How did episiotomy rates change from 2007 to 2014? Population-based study in France

How did episiotomy rates change from 2007 to 2014? Population-based study in France Background: Since the 2000s, selective episiotomy has been systematically recommended worldwide. In France, the recommended episiotomy rate in vaginal deliveries is less than 30%. The aims of this study were to describe the evolution of episiotomy rates between 2007 and 2014, especially for vaginal deliveries without instrumental assistance and to assess individual characteristics and birth environment factors associated with episiotomy. Methods: This population-based study included all hospital discharge abstracts for all deliveries in France from 2007 to 2014. The use of episiotomy in vaginal deliveries was identified by one code in the French Common Classification of Medical Procedures. The episiotomy rate per department and its evolution is described from 2007 to 2014. A mixed model was used to assess associations with episiotomy for non-operative vaginal deliveries and the risk factors related to the women’s characteristics and the birth environment. Results: There were approximately 540,000 non-operative vaginal deliveries per year, in the study period. The national episiotomy rate for vaginal deliveries overall significantly decreased from 26.7% in 2007 to 19.9% in 2014. For non-operative deliveries, this rate fell from 21.1% to 14.1%. For the latter, the use of episiotomy was significantly associated with breech vaginal delivery (aOR = 1.27 [1.23–1.30]), epidural analgesia (aOR = 1.45 [1.43–1.47]), non-reassuring fetal heart rate (aOR = 1.47 [1.47–1.49]), and giving birth for the first time (aOR = 3.85 [3.84–4.00]). Conclusions: The episiotomy rate decreased throughout France, for vaginal deliveries overall and for non-operative vaginal deliveries. This decrease is probably due to proactive changes in practices to restrict the number of episiotomies, which should be performed only if beneficial to the mother and the infant. Keywords: Episiotomy, Birth, Vaginal deliveries, Hospital discharge abstracts Background from country to country. In Latin America from 1995 to Historically, episiotomy is a surgical incision of the vaginal 1998, the median episiotomy rate for primiparous women orifice performed to reduce severe perineal tears, per was 92.3% [5]. In 2000–2001, episiotomy rates were 23.8% partum fetal asphyxia during the fetal expulsion stage of in Canada and 32.7% in the United States while it was birth and subsequent urinary or fecal incontinence [1–3]. 100% in Taiwan in 2002. In Europe, the rates varied In the 1980s–1990s, episiotomy was routinely performed. widely: 9.7% in Sweden in 1999–2000, 12.0% in Denmark, In France, in 1998, the rate of episiotomy, usually medio- 13.0% in England, 44.4% in Germany in 2002–2003, and lateral, was 71.3% for primiparous women and 36.3% for 58.0% in Italy in 1999 [6]. multiparous women [4]. This rate varied considerably Since 1990, randomized controlled trials have ques- tioned the routine use of episiotomy, which does not * Correspondence: catherine.quantin@chu-dijon.fr seem to provide more benefits than a selective practice. Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; Indeed, restrictive episiotomy practice was associated Bourgogne Franche-Comté University, Dijon, France with a higher risk of anterior perineal trauma but not Inserm, CIC 1432, Dijon, France; Dijon University Hospital, Clinical Investigation Center, clinical epidemiology/ clinical trials unit, Dijon, France with perineal infection, moderate or severe pain, long- Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 2 of 10 term dyspareunia or long-term urinary incontinence, or gestational age (available only since 2010), multiple an Apgar score less than seven at five minutes in the new- pregnancy, epidural analgesia, non-reassuring fetal born child [3, 7–11]. Currently, selective episiotomy practice heart rate, breech vaginal delivery, newborn weight > is systematically recommended, and some authors and 4000 g (for single pregnancies, linkage with the birth policy statements state that episiotomy should be avoided abstract reliable only since 2013). We also considered if at all possible [10–13]. However, guidelines are relatively severe perineal tear: third degree (injury to the anal disparate regarding the most appropriate episiotomy rate. sphincter complex) and fourth degree (injury to the In 1992, Henriksen suggested an appropriate rate of 20% perineum involving the anal, or sphincter complex and [14]. In 1996, the World Health Organization recom- anal epithelium) [8]. Variables retained for the environ- mended a target rate of 10% [15]. Furthermore, the effective ment were the year of delivery, and department (French implementation of evidence-based healthcare practices regions are divided into geographical departments). remains a significant challenge. In 2005, as the episiotomy rate had already reached 41.3% [16], the French National Statistical analysis College of Gynecologists and Obstetricians recommended a The characteristics are presented as means or proportions. more restrictive practice based on « the clinical expertise of Percentages were compared using Pearson’s Chi 2 test or the physician », at less than 30% of vaginal deliveries [17]. Fisher’s exact test under the conditions of application. To To our knowledge, no studies have examined the recent evaluate trends in episiotomy rates between 2007 and trend in episiotomy rates in France as a whole even though 2014, we used the Cochran-Armitage test. the guidelines are about 12 years old. The aim of the Episiotomy rates in 2007 and 2014 are presented per present study was to describe the evolution of episiotomy department (97 departments, including overseas territories). rates from 2007 to 2014, especially for non-operative A mixed model was used to assess associations with vaginal deliveries. We also studied the clinical and birth risk factors. As the independence of the observations environment factors associated with episiotomy. could not be confirmed, hierarchical logistic regression, which took into account the hierarchical structure of Methods data, was performed using the individual maternal vari- In this population-based retrospective cohort study, we ables as level 1 data, and the hospital as level 2 data. included all hospital discharge abstracts for all deliveries in Multilevel analyses were performed using SAS 9.4. France from 2007 to 2014. Diagnoses were coded according Geographic Information System MapInfo 11.0 was used to the International Classification of Diseases (ICD-10) and for the cartography. procedures according to the French Common Classification This study was approved by the French Committee for of Medical Procedures (CCMP). Data Protection (Commission Nationale de l’Informatique et des Libertés, registration number 1576793) and was Population conducted in accordance with French legislation. Written All hospital discharge abstracts mentioning the codes consent was not needed for this study. The national Z37 (“outcome of delivery”) of the ICD-10 were selected. hospital database was transmitted by the national agency In France, Z37 codes are considered the most reliable for the management of hospitalization data (ATIH number and exhaustive to select hospital deliveries. All vaginal 2015–111111–47-33). deliveries were examined, but we especially focused on non-operative vaginal deliveries (the related codes are Results described in the Additional file 1). There were about 800,000 deliveries per year (minimum 790,994 in 2007 and maximum 815,396 in 2010). The Variables percentage of vaginal deliveries was very stable, ranging In the present study, the outcome of interest was episi- from 79.74% in 2007 to 79.59% in 2014. The proportion of otomy, which was defined by one code in the CCMP non-operative vaginal deliveries slightly decreased from 68. (JMPA006). The quality of hospital discharge abstracts 59% in 2007 to 67.57% in 2014. regarding episiotomy has been validated thanks to a French For all vaginal deliveries or for non-operative vaginal validation study [18]. Unfortunately, to our knowledge, no deliveries, the nationwide episiotomy rate significantly validity studies have used national data to study episiotomy decreased (p < 0.01) from 26.7% (21.1% for non-operative in non-operative vaginal deliveries. vaginal deliveries) in 2007 to 19.9% (respectively 14.1%) in The explanatory variables concerned the characteristics 2014. This was also the case for episiotomy rates in in- of the women and the characteristics of birth environment. strumental deliveries (61.0% in 2007 vs 52.6% in 2014, At the maternal level, we considered the known risks p <0.01). factors for episiotomy: maternal age, parity (primiparous Then, we focused on non-operative vaginal deliveries. women were women who gave birth for the first time), The characteristics of women are presented in Table 1. For Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 3 of 10 women who underwent non-operative vaginal deliveries, the difference in the total number of deliveries when the average maternal age was 29–30 years (+/− 5 years), compared with the national civil registry, which records slightly more than one third of women were primiparous all births in France, was only 0.3% [19]. The National womenand about 93% of womenhad givenbirth at 37 to Perinatal Survey in 2010 showed a vaginal delivery rate of 41 weeks of amenorrhea (2010–2014). 79.0% and a non-operative vaginal delivery rate of 66.9% For non-operative vaginal deliveries, Figs. 1 and 2 [4]. Our results were 79.4% for all vaginal deliveries and present the distribution of episiotomy rates per department 67.7% for non-operative vaginal deliveries. in 2007 and 2014, respectively. Inter-departmental disparity In 2012, at the individual level, a validation study was was as high in 2007 (ranging from 4.0% to 39.9%) as in performed to evaluate the metrological quality of hospital 2014 (ranging from 1.4% to 33.9%). The episiotomy rate discharge abstracts for perinatal indicators. The validity decreased by 25 to 75% from 2007 to 2014 for the majority study concerned the same data but only from three of geographic departments as shown in Fig. 3.The university hospitals which agreed to provide a comparison episiotomy rate, which was higher than 30% in 14 between hospital discharge abstracts and medical records. departments (about 15% of the 97 departments) in 2007, For vaginal deliveries, the positive predictive value (PPV) reached a high rate (33.9%) in only one department in was 99.5% [98.5–100] and the sensitivity (Se) was 100%. 2014. For episiotomy, irrespective of the vaginal mode of delivery, Regarding the rate of severe perineal tears (third and the PPV was 88.9% [79.7–98.1] and the Se was 90.9% fourth degree) for non-operative vaginal deliveries, we [82.4–99.4]. For perineal tears in vaginal deliveries, the observed a significant increase between 2007 and 2014, PPV was 94.3% [89.9–98.7] and the Se was 88.6% [82.8– for women with episiotomy (0.4 to 0.8%, p < 0.01) and 94.4] [18]. In France, no data from validation studies are without episiotomy (0.2 to 0.4%, p < 0.01). The distribu- available for severe perineal tears in cases of non- tion of severe perineal tears is presented in the Appendix operative vaginal deliveries. However, in 2010, the rate (Additional file 2). of severe perineal tears for vaginal deliveries was 0.6% in The results of the multilevel logistic regression analyses our study, while the rate was estimated at 0.8% ([0.6–0.9]) are shown in Table 2 for different periods, for non- in the National Perinatal Survey [4]. operative vaginal deliveries. From 2007 to 2014, singleton Moreover, our population-based study allowed us to pregnancy was associated with a decrease in the use of examine some groups like breech vaginal deliveries or episiotomy (adjusted Odds Ratio (aOR) = 0.74, Confidence multiple deliveries with large sub-populations. These interval 95% [0.72–0.76]), as was maternal age under national data also allowed us to take into account the 20 years (aOR = 0.89 [0.87–0.91]). Breech vaginal delivery effects of the health facility or the variability in hospital (aOR = 1.27 [1.23–1.30]), epidural analgesia (aOR = 1.45 medical practices as we included a specific level for [1.43–1.47]), non-reassuring fetal heart rate (aOR = 1.47 hospitals in our multilevel model (level 2 of the model). [1.47–1.49]), and giving birth for the first time (aOR = 3. The main limitation of this study was related to differ- 85 [3.84–4.00]) were significantly associated with a higher ences in coding practices. In the validation study in 2012, risk of episiotomy. In addition to the significant variables we examined divergent cases for the discussion. During mentioned above, we found that giving birth before interviews, we were able to discern that some physicians 41 weeks of amenorrhea (from 2010 to 2014) and newborn could seldom report the code for episiotomy in cases of weight lower than 4000 g (from 2013 to 2014) significantly delivery with instrumental assistance, considering that (p < 0.0001) decreased the risk of episiotomy. episiotomy is a classical part of this delivery procedure. As regards all vaginal deliveries, the results of the ana- For this reason, we decided to focus on non-operative lyses were similar (Additional file 3). vaginal deliveries. All tables and figures were restricted to these cases. The results for all vaginal deliveries are Discussion only given for information (Additional file 3), as we Over the last few years, the episiotomy rate significantly know that they may be underestimated. However, when decreased at national and departmental level. In 2014, an episiotomy is coded, this episiotomy is generally for non-operative vaginal deliveries, the national rate performed. and the rates for all of the geographic departments Our results are consistent with previous studies except one were below 30%. These results suggest that regarding factors associated with the use of episiotomy. the recommendations have been seriously taken into We retrieved the usual risk factors: primiparous women, account and that proactive changes in practices to restrict multiple pregnancies, breech vaginal deliveries, epidural the use of episiotomy have been implemented nationwide. analgesia, non-reassuring fetal heart rate, newborn weight > One of the strengths of our study was to include 4000 g [20–23]. In France, episiotomy is not systematically nearly all deliveries, thanks to national discharge abstract used in breech vaginal deliveries. Indeed, the episiotomy data, as almost all deliveries occur in hospitals in France: rate decreased from 57% in 1994 to 28.4% in 2009–2010 Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 4 of 10 Table 1 Characteristics of women who underwent non-operative vaginal deliveries 2007 2008 2009 2010 2011 2012 2013 2014 Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No episiotomy episiotomy episiotomy episiotomy episiotomy episiotomy episiotomy episiotomy Maternal agel 29 +/− 530+/−529+/− 530+/−529+/− 530+/−529+/−530+/−529+/−530+/−529+/− 530+/−529+/− 530+/−529+/− 530+/− 5 (years) Primiparous 60.6 31.6 61.3 32 62.7 32.7 63.8 32.8 63.9 32.1 64.1 31.7 64.1 31.5 64,0 31.6 *£ women Multiple 1.1 0.8 1.1 0.8 1.1 0.7 1.1 0.8 1.1 0.8 1.1 0.8 1,0 0.8 1.1 0.8 pregnancies Breech vaginal 2.1 1.2 2.1 1.3 2.1 1.3 2.2 1.3 2.2 1.4 2.2 1.4 2.3 1.5 2.4 1.5 delivery Perineal tears 0.4 0.2 0.5 0.3 0.5 0.3 0.5 0.3 0.6 0.3 0.6 0.3 0.7 0.4 0.8 0.4 (third and fourth degrees) Gestational age < 37 WA£–– – 4.1 6.1 4 6.1 3.9 6.2 3.9 6.2 3.9 6.1 37–41 WA£–– – 95.1 93.3 95.1 93.2 95.2 93,0 95.2 93.1 95.2 93.2 > 41 WA£–– – 0.8 0.6 0.9 0.7 0.9 0.8 0.9 0.7 0.9 0.7 WA = weeks of amenorrhea, * Missing Data < 1,5% p < 0.01 Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 5 of 10 Fig. 1 Distribution of episiotomy rates for non-operative vaginal deliveries in 2007 [24]. Although the restrictive practice of episiotomy has our estimation (11.3%, all over the corresponding de- been established by evidence-based medicine, the indica- partment) but the 2009 study included only one hospital tions to perform episiotomy are still a matter of debate. and only single pregnancies and cephalic presentations In France, even though, to our knowledge, no national [26]. Another study based on Burgundy Perinatal Network rates have been published for all hospitals, some studies data showed similar results to ours in the four departments have been performed, and their results seem to agree included in this region [27]. A study conducted in the south with ours. A first study in 2007, which concerned vaginal of France reported a decrease in the rate of episiotomy deliveries in university hospitals, estimated a national (from 35.8% in 2003–2005 to 16.7% in 2012–2014) [20]. All episiotomy rate of 32.4%. It is not surprising that our es- these studies highlight a high disparity in episiotomy rates timation for vaginal deliveries in 2007 (26.7%) was lower not only between departments but also between hospitals. as we considered all hospital types [25]. In 2009, another In our study, a decrease in episiotomy rates was shown for study in one hospital estimated the episiotomy rate in the vast majority of French departments from 2007 to vaginal deliveries at 7.6%. This figure is slightly below 2014. Over the same period, severe perineal tears (third and Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 6 of 10 Fig. 2 Distribution of episiotomy rates for non-operative vaginal deliveries in 2014 fourth degrees) significantly increased in women who had does not stem from coding problems in hospital data. An- non-operative vaginal deliveries. These results were consist- other explanation could be non-diagnosis [33], which none- ent with those of the Euro-peristat project, which described theless seems to be diminishing over time. In fact, we an increase in the rate of severe perineal tears for all vaginal observed an increase in severe perineal tears in France deliveries between 2004 and 2010 in all European countries, which may be related to improvements in vigilance and except Germany and Norway [28]. This issue is still the the training of professionals in the diagnosis and sutur- subject of a controversial debate [7, 9, 20, 29–32]. Random- ing of these severe perineal tears which are responsible ized trials showed no increase in severe perineal tears re- for urinary and fecal incontinence [29]. lated to the restrictive use of episiotomy [3]. On the We can notice that, for non-operative vaginal deliveries, contrary our results showed that the restrictive practice of the rate decreased markedly in all departments (decrease episiotomy was associated with a greater risk of severe peri- of 25 to 75%), even when initial rates were about 30%. In neal tears. However, the rate in France is lower than the 2014, 14 of the 97 departments presented an episiotomy mean rate found in EURO-PERISTAT, which suggests that rate below 10% for non-operative vaginal deliveries. The the rate is under-estimated in France. Given that the rate rate of severe perineal tears was unavailable for two of these found in our study is in keeping with that found in the na- departments, between 0.15 and 0.58% for ten departments tional perinatal survey, it is likely that this under-estimation and above 1% for two departments. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 7 of 10 Fig. 3 Evolution of episiotomy rates for non-operative vaginal deliveries from 2007 to 2014 It seems difficult to define what could be the right obtained in 57% of French departments with a rate of se- episiotomy rate in France. The WHO recommended a vere perineal tears not more than 1%. As a consequence, target of 10% for episiotomy. This recommendation can- one could hypothesize than a rate of 15% could be not be generalized as it was based on a case-controlled reached by most departments in a reasonable time. Fur- study that included only non-induced labor for a single ther research is of course needed to confirm this pregnancy at over 37 weeks of amenorrhea. Moreover, it hypothesis. took into account the high infection rate in developing This target rate can be considered achievable for all countries, which is not the case in France. The restrict- French departments, though a national program is neces- ive practice of episiotomy must provide an episiotomy sary. A passive approach after the publication of guidelines rate that is optimal for children’s and mothers’ health is not enough and the implementation of evidence-based and ensure low rates of severe perineal tears, which are practices remains a real challenge. Previous publications very harmful for women. Our results suggest that a rate have shown that the impact of guidelines is greater if they below 15% for non-operative vaginal deliveries was are worked on with the teams concerned, particularly in Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 8 of 10 Table 2 Hierarchical logistic regressions, non-operative vaginal deliveries Episiotomy (2007–2014) Episiotomy (2010–2014) Episiotomy (2013–2014) aOR 95% CI aOR 95% CI aOR 95% CI Maternal age (ref ≥ 40 years) < 20 0.89 [0.87–0.91] 0.89 [0.86–0.92] 0.85 [0.81–0.90] 20–29 1.03 [1.01–1.05] 1.03 [0.99–1.04] 0.98 [0.94–1.02] 30–39 1.09 [1.07–1.12] 1.07 [1.05–1.09] 1.04 [1.01–1.08] aa Single pregnancy (ref = 0) 0.74 [0.72–0.76] 0.57 [0.55–0.59] Breech vaginal delivery (ref = 0) 1.27 [1.23–1.30] 1.45 [1.41–1.48] 1.59 [1.49–1.67] Epidural analgesia (ref = 0) 1.45 [1.43–1.47] 1.43 [1.43–1.45] 1.47 [1.45–1.52] Non-reassuring fetal heart rate (ref = 0) 1.47 [1.47–1.49] 1.49 [1.47–1.52] 1.49 [1.47–1.54] Status of health establishment (ref = Private) 1.33 [1.12–1.56] 1.30 [1.09–1.54] 1.37 [1.15–1.64] Year of delivery (ref = 2014) 2007 1.63 [1.61–1.64] aa a a 2008 1.58 [1.56–1.60] aa a a 2009 1.46 [1.44-1.48] aa 2010 1.37 [1.36-1.39] 1.37 [1.35–1.38] aa 2011 1.31 [1.29-1.32] 1.30 [1.29–1.32] aa 2012 1.21 [1.20-1.23] 1.21 [1.20–1.23] 2013 1.13 [1.12-1.15] 1.13 [1.12–1.15] 1.13 [1.11–1.14] Parity (ref = multiparous women) 3.85 [3.84–4.00] 4.00 [4.00–4.17] 4.17 [4.17–4.35] Gestational age (ref > 41 WA) bb < 37WA 0.42 [0.40-0.44] 0.42 [0.39–0.45] bb 37-41WA 0.82 [0.79-0.85] 0.82 [0.77–0.87] bb bb Newborn weight (ref < 4000 g) 1.54 [1.49-1.56] aOR: Adjusted Odds ratio, CI: Confidence Interval, WA: Weeks of Amenorrhea Not studied Not available in database Only single pregnancy obstetrics [34]. At the national level, a community of practitioners, gain their support in implementing a re- practices could promote the dissemination of experience, strictive practice policy for episiotomy. Perinatal networks and thus decrease the episiotomy rate without increasing havearole toplayinstandardizing therestrictive useof severe perineal tears. episiotomy in the areas they cover. Our study suggests that the action plan should now be looking at the individual level. Some authors have described how a private and confidential feedback from Conclusions physicians about their own practices can induce a Our study described the evolution of episiotomy rates in decrease in the use of episiotomy [35, 36]. Ambassadors France following the recommendations of the National with communication and training skills may effectively College of Gynecologists and Obstetricians. We showed that facilitate changes in their teams [37]. In the same way, the use of episiotomy in non-operative vaginal deliveries fell audits, risk management approaches, continuous care significantly from 21.1% in 2007 to 14.1% in 2014 at the na- quality improvement programs and the understanding of tional and departmental level. However, at the departmental professionals’ behavior with regard to perineum protection level, theepisiotomyrates stillrangedfrom1.4%to33.9%. should lead to the standardization of good practices for To reduce the still present disparities without impairing the selective episiotomy. health of women and their children, it is necessary to act at The continuous training of physicians and midwives is the individual level and to encourage every professional to an important lever to improve quality of care. Perinatal think about his/her use of episiotomy in the light of clear, networks, which aim to inform, train and motivate relevant indicators. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 9 of 10 Additional files University Hospital, Clinical Investigation Center, clinical epidemiology/ clinical trials unit, Dijon, France. Inserm, CIC 1432, Dijon, France ; Dijon University Hospital, Clinical Investigation Center, clinical epidemiology/ Additional file 1: ICD-10 codes and CCMP codes. Description of codes clinical trials unit, Dijon, France. used for identification of delivery modes and risk factors. (DOCX 14 kb) Additional file 2: Figure: Distribution of severe perineal tears rates for Received: 1 August 2017 Accepted: 19 April 2018 non-operative vaginal deliveries in 2014. The figure presents the rate of severe perineal tears per department, in 2014, in France. (DOCX 246 kb) Additional file 3: Table: Hierarchical logistic regressions, all vaginal References deliveries. The table presents the association between the episiotomy 1. Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative and risk factors, for all vaginal deliveries. (DOCX 18 kb) review of the english language literature, 1860–1980. Obstet Gynecol Surv. 1983;38:322–38. 2. Cunningham FG. Conduct of normal labor and delivery. In: Cunningham FG, Abbreviations MacDonald PC, Gant NF, Leveno KJ, Gilstrap LCIII, editors. Williams aOR: Adjusted Odds Ratio; CCMP: Common Classification of Medical obstetrics. 19th edition. Appleton and Lange; Norwalk, CT; 1993. p. 371–93. Procedures; CI: Confidence Interval; ICD-10: International Classification of 3. Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database Syst Diseases-version10; PPV: Positive Predictive Value; Se: Sensitivity; WA: Weeks Rev. 2009;1:CD000081. of Amenorrhea 4. Blondel B, Lelong N, Kermarrec M, Goffinet F. Trends in perinatal health in France between 1995 and 2010: results from the national perinatal surveys. Acknowledgements J Gynecol ObstetBiol Reprod (Paris). 2012;41:151–66. The authors thank Philip Bastable for reviewing the English. 5. Althabe F, Belizan JM, bergel E. Episiotomy rates in primiparous women in Latin America: hospital based descriptive study. BMJ. 2002;324(7343):945–6. Funding 6. Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the This research did not receive any specific grant from funding agencies in the world: an update. Birth. 2005;32(3):219–23. public, commercial, or not-for-profit sectors. 7. Argentine episiotomy trial collaborative group. Routine vs selective episiotomy: a randomised controlled trial. Lancet. 1993;342:1517–8. Availability of data and materials 8. Dannecker C, Hillemanns P, Strauss A, Hasbargen U, Hepp H, Anthuber C. The hospital database was transmitted by the national agency for the Episiotomy and perineal tears presumed to be imminent: randomized management of hospitalization data. The use of these data by our controlled trial. Acta Obstet Gynecol Scand. 2004;83:364–8. department was approved by the National Committee for data protection. 9. Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of The French Committee for Data Protection who approved our study did not episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017;2:CD000081. approve the sharing of raw data. 10. American College of Obstetricians-Gynecologists. ACOG practice bulletin. Episiotomy. Clinical management guidelines for obstetrician-gynecologists. Authors’ contributions Number 71, April 2006. Obstet Gynecol. 2006;107(4):957–62. KG, JC conceptualized and designed the study, interpreted the data and 11. Berghella V, Baxter JK, Chauhan SP. Evidence-based labor and delivery wrote the paper. AR conducted the cartographical analysis, and contributed management. Am J Obstet Gynecol. 2008;199:445–54. substantially to writing the manuscript. CC, PS participated in the 12. Cargill Y, MacKinnon C. The clinical practice obstetrics committee. Guidelines interpretation of the results reviewed and revised the manuscript drafts. CQ for operative vaginal birth. J Obstet Gynaecol Can. 2004;26(8):747–53. oversaw the data analysis and interpretation, and contributed substantially to 13. National Collaborating Centre for Women’s and Children’s Health. writing the manuscript. All authors accept responsibility for the paper as Intrapartum care: care of healthy women and their babies during childbirth. published. All authors read and approved the final manuscript. In: RCOG press; 2017. 14. Henriksen TB, Bek KM, Hedegaard M, Secher NJ. Episiotomy and perineal lesions Ethics approval and consent to participate in spontaneous vaginal deliveries. Br J Obstet Gynaecol. 1992;(12):950–4. This study was approved by the French Committee for data protection 15. World Health Organization, Department of Reproductive Health and (registration number 1576793) and therefore was conducted in accordance with Research. Care in normal birth: a practical guide. 1996. WHO/FRH/MSM/96. the Declaration of Helsinki. Written consent was not needed for this study. The 24 Available at http://apps.who.int/iris/bitstream/10665/63167/1/WHO_FRH_ hospital database was transmitted by the national agency for the management MSM_96.24.pdf of hospitalization data (ATIH, registration number 2015–111111–47-33). Written 16. Clesse C, Lighezzolo-Alnot J, Hamlin S, De Lavergne S, Scheffler M. The consent was not needed for this study. practice of episiotomy in France 10 years after the recommendations of CNGOF: what inventory? Gynecol Obstet Fertil. 2016;44:232–8. Competing interests 17. Collège National des Gynécologues et Obstétriciens Français. Text of the Author PS received funding from the following commercial companies: guidelines for episiotomy. J Gynecol Obstet Biol Reprod. 2006;35(1):7–135. Merck Serono, Finox Biotech, MSD France SAS, Teva Santé SAS, Allergan 18. Goueslard K, Revert M, Pierron A, Vuagnat A, Cottenet J, Benzenine E, et al. France, Gedeon Richter France, Effik S.A., Karl Storz Endoscopie France, GE Evaluation of the metrological quality of medico-administrative data for Medical Systems SCS, Laboratoires Genevrier, H.A.C. Pharma, and Ipsen. perinatal indicators: a pilot study. J Community Med Health Educ. 2016;6(3):1–6. Author PS confirms that none of this funding was used to support the 19. Quantin C, Cottenet J, Vuagnat A, Prunet C, Mouquet MC, Fresson J, et al. research in this study. The other authors declare that they have no Quality of perinatal statistics from hospital discharge data: comparison with competing interests. civil registration and the 2010 National Perinatal Survey. J Gynecol Obstet Biol Reprod (Paris). 2014;43(9):680–90. Publisher’sNote 20. Lesieur E, Blanc J, Loundou A, Dubuc M, Bretelle F. Can the rate of Springer Nature remains neutral with regard to jurisdictional claims in episiotomy still be lowered? Status update in PACA region (south of published maps and institutional affiliations. France). Gynecol Obstet Fertil Senol. 2017;45(3):146–51. 21. Macleod M, Strachan B, Bahl R, Howarth L, Goyder K, Van de Venne M. al. A Author details prospective cohort study of maternal and neonatal morbidity in relation to Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; use of episiotomy at operative vaginal delivery. BJOG. 2008;115:1688–94. Bourgogne Franche-Comté University, Dijon, France. Laboratoire interpsy 22. Chuilon AL, Le Ray C, Prunet C, Blondel B. Episiotomy in France in 2010: (EA4432), université de Lorraine, Nancy 2, 3, place Godeffroy-de-Bouillon, Variations according to obstetrical context and place of birth. J Gynecol 54000 Nancy, France. Centre hospitalier de Jury-les-Metz, route Obstet Biol Reprod (Paris) 2016;(45):691–700. d’Ars-Laquenexy, 57073 Jury-Les-Metz cedex 03, BP 75088 Nancy, France. 23. Ballesteros-Meseguer C, Carillo-Garcia C, Meseguer-de-Pedro M, Canteras-Jordana Gynecology Obstetrics Center, François-Mitterrand Hospital, 14, rue M, Martinez-Roche M. Episiotomy and its relationship to various clinical variables Paul-Gaffarel, 21000 Dijon, France. Inserm, CIC 1432, Dijon, France; Dijon that influence its performance. Rev Latino-Am Enfermagem. 2016;24:e2793. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 10 of 10 24. Lansac J, Crenn-Hebert C, Rivière O, Venditelli F. How singleton breech babies at term are born in France: a survey of data from the AUDIPOG network. Eur J Obstet Gynecol Reprod Biol. 2015;188:79–82. 25. Mangin M, Ramanah R, Aouar Z, Courtois L, Collin A. Cossa s, et al. operative delivery data in France for 2007: results of a national survey within teaching hospitals. J Gynecol Obstet Biol Reprod (Paris). 2010;39:121–32. 26. Reinbold D, Éboue C, Morello R, Lamendour N, Herlicoviez M, Dreyfus M. From the impact of French guidelines to reduce episiotomy’s rate. J Gynecol Obstet Biol Reprod (Paris). 2012;41:62–8. 27. Ginod P, Khallouk B, Benzenine E, Desplanches T, Dub T, Schmutz E, et al. Assessment of restrictive episiotomy use and impact on perineal tears in the Burgundy’s perinatal network. J Gynecol Obstet Biol Reprod (Paris). 2016;45:1165–71. 28. Blondel B, Alexander S, Bjarnadottir RI, Gissler M, Langhoff-Roos J, Novak-Antolic Z, et al. Variations in rates of severe perineal tears and episiotomies in 20 European countries: a study based on routine national data in Euro-Peristat project. Acta Obstet Gynecol Scand. 2016;95(7):746–54. 29. Clemons JL, Towers GD, McClure GB, O’Boyle AL. Decreased anal sphincter lacerations associated with restrictive episiotomy use. Am J Obstet Gynecol. 2005;192(5):1620. 30. Langer B, Minetti A. Immediate and long term complications of episiotomy. J Gynecol Obstet Biol Reprod (Paris). 2006;35(1):1S59–67. 31. Amorim MM, Franca-Neto A, Leal NV, Melo FO, Maia SB, Alves J. Is it possible to never perform episiotomy during vaginal delivery? Obstet Gynecol. 2014;123(1):38S. 32. Steiner N, Weintraub AY, Wiznitzer A, Sergienko R, Sheiner E. Episiotomy: the final cut? Arch Gynecol Obstet. 2012;286(6):1369–73. 33. Harvey MA, Pierce M, Alter JA, Chou Q, Diamond P, Epp A, et al. Obstetrical anal sphincter injuries (OASIS): prevention, recognition, and repair. J Obstet Gynaecol Can. 2015;37(12):1131–48. 34. Faruel-Fosse H, Vendittelli F. Can we reduce the episotomy rate? J Gynecol Obstet Biol Reprod (Paris). 2006;35(1):68–76. 35. Henriksen TB, Bek KM, Hedegaard M, Secher NJ. Methods and consequences in use of episiotomy. BMJ. 1994;309:1255–8. 36. Zhang-Rutledge K, Clark SL, Denning S, Timmins A, Dildy GA, Gandhi M. An initiative to reduce the episiotomy rate: Association of Feedback and the Hawthorne effect with leapfrog goals. Obstet Gynecol. 2017;30(1):146–50. 37. Althabe F, Buekens P, Bergel E, Belizan CMK, Moss N. A behavioral intervention to improve obstetrical care. N Engl J Med. 2008;358(18):1929–40. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Pregnancy and Childbirth Springer Journals

How did episiotomy rates change from 2007 to 2014? Population-based study in France

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Medicine & Public Health; Reproductive Medicine; Maternal and Child Health; Gynecology
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Abstract

Background: Since the 2000s, selective episiotomy has been systematically recommended worldwide. In France, the recommended episiotomy rate in vaginal deliveries is less than 30%. The aims of this study were to describe the evolution of episiotomy rates between 2007 and 2014, especially for vaginal deliveries without instrumental assistance and to assess individual characteristics and birth environment factors associated with episiotomy. Methods: This population-based study included all hospital discharge abstracts for all deliveries in France from 2007 to 2014. The use of episiotomy in vaginal deliveries was identified by one code in the French Common Classification of Medical Procedures. The episiotomy rate per department and its evolution is described from 2007 to 2014. A mixed model was used to assess associations with episiotomy for non-operative vaginal deliveries and the risk factors related to the women’s characteristics and the birth environment. Results: There were approximately 540,000 non-operative vaginal deliveries per year, in the study period. The national episiotomy rate for vaginal deliveries overall significantly decreased from 26.7% in 2007 to 19.9% in 2014. For non-operative deliveries, this rate fell from 21.1% to 14.1%. For the latter, the use of episiotomy was significantly associated with breech vaginal delivery (aOR = 1.27 [1.23–1.30]), epidural analgesia (aOR = 1.45 [1.43–1.47]), non-reassuring fetal heart rate (aOR = 1.47 [1.47–1.49]), and giving birth for the first time (aOR = 3.85 [3.84–4.00]). Conclusions: The episiotomy rate decreased throughout France, for vaginal deliveries overall and for non-operative vaginal deliveries. This decrease is probably due to proactive changes in practices to restrict the number of episiotomies, which should be performed only if beneficial to the mother and the infant. Keywords: Episiotomy, Birth, Vaginal deliveries, Hospital discharge abstracts Background from country to country. In Latin America from 1995 to Historically, episiotomy is a surgical incision of the vaginal 1998, the median episiotomy rate for primiparous women orifice performed to reduce severe perineal tears, per was 92.3% [5]. In 2000–2001, episiotomy rates were 23.8% partum fetal asphyxia during the fetal expulsion stage of in Canada and 32.7% in the United States while it was birth and subsequent urinary or fecal incontinence [1–3]. 100% in Taiwan in 2002. In Europe, the rates varied In the 1980s–1990s, episiotomy was routinely performed. widely: 9.7% in Sweden in 1999–2000, 12.0% in Denmark, In France, in 1998, the rate of episiotomy, usually medio- 13.0% in England, 44.4% in Germany in 2002–2003, and lateral, was 71.3% for primiparous women and 36.3% for 58.0% in Italy in 1999 [6]. multiparous women [4]. This rate varied considerably Since 1990, randomized controlled trials have ques- tioned the routine use of episiotomy, which does not * Correspondence: catherine.quantin@chu-dijon.fr seem to provide more benefits than a selective practice. Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; Indeed, restrictive episiotomy practice was associated Bourgogne Franche-Comté University, Dijon, France with a higher risk of anterior perineal trauma but not Inserm, CIC 1432, Dijon, France; Dijon University Hospital, Clinical Investigation Center, clinical epidemiology/ clinical trials unit, Dijon, France with perineal infection, moderate or severe pain, long- Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 2 of 10 term dyspareunia or long-term urinary incontinence, or gestational age (available only since 2010), multiple an Apgar score less than seven at five minutes in the new- pregnancy, epidural analgesia, non-reassuring fetal born child [3, 7–11]. Currently, selective episiotomy practice heart rate, breech vaginal delivery, newborn weight > is systematically recommended, and some authors and 4000 g (for single pregnancies, linkage with the birth policy statements state that episiotomy should be avoided abstract reliable only since 2013). We also considered if at all possible [10–13]. However, guidelines are relatively severe perineal tear: third degree (injury to the anal disparate regarding the most appropriate episiotomy rate. sphincter complex) and fourth degree (injury to the In 1992, Henriksen suggested an appropriate rate of 20% perineum involving the anal, or sphincter complex and [14]. In 1996, the World Health Organization recom- anal epithelium) [8]. Variables retained for the environ- mended a target rate of 10% [15]. Furthermore, the effective ment were the year of delivery, and department (French implementation of evidence-based healthcare practices regions are divided into geographical departments). remains a significant challenge. In 2005, as the episiotomy rate had already reached 41.3% [16], the French National Statistical analysis College of Gynecologists and Obstetricians recommended a The characteristics are presented as means or proportions. more restrictive practice based on « the clinical expertise of Percentages were compared using Pearson’s Chi 2 test or the physician », at less than 30% of vaginal deliveries [17]. Fisher’s exact test under the conditions of application. To To our knowledge, no studies have examined the recent evaluate trends in episiotomy rates between 2007 and trend in episiotomy rates in France as a whole even though 2014, we used the Cochran-Armitage test. the guidelines are about 12 years old. The aim of the Episiotomy rates in 2007 and 2014 are presented per present study was to describe the evolution of episiotomy department (97 departments, including overseas territories). rates from 2007 to 2014, especially for non-operative A mixed model was used to assess associations with vaginal deliveries. We also studied the clinical and birth risk factors. As the independence of the observations environment factors associated with episiotomy. could not be confirmed, hierarchical logistic regression, which took into account the hierarchical structure of Methods data, was performed using the individual maternal vari- In this population-based retrospective cohort study, we ables as level 1 data, and the hospital as level 2 data. included all hospital discharge abstracts for all deliveries in Multilevel analyses were performed using SAS 9.4. France from 2007 to 2014. Diagnoses were coded according Geographic Information System MapInfo 11.0 was used to the International Classification of Diseases (ICD-10) and for the cartography. procedures according to the French Common Classification This study was approved by the French Committee for of Medical Procedures (CCMP). Data Protection (Commission Nationale de l’Informatique et des Libertés, registration number 1576793) and was Population conducted in accordance with French legislation. Written All hospital discharge abstracts mentioning the codes consent was not needed for this study. The national Z37 (“outcome of delivery”) of the ICD-10 were selected. hospital database was transmitted by the national agency In France, Z37 codes are considered the most reliable for the management of hospitalization data (ATIH number and exhaustive to select hospital deliveries. All vaginal 2015–111111–47-33). deliveries were examined, but we especially focused on non-operative vaginal deliveries (the related codes are Results described in the Additional file 1). There were about 800,000 deliveries per year (minimum 790,994 in 2007 and maximum 815,396 in 2010). The Variables percentage of vaginal deliveries was very stable, ranging In the present study, the outcome of interest was episi- from 79.74% in 2007 to 79.59% in 2014. The proportion of otomy, which was defined by one code in the CCMP non-operative vaginal deliveries slightly decreased from 68. (JMPA006). The quality of hospital discharge abstracts 59% in 2007 to 67.57% in 2014. regarding episiotomy has been validated thanks to a French For all vaginal deliveries or for non-operative vaginal validation study [18]. Unfortunately, to our knowledge, no deliveries, the nationwide episiotomy rate significantly validity studies have used national data to study episiotomy decreased (p < 0.01) from 26.7% (21.1% for non-operative in non-operative vaginal deliveries. vaginal deliveries) in 2007 to 19.9% (respectively 14.1%) in The explanatory variables concerned the characteristics 2014. This was also the case for episiotomy rates in in- of the women and the characteristics of birth environment. strumental deliveries (61.0% in 2007 vs 52.6% in 2014, At the maternal level, we considered the known risks p <0.01). factors for episiotomy: maternal age, parity (primiparous Then, we focused on non-operative vaginal deliveries. women were women who gave birth for the first time), The characteristics of women are presented in Table 1. For Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 3 of 10 women who underwent non-operative vaginal deliveries, the difference in the total number of deliveries when the average maternal age was 29–30 years (+/− 5 years), compared with the national civil registry, which records slightly more than one third of women were primiparous all births in France, was only 0.3% [19]. The National womenand about 93% of womenhad givenbirth at 37 to Perinatal Survey in 2010 showed a vaginal delivery rate of 41 weeks of amenorrhea (2010–2014). 79.0% and a non-operative vaginal delivery rate of 66.9% For non-operative vaginal deliveries, Figs. 1 and 2 [4]. Our results were 79.4% for all vaginal deliveries and present the distribution of episiotomy rates per department 67.7% for non-operative vaginal deliveries. in 2007 and 2014, respectively. Inter-departmental disparity In 2012, at the individual level, a validation study was was as high in 2007 (ranging from 4.0% to 39.9%) as in performed to evaluate the metrological quality of hospital 2014 (ranging from 1.4% to 33.9%). The episiotomy rate discharge abstracts for perinatal indicators. The validity decreased by 25 to 75% from 2007 to 2014 for the majority study concerned the same data but only from three of geographic departments as shown in Fig. 3.The university hospitals which agreed to provide a comparison episiotomy rate, which was higher than 30% in 14 between hospital discharge abstracts and medical records. departments (about 15% of the 97 departments) in 2007, For vaginal deliveries, the positive predictive value (PPV) reached a high rate (33.9%) in only one department in was 99.5% [98.5–100] and the sensitivity (Se) was 100%. 2014. For episiotomy, irrespective of the vaginal mode of delivery, Regarding the rate of severe perineal tears (third and the PPV was 88.9% [79.7–98.1] and the Se was 90.9% fourth degree) for non-operative vaginal deliveries, we [82.4–99.4]. For perineal tears in vaginal deliveries, the observed a significant increase between 2007 and 2014, PPV was 94.3% [89.9–98.7] and the Se was 88.6% [82.8– for women with episiotomy (0.4 to 0.8%, p < 0.01) and 94.4] [18]. In France, no data from validation studies are without episiotomy (0.2 to 0.4%, p < 0.01). The distribu- available for severe perineal tears in cases of non- tion of severe perineal tears is presented in the Appendix operative vaginal deliveries. However, in 2010, the rate (Additional file 2). of severe perineal tears for vaginal deliveries was 0.6% in The results of the multilevel logistic regression analyses our study, while the rate was estimated at 0.8% ([0.6–0.9]) are shown in Table 2 for different periods, for non- in the National Perinatal Survey [4]. operative vaginal deliveries. From 2007 to 2014, singleton Moreover, our population-based study allowed us to pregnancy was associated with a decrease in the use of examine some groups like breech vaginal deliveries or episiotomy (adjusted Odds Ratio (aOR) = 0.74, Confidence multiple deliveries with large sub-populations. These interval 95% [0.72–0.76]), as was maternal age under national data also allowed us to take into account the 20 years (aOR = 0.89 [0.87–0.91]). Breech vaginal delivery effects of the health facility or the variability in hospital (aOR = 1.27 [1.23–1.30]), epidural analgesia (aOR = 1.45 medical practices as we included a specific level for [1.43–1.47]), non-reassuring fetal heart rate (aOR = 1.47 hospitals in our multilevel model (level 2 of the model). [1.47–1.49]), and giving birth for the first time (aOR = 3. The main limitation of this study was related to differ- 85 [3.84–4.00]) were significantly associated with a higher ences in coding practices. In the validation study in 2012, risk of episiotomy. In addition to the significant variables we examined divergent cases for the discussion. During mentioned above, we found that giving birth before interviews, we were able to discern that some physicians 41 weeks of amenorrhea (from 2010 to 2014) and newborn could seldom report the code for episiotomy in cases of weight lower than 4000 g (from 2013 to 2014) significantly delivery with instrumental assistance, considering that (p < 0.0001) decreased the risk of episiotomy. episiotomy is a classical part of this delivery procedure. As regards all vaginal deliveries, the results of the ana- For this reason, we decided to focus on non-operative lyses were similar (Additional file 3). vaginal deliveries. All tables and figures were restricted to these cases. The results for all vaginal deliveries are Discussion only given for information (Additional file 3), as we Over the last few years, the episiotomy rate significantly know that they may be underestimated. However, when decreased at national and departmental level. In 2014, an episiotomy is coded, this episiotomy is generally for non-operative vaginal deliveries, the national rate performed. and the rates for all of the geographic departments Our results are consistent with previous studies except one were below 30%. These results suggest that regarding factors associated with the use of episiotomy. the recommendations have been seriously taken into We retrieved the usual risk factors: primiparous women, account and that proactive changes in practices to restrict multiple pregnancies, breech vaginal deliveries, epidural the use of episiotomy have been implemented nationwide. analgesia, non-reassuring fetal heart rate, newborn weight > One of the strengths of our study was to include 4000 g [20–23]. In France, episiotomy is not systematically nearly all deliveries, thanks to national discharge abstract used in breech vaginal deliveries. Indeed, the episiotomy data, as almost all deliveries occur in hospitals in France: rate decreased from 57% in 1994 to 28.4% in 2009–2010 Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 4 of 10 Table 1 Characteristics of women who underwent non-operative vaginal deliveries 2007 2008 2009 2010 2011 2012 2013 2014 Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No Episiotomy No episiotomy episiotomy episiotomy episiotomy episiotomy episiotomy episiotomy episiotomy Maternal agel 29 +/− 530+/−529+/− 530+/−529+/− 530+/−529+/−530+/−529+/−530+/−529+/− 530+/−529+/− 530+/−529+/− 530+/− 5 (years) Primiparous 60.6 31.6 61.3 32 62.7 32.7 63.8 32.8 63.9 32.1 64.1 31.7 64.1 31.5 64,0 31.6 *£ women Multiple 1.1 0.8 1.1 0.8 1.1 0.7 1.1 0.8 1.1 0.8 1.1 0.8 1,0 0.8 1.1 0.8 pregnancies Breech vaginal 2.1 1.2 2.1 1.3 2.1 1.3 2.2 1.3 2.2 1.4 2.2 1.4 2.3 1.5 2.4 1.5 delivery Perineal tears 0.4 0.2 0.5 0.3 0.5 0.3 0.5 0.3 0.6 0.3 0.6 0.3 0.7 0.4 0.8 0.4 (third and fourth degrees) Gestational age < 37 WA£–– – 4.1 6.1 4 6.1 3.9 6.2 3.9 6.2 3.9 6.1 37–41 WA£–– – 95.1 93.3 95.1 93.2 95.2 93,0 95.2 93.1 95.2 93.2 > 41 WA£–– – 0.8 0.6 0.9 0.7 0.9 0.8 0.9 0.7 0.9 0.7 WA = weeks of amenorrhea, * Missing Data < 1,5% p < 0.01 Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 5 of 10 Fig. 1 Distribution of episiotomy rates for non-operative vaginal deliveries in 2007 [24]. Although the restrictive practice of episiotomy has our estimation (11.3%, all over the corresponding de- been established by evidence-based medicine, the indica- partment) but the 2009 study included only one hospital tions to perform episiotomy are still a matter of debate. and only single pregnancies and cephalic presentations In France, even though, to our knowledge, no national [26]. Another study based on Burgundy Perinatal Network rates have been published for all hospitals, some studies data showed similar results to ours in the four departments have been performed, and their results seem to agree included in this region [27]. A study conducted in the south with ours. A first study in 2007, which concerned vaginal of France reported a decrease in the rate of episiotomy deliveries in university hospitals, estimated a national (from 35.8% in 2003–2005 to 16.7% in 2012–2014) [20]. All episiotomy rate of 32.4%. It is not surprising that our es- these studies highlight a high disparity in episiotomy rates timation for vaginal deliveries in 2007 (26.7%) was lower not only between departments but also between hospitals. as we considered all hospital types [25]. In 2009, another In our study, a decrease in episiotomy rates was shown for study in one hospital estimated the episiotomy rate in the vast majority of French departments from 2007 to vaginal deliveries at 7.6%. This figure is slightly below 2014. Over the same period, severe perineal tears (third and Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 6 of 10 Fig. 2 Distribution of episiotomy rates for non-operative vaginal deliveries in 2014 fourth degrees) significantly increased in women who had does not stem from coding problems in hospital data. An- non-operative vaginal deliveries. These results were consist- other explanation could be non-diagnosis [33], which none- ent with those of the Euro-peristat project, which described theless seems to be diminishing over time. In fact, we an increase in the rate of severe perineal tears for all vaginal observed an increase in severe perineal tears in France deliveries between 2004 and 2010 in all European countries, which may be related to improvements in vigilance and except Germany and Norway [28]. This issue is still the the training of professionals in the diagnosis and sutur- subject of a controversial debate [7, 9, 20, 29–32]. Random- ing of these severe perineal tears which are responsible ized trials showed no increase in severe perineal tears re- for urinary and fecal incontinence [29]. lated to the restrictive use of episiotomy [3]. On the We can notice that, for non-operative vaginal deliveries, contrary our results showed that the restrictive practice of the rate decreased markedly in all departments (decrease episiotomy was associated with a greater risk of severe peri- of 25 to 75%), even when initial rates were about 30%. In neal tears. However, the rate in France is lower than the 2014, 14 of the 97 departments presented an episiotomy mean rate found in EURO-PERISTAT, which suggests that rate below 10% for non-operative vaginal deliveries. The the rate is under-estimated in France. Given that the rate rate of severe perineal tears was unavailable for two of these found in our study is in keeping with that found in the na- departments, between 0.15 and 0.58% for ten departments tional perinatal survey, it is likely that this under-estimation and above 1% for two departments. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 7 of 10 Fig. 3 Evolution of episiotomy rates for non-operative vaginal deliveries from 2007 to 2014 It seems difficult to define what could be the right obtained in 57% of French departments with a rate of se- episiotomy rate in France. The WHO recommended a vere perineal tears not more than 1%. As a consequence, target of 10% for episiotomy. This recommendation can- one could hypothesize than a rate of 15% could be not be generalized as it was based on a case-controlled reached by most departments in a reasonable time. Fur- study that included only non-induced labor for a single ther research is of course needed to confirm this pregnancy at over 37 weeks of amenorrhea. Moreover, it hypothesis. took into account the high infection rate in developing This target rate can be considered achievable for all countries, which is not the case in France. The restrict- French departments, though a national program is neces- ive practice of episiotomy must provide an episiotomy sary. A passive approach after the publication of guidelines rate that is optimal for children’s and mothers’ health is not enough and the implementation of evidence-based and ensure low rates of severe perineal tears, which are practices remains a real challenge. Previous publications very harmful for women. Our results suggest that a rate have shown that the impact of guidelines is greater if they below 15% for non-operative vaginal deliveries was are worked on with the teams concerned, particularly in Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 8 of 10 Table 2 Hierarchical logistic regressions, non-operative vaginal deliveries Episiotomy (2007–2014) Episiotomy (2010–2014) Episiotomy (2013–2014) aOR 95% CI aOR 95% CI aOR 95% CI Maternal age (ref ≥ 40 years) < 20 0.89 [0.87–0.91] 0.89 [0.86–0.92] 0.85 [0.81–0.90] 20–29 1.03 [1.01–1.05] 1.03 [0.99–1.04] 0.98 [0.94–1.02] 30–39 1.09 [1.07–1.12] 1.07 [1.05–1.09] 1.04 [1.01–1.08] aa Single pregnancy (ref = 0) 0.74 [0.72–0.76] 0.57 [0.55–0.59] Breech vaginal delivery (ref = 0) 1.27 [1.23–1.30] 1.45 [1.41–1.48] 1.59 [1.49–1.67] Epidural analgesia (ref = 0) 1.45 [1.43–1.47] 1.43 [1.43–1.45] 1.47 [1.45–1.52] Non-reassuring fetal heart rate (ref = 0) 1.47 [1.47–1.49] 1.49 [1.47–1.52] 1.49 [1.47–1.54] Status of health establishment (ref = Private) 1.33 [1.12–1.56] 1.30 [1.09–1.54] 1.37 [1.15–1.64] Year of delivery (ref = 2014) 2007 1.63 [1.61–1.64] aa a a 2008 1.58 [1.56–1.60] aa a a 2009 1.46 [1.44-1.48] aa 2010 1.37 [1.36-1.39] 1.37 [1.35–1.38] aa 2011 1.31 [1.29-1.32] 1.30 [1.29–1.32] aa 2012 1.21 [1.20-1.23] 1.21 [1.20–1.23] 2013 1.13 [1.12-1.15] 1.13 [1.12–1.15] 1.13 [1.11–1.14] Parity (ref = multiparous women) 3.85 [3.84–4.00] 4.00 [4.00–4.17] 4.17 [4.17–4.35] Gestational age (ref > 41 WA) bb < 37WA 0.42 [0.40-0.44] 0.42 [0.39–0.45] bb 37-41WA 0.82 [0.79-0.85] 0.82 [0.77–0.87] bb bb Newborn weight (ref < 4000 g) 1.54 [1.49-1.56] aOR: Adjusted Odds ratio, CI: Confidence Interval, WA: Weeks of Amenorrhea Not studied Not available in database Only single pregnancy obstetrics [34]. At the national level, a community of practitioners, gain their support in implementing a re- practices could promote the dissemination of experience, strictive practice policy for episiotomy. Perinatal networks and thus decrease the episiotomy rate without increasing havearole toplayinstandardizing therestrictive useof severe perineal tears. episiotomy in the areas they cover. Our study suggests that the action plan should now be looking at the individual level. Some authors have described how a private and confidential feedback from Conclusions physicians about their own practices can induce a Our study described the evolution of episiotomy rates in decrease in the use of episiotomy [35, 36]. Ambassadors France following the recommendations of the National with communication and training skills may effectively College of Gynecologists and Obstetricians. We showed that facilitate changes in their teams [37]. In the same way, the use of episiotomy in non-operative vaginal deliveries fell audits, risk management approaches, continuous care significantly from 21.1% in 2007 to 14.1% in 2014 at the na- quality improvement programs and the understanding of tional and departmental level. However, at the departmental professionals’ behavior with regard to perineum protection level, theepisiotomyrates stillrangedfrom1.4%to33.9%. should lead to the standardization of good practices for To reduce the still present disparities without impairing the selective episiotomy. health of women and their children, it is necessary to act at The continuous training of physicians and midwives is the individual level and to encourage every professional to an important lever to improve quality of care. Perinatal think about his/her use of episiotomy in the light of clear, networks, which aim to inform, train and motivate relevant indicators. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 9 of 10 Additional files University Hospital, Clinical Investigation Center, clinical epidemiology/ clinical trials unit, Dijon, France. Inserm, CIC 1432, Dijon, France ; Dijon University Hospital, Clinical Investigation Center, clinical epidemiology/ Additional file 1: ICD-10 codes and CCMP codes. Description of codes clinical trials unit, Dijon, France. used for identification of delivery modes and risk factors. (DOCX 14 kb) Additional file 2: Figure: Distribution of severe perineal tears rates for Received: 1 August 2017 Accepted: 19 April 2018 non-operative vaginal deliveries in 2014. The figure presents the rate of severe perineal tears per department, in 2014, in France. (DOCX 246 kb) Additional file 3: Table: Hierarchical logistic regressions, all vaginal References deliveries. The table presents the association between the episiotomy 1. Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative and risk factors, for all vaginal deliveries. (DOCX 18 kb) review of the english language literature, 1860–1980. Obstet Gynecol Surv. 1983;38:322–38. 2. Cunningham FG. Conduct of normal labor and delivery. In: Cunningham FG, Abbreviations MacDonald PC, Gant NF, Leveno KJ, Gilstrap LCIII, editors. Williams aOR: Adjusted Odds Ratio; CCMP: Common Classification of Medical obstetrics. 19th edition. Appleton and Lange; Norwalk, CT; 1993. p. 371–93. Procedures; CI: Confidence Interval; ICD-10: International Classification of 3. Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database Syst Diseases-version10; PPV: Positive Predictive Value; Se: Sensitivity; WA: Weeks Rev. 2009;1:CD000081. of Amenorrhea 4. Blondel B, Lelong N, Kermarrec M, Goffinet F. Trends in perinatal health in France between 1995 and 2010: results from the national perinatal surveys. Acknowledgements J Gynecol ObstetBiol Reprod (Paris). 2012;41:151–66. The authors thank Philip Bastable for reviewing the English. 5. Althabe F, Belizan JM, bergel E. Episiotomy rates in primiparous women in Latin America: hospital based descriptive study. BMJ. 2002;324(7343):945–6. Funding 6. Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the This research did not receive any specific grant from funding agencies in the world: an update. Birth. 2005;32(3):219–23. public, commercial, or not-for-profit sectors. 7. Argentine episiotomy trial collaborative group. Routine vs selective episiotomy: a randomised controlled trial. Lancet. 1993;342:1517–8. Availability of data and materials 8. Dannecker C, Hillemanns P, Strauss A, Hasbargen U, Hepp H, Anthuber C. The hospital database was transmitted by the national agency for the Episiotomy and perineal tears presumed to be imminent: randomized management of hospitalization data. The use of these data by our controlled trial. Acta Obstet Gynecol Scand. 2004;83:364–8. department was approved by the National Committee for data protection. 9. Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of The French Committee for Data Protection who approved our study did not episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017;2:CD000081. approve the sharing of raw data. 10. American College of Obstetricians-Gynecologists. ACOG practice bulletin. Episiotomy. Clinical management guidelines for obstetrician-gynecologists. Authors’ contributions Number 71, April 2006. Obstet Gynecol. 2006;107(4):957–62. KG, JC conceptualized and designed the study, interpreted the data and 11. Berghella V, Baxter JK, Chauhan SP. Evidence-based labor and delivery wrote the paper. AR conducted the cartographical analysis, and contributed management. Am J Obstet Gynecol. 2008;199:445–54. substantially to writing the manuscript. CC, PS participated in the 12. Cargill Y, MacKinnon C. The clinical practice obstetrics committee. Guidelines interpretation of the results reviewed and revised the manuscript drafts. CQ for operative vaginal birth. J Obstet Gynaecol Can. 2004;26(8):747–53. oversaw the data analysis and interpretation, and contributed substantially to 13. National Collaborating Centre for Women’s and Children’s Health. writing the manuscript. All authors accept responsibility for the paper as Intrapartum care: care of healthy women and their babies during childbirth. published. All authors read and approved the final manuscript. In: RCOG press; 2017. 14. Henriksen TB, Bek KM, Hedegaard M, Secher NJ. Episiotomy and perineal lesions Ethics approval and consent to participate in spontaneous vaginal deliveries. Br J Obstet Gynaecol. 1992;(12):950–4. This study was approved by the French Committee for data protection 15. World Health Organization, Department of Reproductive Health and (registration number 1576793) and therefore was conducted in accordance with Research. Care in normal birth: a practical guide. 1996. WHO/FRH/MSM/96. the Declaration of Helsinki. Written consent was not needed for this study. The 24 Available at http://apps.who.int/iris/bitstream/10665/63167/1/WHO_FRH_ hospital database was transmitted by the national agency for the management MSM_96.24.pdf of hospitalization data (ATIH, registration number 2015–111111–47-33). Written 16. Clesse C, Lighezzolo-Alnot J, Hamlin S, De Lavergne S, Scheffler M. The consent was not needed for this study. practice of episiotomy in France 10 years after the recommendations of CNGOF: what inventory? Gynecol Obstet Fertil. 2016;44:232–8. Competing interests 17. Collège National des Gynécologues et Obstétriciens Français. Text of the Author PS received funding from the following commercial companies: guidelines for episiotomy. J Gynecol Obstet Biol Reprod. 2006;35(1):7–135. Merck Serono, Finox Biotech, MSD France SAS, Teva Santé SAS, Allergan 18. Goueslard K, Revert M, Pierron A, Vuagnat A, Cottenet J, Benzenine E, et al. France, Gedeon Richter France, Effik S.A., Karl Storz Endoscopie France, GE Evaluation of the metrological quality of medico-administrative data for Medical Systems SCS, Laboratoires Genevrier, H.A.C. Pharma, and Ipsen. perinatal indicators: a pilot study. J Community Med Health Educ. 2016;6(3):1–6. Author PS confirms that none of this funding was used to support the 19. Quantin C, Cottenet J, Vuagnat A, Prunet C, Mouquet MC, Fresson J, et al. research in this study. The other authors declare that they have no Quality of perinatal statistics from hospital discharge data: comparison with competing interests. civil registration and the 2010 National Perinatal Survey. J Gynecol Obstet Biol Reprod (Paris). 2014;43(9):680–90. Publisher’sNote 20. Lesieur E, Blanc J, Loundou A, Dubuc M, Bretelle F. Can the rate of Springer Nature remains neutral with regard to jurisdictional claims in episiotomy still be lowered? Status update in PACA region (south of published maps and institutional affiliations. France). Gynecol Obstet Fertil Senol. 2017;45(3):146–51. 21. Macleod M, Strachan B, Bahl R, Howarth L, Goyder K, Van de Venne M. al. A Author details prospective cohort study of maternal and neonatal morbidity in relation to Biostatistics and Bioinformatics (DIM), University Hospital, Dijon, France; use of episiotomy at operative vaginal delivery. BJOG. 2008;115:1688–94. Bourgogne Franche-Comté University, Dijon, France. Laboratoire interpsy 22. Chuilon AL, Le Ray C, Prunet C, Blondel B. Episiotomy in France in 2010: (EA4432), université de Lorraine, Nancy 2, 3, place Godeffroy-de-Bouillon, Variations according to obstetrical context and place of birth. J Gynecol 54000 Nancy, France. Centre hospitalier de Jury-les-Metz, route Obstet Biol Reprod (Paris) 2016;(45):691–700. d’Ars-Laquenexy, 57073 Jury-Les-Metz cedex 03, BP 75088 Nancy, France. 23. Ballesteros-Meseguer C, Carillo-Garcia C, Meseguer-de-Pedro M, Canteras-Jordana Gynecology Obstetrics Center, François-Mitterrand Hospital, 14, rue M, Martinez-Roche M. Episiotomy and its relationship to various clinical variables Paul-Gaffarel, 21000 Dijon, France. Inserm, CIC 1432, Dijon, France; Dijon that influence its performance. Rev Latino-Am Enfermagem. 2016;24:e2793. Goueslard et al. BMC Pregnancy and Childbirth (2018) 18:208 Page 10 of 10 24. Lansac J, Crenn-Hebert C, Rivière O, Venditelli F. How singleton breech babies at term are born in France: a survey of data from the AUDIPOG network. Eur J Obstet Gynecol Reprod Biol. 2015;188:79–82. 25. Mangin M, Ramanah R, Aouar Z, Courtois L, Collin A. Cossa s, et al. operative delivery data in France for 2007: results of a national survey within teaching hospitals. J Gynecol Obstet Biol Reprod (Paris). 2010;39:121–32. 26. Reinbold D, Éboue C, Morello R, Lamendour N, Herlicoviez M, Dreyfus M. From the impact of French guidelines to reduce episiotomy’s rate. J Gynecol Obstet Biol Reprod (Paris). 2012;41:62–8. 27. Ginod P, Khallouk B, Benzenine E, Desplanches T, Dub T, Schmutz E, et al. Assessment of restrictive episiotomy use and impact on perineal tears in the Burgundy’s perinatal network. J Gynecol Obstet Biol Reprod (Paris). 2016;45:1165–71. 28. Blondel B, Alexander S, Bjarnadottir RI, Gissler M, Langhoff-Roos J, Novak-Antolic Z, et al. Variations in rates of severe perineal tears and episiotomies in 20 European countries: a study based on routine national data in Euro-Peristat project. Acta Obstet Gynecol Scand. 2016;95(7):746–54. 29. Clemons JL, Towers GD, McClure GB, O’Boyle AL. Decreased anal sphincter lacerations associated with restrictive episiotomy use. Am J Obstet Gynecol. 2005;192(5):1620. 30. Langer B, Minetti A. 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An initiative to reduce the episiotomy rate: Association of Feedback and the Hawthorne effect with leapfrog goals. Obstet Gynecol. 2017;30(1):146–50. 37. Althabe F, Buekens P, Bergel E, Belizan CMK, Moss N. A behavioral intervention to improve obstetrical care. N Engl J Med. 2008;358(18):1929–40.

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BMC Pregnancy and ChildbirthSpringer Journals

Published: Jun 4, 2018

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