A Randomized, Open-labelled, Interventional Study to Evaluate the Incidence of Infection with or Without Use of Prophylactic Antibiotics in Patients of Episiotomy in a Normal Vaginal Delivery.

Aim: The aim of this study was to compare the incidence of infection in patients of episiotomy with or without the use of prophylactic antibiotics and to compare other morbidities associated with episiotomy and the role of antibiotics in their prevention and treatment.

Design: This open-labelled, randomized, interventional study was conducted in the Department of Obstetrics and Gynaecology at BYL Nair Charitable Hospital, Mumbai, Maharashtra, from October 2014 to October 2015. Three hundred women subjected to episiotomy during normal vaginal delivery in the labour ward from BYL Nair Charitable Hospital fulfilling specific criteria were enrolled in this study and randomly divided into two study groups A and B. In group A, 5-day course of prophylactic antibiotics including tablet cefixime 200 mg BD and tablet metronidazole 400 mg TDS was given, and in group B, prophylactic antibiotics were not given. The two groups were followed up for a period of 5-days postpartum and observed for signs and symptoms of infection.

Main Outcome: Presence of infection, i.e. presence of any positive finding including redness/pain/swelling/wound discharge or wound gape in group A (with antibiotics), was 0.7%, and in group B (without antibiotics) was 2%. The p value by Fischer's exact test was 0.622 which is not significant. Hence, there was no increased incidence of infection in either group, whether antibiotics were given or not.

Conclusion: To summarise, in our study, it was seen that prophylactic antibiotics did not decrease the incidence of infection in episiotomy following normal vaginal delivery in uncomplicated cases, but further studies are required to evaluate this topic and come to a more definitive conclusion.