episiotomy protocol, thus classifying its results as representing an original contribution to the current literature. The advantages of the study include its design, in which the women were randomly allocated to one of two groups, and the sample size, which was sufficient to show any possible benefits or harmful effects in either of the two groups. The analysis was performed on an intention-to-treat basis, which explains the two cases of episiotomy in the group of women randomized to the non-episiotomy group. Since the indications recorded for these episiotomies were a “prolonged second stage” associated with non-reassuring fetal heart rate, the procedure may have been avoidable. Likewise, in the selective episiotomy group, the two episiotomies performed because of a “prolonged second stage” may have been unnecessary. The considered limits for the duration of the second stage are currently more flexible. If mother and baby are well, patience to wait without intervening could have avoided some of the procedures performed [21,22,23].
However, the present randomized clinical trial may have been performed too late at this hospital, where episiotomy rates have been falling for the past ten years, reaching a level below 2% within the context of selective practice in this study. This change in the paradigm could explain these results. Since this study was conducted at one single centre, further randomized clinical trials need to be carried out, preferably in places where selective episiotomy rates are higher in order to verify whether there really are any relevant differences when the procedure is performed, even with restricted indications, versus when there is no intention to ever perform the procedure. Ideally, a future systematic review could include randomized clinical trials conducted for this purpose to enable solid recommendations to be proposed for routine obstetric practice.
Explanations and implications for clinicians and policymakers
Until the results of such studies are available, it appears reasonable to propose that the World Health Organization redefine its cut-off point for the “ideal” episiotomy rate and, in an effort to reduce rates, that nurses, midwives and doctors be trained not to perform the procedure indiscriminately.
Despite the consistent evidence against its indiscriminate practice [5], in some places episiotomy is still performed routinely and indeed a recent study published in Brazil showed a rate of 54% in this country [24]. This rate is more than five times the maximum rate recommended by the World Health Organization and means that a large number of healthcare professionals (particularly doctors, since in the current obstetric model in Brazil the majority of deliveries are performed by doctors) still carry out this procedure systematically. This may imply additional costs for the healthcare system, since, just in suture threads, savings between $6.50 and $12.50 could be made with each vaginal delivery. Carroli and Belizan evaluated that this could represent a current annual saving of US$ 15 to 30 million for Brazil [25].
Furthermore, routine episiotomy is now considered a form of obstetric violence, particularly when performed without informed consent. A relatively new legal term, “obstetric violence” is used to describe a situation in which any form of labor in childbirth is considered pathological, when a woman is automatically transformed into a patient and when routine medical and pharmacological procedures are carried out without giving the woman the right to make her own decisions with respect to her own body [26]. Routinely performing procedures that, in addition to being unnecessary, may be harmful, characterizes mistreatment during childbirth [27]. In this context, routine or high rates of episiotomy can be categorized as female genital mutilation [28].
Unanswered questions and future research
Within this context, it is important to define whether episiotomy is really necessary in any situation and what, if any, are its true indications. In addition to the harmful effects that may be associated with episiotomy and the costs of the procedure to the healthcare system, this question also deals with issues of reproductive rights.
It may seem curious that a procedure would be incorporated into obstetric practice without a shred of evidence of its beneficial effects and our task now is to generate evidence to determine whether its use is in fact necessary at any childbirth. This evidence should have been sought in the past. As Cochrane said: “One should…always assume that a treatment is ineffective unless there is evidence to the contrary” [29]. Unfortunately, the randomized clinical trials that were published following publication of the paper by Thacker and Banta did not compare the non-performance of episiotomy with the routine practice of this procedure [30, 31].
It is hoped that this study may contribute towards significantly reducing episiotomy rates in Brazil and in other places where routine episiotomy is still performed. According to a recent study comparing rates of episiotomy in 20 European countries found important differences, varying from 3,7% in Denmark to 75% in Cyprus [32]. In other institutes and in other countries in which episiotomy is practiced selectively, the present results are expected to encourage further studies to find answers to the more decisive questions: Is it time to stop performing episiotomies? Have we actually reached the point of proposing to abolish episiotomy? It is our belief that, yes, this is the end of the cut.
