Monsel´s solution for first degree perineal bleeding tears treatment: a randomized controlled clinical trial

Abstract

Introduction: During vaginal delivery, tears can occur in different areas of the lower genital tract. The policy of "restrictive episiotomy" increases anterior perineal trauma, mainly paraurethral tears. The topical application of Monsel´s solution in first degree perineal bleeding tears may benefit patients because of less use of anesthetics, sutures and procedure time. Objective: To determine if the Monsel´s solution stops active bleeding in first degree tears compared to traditional suture. Materials and methods: Randomized clinical trial, carried out at Hospital Nacional "Prof. Alejandro Posadas" from January 2011 to December 2013. 330 patients with recent postpartum vaginal delivery were admitted with a diagnosis of first degree bleeding tears. They were randomized to receive the application of Monsel´s solution, until stopping bleeding (intervention group) or traditional suture (control group). The primary outcome was the stoppage of active bleeding. Secondary outcomes were: patient discomfort with the procedure, practicality of the procedure, alterations in the scarring of the tear and wound infections. Crude and adjusted ORs and 95% CI were calculated. Analysis was done by intention to treat. The study was approved by the Bioethics Committee of the Hospital. Results: Monsel´s solution was effective for the stoppage of active bleeding in 86.7% of first degree bleeding tears. Out of 150 patients randomized to the intervention group, 130 met the primary outcome, ORc 0.04 (95% CI 0.01-0.27)/ORa 0.05 (95% CI 0.01-0.34) Monsel´s solution was safe, because it did not interfere with the scarring process It also offered a protective aspect on wound infections. The procedure was practical and simple for the intervening professionals and, despite being an irritant for the mucous; it was well tolerated by the patients. Conclusion: The Monsel´s solution appears effective, practical and safe for treatment of first degree bleeding tears.