A randomised controlled trial to study the outcome of ‘Routine episiotomy’ versus ‘No episiotomy’ on perineal injury and pelvic floor dysfunction during normal vaginal delivery among primigravida women: A Pilot study

Pregnancy and childbirth predispose women to perineal trauma and pelvic floor dysfunction, resulting in increased rates of urinary and anal incontinence, perineal pain and sexual dysfunction. Episiotomy is a surgical procedure that is widely used in our labour rooms to facilitate delivery and prevent such complications of labor like perineal and anorectal trauma. However, routine episiotomy is now considered a form of obstetric violence. However, in one French study episiotomy was performed in 68% of first-time mothers and 31% of multiparas. [1] However, as early as the 1980s, the value of preventive episiotomy was called into question by publications highlighting the increased risk of rectal and anal sphincter lesions after episiotomy. [2] Recently some studies have suggested that episiotomy should never be performed, however not adequately proven in randomized controlled trials. [3] FIGO also endorses the restrictive use of episiotomy, rather than its routine use. The need to reduce episiotomy rates stems from evidence that episiotomies cause serious perineal lacerations, rather than prevent them.[4] Routine mediolateral episiotomy (RMLE) decreases the risk of anterior perineal lacerations, but increases the risk of posterior perineal lacerations, and the need for suturing[5,6]. Even in the context of shoulder dystocia, episiotomy has not shown to have any clear benefits.[7] There is some evidence that women with a prior episiotomy have a two-fold increased risk of 2nd degree lacerations in subsequent vaginal deliveries. In addition episiotomy may be associated with a decrease in pelvic floor musculature strength, more perineal pain, and future dyspareunia, when compared with spontaneous laceration. The effect of mediolateral episiotomy on obstetric anal sphincter injuries (OASIS) in spontaneous vaginal deliveries is also not completely clear. Although a recent metaanalysis of observational data concluded that mediolateral episiotomy may reduce the incidence of OASIS and should not be withheld especially in nulliparous women. In fact after adjusting for confounding factors, mediolateral episiotomy has shown a significant 2.5 times reduction in developing lacerations in primiparous women compared with no episiotomy[6]. However, other studies have shown that episiotomy increases the risk of anal incontinence after vaginal birth by 1.7.[8] A recent study suggested that mediolateral episiotomy is not protective of occurrence of OASIS, but sample size was small and therefore the study was not powered to provide substantial clinical conclusions. [9]

The primary aim of this study was to determine the effect of routine episiotomy versus no episiotomy on perineal lacerations and postpartum pelvic floor outcomes including urinary and anal incontinence and perineal pain in nulliparous women. We also aim to assess the effect of obstetrics related perineal injury on novel biomarkers in nulliparous women. Recent efforts in biomarker research have identified some organ-selective markers that have sufficient sensitivity to detect organ damage. Some organ specific biomarkers are glial fibrillary acidic protein for brain injury, kidney injury marker-1 for kidney injury, cardiac troponin for heart damage, intestinal- type fatty acid binding protein for gut injury, and d-dimer for coagulopathy. They have shown clinical diagnostic utility to detect injury to individual organs. But the role of biomarkers in genital injury has not been explored yet. As a pilot study, we plan to recruit 100 women as per the inclusion and exclusion criteria, 50 each in routine episiotomy and no episiotomy group and determine the effect of routine episiotomy vrs no episiotomy on perineal lacerations and postpartum pelvic floor outcomes including urinary and anal incontinence, sexual function and perineal pain in nulliparous women. Also we will assess the effect of obstetrics related perineal injury on novel biomarkers in nulliparous women.