Layout 1 Mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 Pelvic Floor Disorders (PFDs) are a group of disorders related to the female genital area. PFDs can include Urinary Incontinence (UI) and Pelvic Organ Prolapse (POP).1 According to published statistics, approximately 338,000 surgeries are performed annually on patients with PFDs. Various factors are involved in the occurrence of PFDs and POP. One of the main factors is vaginal delivery.1,2 For successful vaginal delivery, gradual dilation of both the vagina and cervix is required, and tissues must be stretched properly. During this process, spontaneous peri- neal tears may arise with rapid fetal descent, particularly during the descent of the fetal head and the consequent vaginal distension. Another etiology of vaginal lacerations during childbirth is controlled and properly performed perineal incisions at the culmination of the second stage of labor, aimed at facilitating delivery through increasing the vaginal diameter; this procedure is clinically termed epi- siotomy.3-5 Despite the widespread practice of episiotomy, standardization in its application and repair is currently lacking. Research to date has not identified factors in- fluencing healing and long-term consequences, particularly concerning the efficacy of episiotomy in preventing future PFDs. Initially introduced in 1921 for fetal and maternal protection, episiotomy, specifically the mediolateral type in first-time mothers, was believed to offer advantages over spontaneous tears. These perceived benefits included easier repair, reduced short-term risk of severe lacerations, and protection against long-term pelvic floor dysfunction, as well as neonatal advantages such as decreased birth-related Abstract Pelvic Floor Disorders (PFDs) are a group of disorders of the female reproductive system that can cause a variety of problems for women. PFDs can include Urinary Incontinence (UI) and Pelvic Organ Prolapse (POP). This study evaluated the association between mediolateral episiotomy during pregnancy and POP in patients. A cross-sectional study with prospective follow-up was conducted on 150 pregnant women admitted for vaginal delivery at Furqani Hospital in Qom, Iran. Participants were divided into episiotomy and non-episiotomy groups based on clinical indications. Pelvic organ prolapse was assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system at baseline and 3-6 months postpartum. Data were analyzed using SPSS version 26, with a significance level of 0.05. The study included 142 patients with a mean age of 29.67 years. No significant differences were observed in demographic or clinical variables between the episiotomy and non-episiotomy groups at baseline. Postpartum, the episiotomy group showed significant improvements in cystocele severity (P=0.038), rectocele severity (P=0.026), apical prolapse (P=0.011), levator tone (P=0.016), and perineal descent (P=0.016). However, the cough test results did not differ significantly (P=0.052). Mediolateral episiotomy during vaginal delivery was associated with reduced severity of POP and improved PFD. These findings suggest a potential protective effect of episiotomy against certain pelvic floor complications, although further studies with larger sample sizes and longer follow-up periods are needed to confirm these results. Key Words: episiotomy, pelvic organ prolapse, vaginal delivery, pregnancy. Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 Study of the relationship between mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Marzieh Savari,1 Mahdieh Rahmatipanah,2 Sepideh Miraj,3 Abolfazl Mohammadbeigi4 1Department of Gynecology and Obstetrics, Shahed University Faculty of Medical Sciences, Tehran, Iran; 2Department of Obstetrics and Gynecology, Qom Medical Sciences, Qom, Iran; 3Department of Obstetrics and Gynecology, School of Medicine, Nekouei-Hedayati-Forghani Hospital, Qom University of Medical Sciences, Qom, Iran; 4Department of Biostatistics and Epidemiology, School of Health, Research Center for Environmental Pollutants, Qom University of Medical Sciences, Qom, Iran. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License (CC BY-NC 4.0) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. - 200 - Mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 trauma. Consequently, episiotomy became increasingly prevalent until the mid-20th century and was liberally per- formed until the late 1980s under the assumption that it prevented perineal overextension and subsequent pelvic floor weakness.6 However, subsequent randomized con- trolled trials have demonstrated that episiotomy fails to de- liver the maternal and neonatal benefits purported by its proponents.7,8 Furthermore, it has been shown to expose patients to an elevated risk of perineal body injury and anal sphincter damage.9 Indeed, during the latter half of the twentieth century, a growing body of evidence began to surface, indicating that episiotomy did not, in fact, confer these advantages.10 Subsequently, Thacker and Banta con- ducted a review of pertinent studies undertaken between 1860 and 1980, analyzing the findings to ascertain whether episiotomy provided any demonstrable benefits. Con- sequently, they reported that the available body of research was insufficient, and the studies lacked adequate method- ological rigor to conclusively validate their hypotheses. Therefore, the findings did not support the routine utiliza- tion of episiotomy. Furthermore, postpartum pain and dis- comfort were evident and represented significant complications, with maternal mortality, albeit rare, also identified as a potential consequence of episiotomy. In re- sponse to mounting concerns and evidence, the American College of Obstetricians and Gynecologists (ACOG) sub- sequently recommended the selective use of episiotomy in carefully selected patients. The impact of episiotomy on Pelvic Floor (PF) function has been investigated in several questionnaire-based studies.11 A meta-analysis, synthesiz- ing the findings of these studies, reported that episiotomy was not associated with a decreased risk of pelvic floor dysfunction-related complaints, including UI, fecal incon- tinence or flatus incontinence, and sexual dysfunction.12 The use of vaginal delivery has fewer complications for mothers compared to cesarean section. However, vaginal delivery has been shown to be a factor in the occurrence of POP in patients. However, the relationship between me- diolateral episiotomy during vaginal delivery and the oc- currence of POP in pregnant women has been limited, so we investigated this issue in this study. Materials and Methods Ethical subject and collected inform consent This study employed a cross-sectional design with a pro- spective follow-up component. The 150 patients were ran- domly selected from the patient population in Qom City. Following protocol approval by the Faculty of Medicine Research Council and ethical clearance (ethics code IR.MUQ.REC.1402.045) from the Research Ethics Com- mittee of Qom University of Medical Sciences, and after coordination with the hospital and obtaining consent from the medical staff, data collection commenced. Inclusion and exclusion criteria Inclusion criteria encompassed all pregnant mothers ad- mitted to Furqani Hospital who were eligible for vaginal delivery and provided informed consent to participate. Mothers who declined participation or underwent cesarean delivery based on physician discretion were excluded from the study. Procedure At baseline, researchers examined all mothers for POP using the Pelvic Organ Prolapse Quantification (POP-Q) system and recorded the Aa, Ba, Ap, Bp, D, C points, Total Vaginal Length (TVL), genital hiatus, and perineal body measurements. Subsequently, during the follow-up phase (3 to 6 months postpartum), mothers who had vaginal de- liveries were re-evaluated using POP-Q, and the aforemen- tioned parameters were remeasured. The allocation of mothers into episiotomy and non-episiotomy groups was not randomized. The decision to perform episiotomy was based on the gynecologist’s clinical judgment and was se- lective. Mothers with clinical indications for episiotomy during vaginal delivery received an episiotomy, while others delivered without episiotomy. The researchers had no intervention in the episiotomy decision-making process. Statistical analysis The sample size calculation, considering an anticipated cor- relation coefficient (R) of 0.24 between episiotomy and pel- vic organ prolapse, a statistical power of 80%, and a 95% confidence interval, determined a minimum required sam- ple size of 135 participants. Finally, the data collected from both time points (baseline and follow-up) were entered into SPSS software version 26 and subjected to analysis and comparison. It is important to note that no additional costs were incurred by patients during the study, and written in- formed consent was obtained from all participants. The sta- tistical significance level was set at 0.05. Results Description data of patients Table 1 compared various demographic and clinical factors between women who underwent episiotomy and those who did not. The mean age of participants was similar in both groups (29.4±2.6 vs. 29.8±2.5, p=0.401), indicating no sig- nificant difference in age distribution. Similarly, BMI showed a trend toward higher values in the non-episiotomy group (26.3±1.8 vs. 27.05±2.1, p=0.068), though this did not reach statistical significance. Gravidity and parity were also comparable between the two groups (Gravidity: 2.28±1.1 vs. 2.36±1.1, p=0.608; Parity: 1.1 vs. 0.9, p=0.665), suggesting no significant differences in obstetric history. The prevalence of addiction was low and did not differ significantly between groups (1.4% vs. 2.1%, p=0.771). The presence of underlying diseases was slightly higher in the episiotomy group (7.7% vs. 7.7%, p=0.055), though this difference was not statistically significant. Eth- nicity (Iranian vs. non-Iranian) and neonatal gender (boy vs. girl) also showed no significant differences between the groups (p=0.578 for both). Finally, neonatal weight was nearly identical in both groups (3266.7±91.8 vs. 3271.9±90.4, p=0.748), indicating no significant difference in birth weight. - 201 - Mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 Association between pelvic floor characteristics and pre-episiotomy The study evaluated pelvic floor characteristics and their association with episiotomy, based on pre-episiotomy as- sessments. The severity of cystocele showed no signifi- cant difference between the episiotomy and non-episiotomy groups, with the majority of cases classi- fied as Stage 1 (27 vs. 63, p=0.771) and Stage 2 (19 vs. 32), while Stage 3 was rare (0 vs. 1). Similarly, the severity of rectocele did not differ significantly, with most cases being Stage 1 (30 vs. 67, p=0.584) and Stage 2 (16 vs. 29). Apical prolapse also showed no significant variation, with Stage 1 being the most common (34 vs. 76, p=0.483) and Stage 2 less frequent (12 vs. 20). Levator tone was pre- dominantly moderate in both groups (29 vs. 62, p=0.862), with severe tone observed in a smaller proportion (16 vs. 33) and mild tone being rare (1 vs. 1). The cough test re- sults were similar, with no significant difference in posi- tive (8 vs. 20, p=0.629) or negative (38 vs. 76) outcomes. Perineal descent was also comparable, with no significant difference in positive (10 vs. 11, p=0.547) or negative (36 vs. 85) findings (Table 2). Association between pelvic floor characteristics and post-episiotomy The findings in Table 3 indicate that episiotomy is signifi- cantly associated with the severity of cystocele (P=0.038) and rectocele (P=0.026), with more advanced stages of cys- tocele and rectocele being more prevalent in patients with- out episiotomy. Additionally, episiotomy was also linked to the severity of apical prolapse (P=0.011) and reduced le- vator muscle tone (P=0.016). The results of the cough test (P=0.052) and perineal descent (P=0.016) also showed dif- ferences between the two groups, although the association with the cough test was not statistically significant at the 0.05 level. Overall, these findings suggest that episiotomy may be associated with a reduction in some pelvic prolapse- related complications after childbirth, but further studies are needed to confirm these results. Discussion A total of 142 patients were examined, with a mean age of 29.67 years, a mean BMI of 26.83, and a mean neonatal weight of 3270.28 grams. Additionally, the mean gravidity and parity of the studied patients were 2.33 and 1.06, re- spectively. The analysis of the mean values of quantitative variables (age, BMI, gravidity, parity, neonatal weight) and background variables (tobacco use, underlying med- ical conditions, ethnicity, neonatal sex) revealed no statis- tically significant differences between the two groups of mothers with and without episiotomy. Furthermore, the severity of cystocele, rectocele, and apical vaginal pro- lapse before episiotomy was also compared among the pa- tients, and no statistically significant differences were found between the two groups. However, after episiotomy, all three variables—cystocele severity, rectocele severity, and apical vaginal prolapse—showed statistically signif- icant differences. Regarding levator tone, cough test, and perineal descent, no significant differences were observed between the two groups before episiotomy. However, after episiotomy, both levator tone and perineal descent showed - 202 - Table 1. Comparative analysis of demographic and clinical factors in women with and without episiotomy. Episiotomy P value Yes No Age 29.4±2.6 29.8±2.5 0.401 BMI 26.3±1.8 27.05±2.1 0.068 Gravid 2.28±1.1 2.36±1.1 0.608 Parity 0.9 1.04±0.8 0.665 Addiction Yes 2 (1.4) 3 (2.1) 0.771 No 44 (31) 93 (65.5) Underlying disease Yes 11 (7.7) 11 (7.7) 0.055 No 35 (24.6) 85 (59.9) Race Iranian 36 (25.4) 71 (50) 0.578 Non Iranian 10 (7) 25 (17.1) Gender (neonate) Boy 19 (13.4) 38 (26.8) 0.578 Girl 27 (19) 58 (40.8) Weight (neonate) 3266.7±91.8 3271.9±90.4 0.748 Mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 statistically significant differences. Specifically, the sev- erity of levator tone and the incidence of perineal descent were significantly reduced in mothers who underwent epi- siotomy. Although there was a difference in the results of the cough test between the two groups, this difference was not statistically significant. In total, no internal or external studies were found that were entirely similar to the present study. Among the strengths of the current study is its meth- odology, wherein the researchers not only evaluated pelvic prolapse indicators before and after episiotomy but also - 203 - Table 2. Pre-episiotomy pelvic floor characteristics: a comparative analysis of women with and without episiotomy. Episiotomy P value Yes No Severity of cystocele Stage 1 27 63 0.771 Stage 2 19 32 Stage 3 0 1 Severity of Rectocele Stage 1 30 67 0.584 Stage 2 16 29 Apical prolapse Stage 1 34 76 0.483 Stage 2 12 20 Levator tone Mild 1 1 0.862 Moderate 29 62 Severe 16 33 Cough test Pos 8 20 0.629 Neg 38 76 Perineal descent Pos 10 11 0.547 Neg 36 85 Table 3. Post-episiotomy pelvic floor characteristics: a comparative analysis of women with and without episiotomy. Episiotomy P value Yes No Severity of cystocele Stage 1 41 74 0.038 Stage 2 5 25 Stage 3 0 1 Severity of Rectocele Stage 1 40 60 0.026 Stage 2 6 29 Apical prolapse Stage 1 44 76 0.011 Stage 2 2 20 Levator tone Mild 5 1 0.016 Moderate 30 62 Severe 11 33 Cough test Pos 4 21 0.052 Neg 42 75 Perineal descent Pos 1 4 0.016 Neg 45 92 Mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 included a control group for comparative analysis between the case and control groups. This aspect is a notable strength of the present study, as it was not observed in other similar studies. As for the limitations, the follow-up period of 3 to 6 months postpartum for reassessing pelvic prolapse indicators could be considered a weakness. Ex- tending this duration to evaluate the long-term outcomes of these indicators would be beneficial. Additionally, fu- ture studies with larger sample sizes could investigate pel- vic prolapse indicators alongside complications of vaginal delivery, such as urinary and anal incontinence, which was not feasible in the current study. Nevertheless, the follow- ing section will review and compare the results of the studies most closely related to the present one. In a similar study, Hakan Aytan and colleagues reported that episio- tomy had an impact on certain POP-Q indicators but did not affect the overall POP-Q stage.13 In our study, it was also found that episiotomy positively influenced POP-Q indicators, and this effect was significantly higher com- pared to the group without episiotomy. In another study, Frigerio and colleagues stated that they found no evidence of a long-term beneficial effect of episiotomy in prevent- ing urinary incontinence symptoms or anti-incontinence surgery. It does not appear that episiotomy negatively af- fects the development of genital prolapse and may even offer protection against the severity and prevalence of pro- lapse without influencing surgical rates.14 However, in our study, episiotomy led to an improvement in pelvic pro- lapse symptoms, which contrasts with the findings of Mat- teo Frigerio’s study. This discrepancy could be due to various reasons, such as differences in sample size, geo- graphical location, study design, and other factors. In yet another study, Bülent Doğan and colleagues concluded that vaginal delivery with mediolateral episiotomy was not associated with an increase in pelvic prolapse symp- toms.15 The findings of our study not only did not indicate an increase in pelvic prolapse symptoms in the episiotomy group but also revealed that the pelvic prolapse indicators were significantly better, statistically, in the group that un- derwent episiotomy compared to the group without epi- siotomy. This aligns with the findings of Bülent Doğan’s study. In another study, Sartore, Andrea, and colleagues concluded that mediolateral episiotomy does not protect against urinary and anal incontinence or genital prolapse and, compared to spontaneous perineal tears, is more frequently associated with dyspareunia, perineal pain, and lower pelvic floor muscle strength.7 In our study, postpar- tum incontinence in women was not examined, but the pelvic prolapse indicators were significantly better in the group that underwent episiotomy compared to the group that did not. It seems that this discrepancy between our re- sults and those of Sartore, Andrea could be due to differ- ences in sample size, study location, or the use of different diagnostic tools. This study has a number of limitations and strengths. This study was cross-sectional and the assessment was con- ducted on patients and, unlike previous studies, was not retrospective. It is better to conduct a study on a larger sta- tistical population in future studies. Also, the incidence of POP should be evaluated based on the age of the patients. Conclusions Ultimately, the results of this project indicated that medio- lateral episiotomy in vaginal delivery is associated with pel- vic organ prolapse in pregnant women and contributes to a reduction in these complications postpartum. However, there remains a divergence of opinion regarding the positive impact of episiotomy on pelvic organ prolapse. Given the conflicting findings across multiple studies, it is still unclear whether episiotomy has a long-term effect on pelvic floor relaxation and pelvic organ descent. Conflict of interest The authors declare no potential conflict of interest, and all authors confirm accuracy. Ethics approval and consent to participate All the procedures performed in the study involving human participants were in accordance with ethical standards of the local ethics committee of Qom University of Medical Sciences (IR.MUQ.REC.1402.045), as well as 1964 Hel- sinki declaration. Availability of data and materials All data generated or analyzed during this study are in- cluded in this published article. Acknowledgements The authors appreciate and thank the efforts of the Center for the Development of Clinical Researches of the Educa- tional and Therapeutic Research Complex of Qom Univer- sity of medical science. Corresponding author Sepideh Miraj, Associate Professor of Infertility & IVF, Department of Obstetrics and Gynecology, School of Medicine, Nekouei-Hedayati-Forghani Hospital, Qom University of Medical Sciences, Qom, Iran. ORCID ID: 0000-0002-0012-4527 E-mail: miraj.sepideh@gmail.com Co-authors Marzieh Savari ORCID ID: 0000-0002-5301-2588 E-mail: savari.marzieh@gmail.com Mahdieh Rahmatipanah ORCID ID: 0009-0003-0950-4969 E-mail: mahdie.rahmati20@icloud.com Abolfazl Mohammadbeigi ORCID ID: 0000-0002-3142-6413 E-mail: a.Mohammadbeigi@yahoo.com - 204 - https://orcid.org/0000-0002-0012-4527 mailto:miraj.sepideh@gmail.com mailto:savari.marzieh@gmail.com mailto:mahdie.rahmati20@icloud.com mailto:a.Mohammadbeigi@yahoo.com Mediolateral episiotomy in vaginal delivery and pelvic organ prolapse in pregnant mothers Eur J Transl Myol 35 (2) 13822, 2025 doi: 10.4081/ejtm.2025.13822 References 1. Good MM, Solomon ER. Pelvic floor disorders. Obst Gynecol Clinics 2019;46:527-40. 2. Gonzalez DC, Khorsandi S, Mathew M, Enemchukwu E, Syan R. A systematic review of racial/ethnic dispar- ities in female pelvic floor disorders. Urology 2022;163: 8-15. 3. Kettle C, Dowswell T, Ismail KM. Continuous and in- terrupted suturing techniques for repair of episiotomy or second-degree tears. Cochrane Database Syst Rev 2012;11:CD000947. 4. Azimi S, Modarres SZ, Esgandari M, Fahimi SA, Fazeli R. Evaluation of the effect of embryo transfer methods on pregnancy outcomes: a retrospective study and fu- ture perspectives. J Reproduct Infertil 2024;25:140. 5. Massoudifar A, Alimi N, Boostan A, et al. Investigating the relationship between the perception of labor pain and the number of deliveries. J Obstet Gynecol Cancer Res 2023;8:549-55. 6. Klein MC, Kaczorowski J, Robbins JM, et al. Physi- cians’ beliefs and behaviour during a randomized con- trolled trial of episiotomy: consequences for women in their care. Canadian Med Assoc J 1995;153:769. 7. Sartore A, De Seta F, Maso G, et al. The effects of me- diolateral episiotomy on pelvic floor function after vag- inal delivery. Obstet Gynecol 2004;103:669-73. 8. Woolley RJ. Benefits and risks of episiotomy: a review of the English-language literature since 1980. Part I. Obstet Gynecol Surv 1995;50:806-20. 9. Aytan H, Tapisiz OL, Tuncay G, Avsar FA. Severe peri- neal lacerations in nulliparous women and episiotomy type. Eur J Obstet Gynecol Reproduct Biol 2005;121: 46-50. 10. Thacker SB, Banta HD. Benefits and risks of episio- tomy: an interpretative review of the English language literature, 1860–1980. Obstet Gynecol Survey 1983;38: 322-38. 11. Klein MC, Gauthier RJ, Robbins JM, et al. Relationship of episiotomy to perineal trauma and morbidity, sexual dysfunction, and pelvic floor relaxation. Am J Obstet Gynecol 1994;171:591-8. 12. Hartmann K, Viswanathan M, Palmieri R, et al. Out- comes of routine episiotomy: a systematic review. JAMA 2005;293:2141-8. 13. Aytan H, Tok EC, Ertunc D, Yasa O. The effect of epi- siotomy on pelvic organ prolapse assessed by pelvic organ prolapse quantification system. Eur J Obstet Gynecol Reproduct Biol 2014;173:34-7. 14. Frigerio M, Mastrolia SA, Spelzini F, et al. Long-term effects of episiotomy on urinary incontinence and pelvic organ prolapse: a systematic review. Arch Gynecol Ob- stet 2019;299:317-25. 15. Doğan B, Gün İ, Özdamar Ö, Yılmaz A, Muhçu M. Long-term impacts of vaginal birth with mediolateral episiotomy on sexual and pelvic dysfunction and peri- neal pain. Jo Maternal-Fetal Neonat Med 2017;30: 457-60. Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their af- filiated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Submitted: 14 March 2025. Accepted: 9 April 2025. Early access: 21 May 2025. - 205 -