Effects of Episioguide – a 60° Mediolateral Episiotomy Guide Device – on Post Suture Episiotomy Angle: A randomized controlled trial

Objectives: To compare the post-suture episiotomy angle between groups on which the Episioguide – a 60° mediolateral episiotomy (MLE) guide device was used and not used in the performance of MLE. Materials and Methods: This prospective randomized controlled trial was conducted at the HRH Princess Maha Chakri Sirindhorn Medical Center, Nakhon Nayok, Thailand. Eligible women were randomized into two groups, the first group was women who had a MLE using the Episioguide and the second group was women who had a conventional MLE. The primary outcome was a comparison of the rates of post-suture episiotomy angle in the safe zone (30°-60°) between the groups. Results: One-hundred and twelve eligible pregnant women were recruited, of whom 88 underwent randomization, 44 each in the Episioguide and conventional MLE groups.The procedures using the Episioguide had a significantly higher rate of a post-suture episiotomy angle in the desired 30°-60° range (relative risk (RR) 1.526, 95% confidence interval (CI) 1.023-2.277, p = 0.032), and there was a statistically significant difference in mean post suture angle between the two groups, 34.636° ± 9.445° in the Episioguide group and 27.614° ± 9.267° in the standard procedure group (mean difference 7.022, 95%CI 3.057-10.988, p = 0.001). Conclusion: Using the Episioguide to perform a MLE achieved a significantly higher rate of post-suture episiotomy angle in the safe zone compared with conventional MLE.