Clinical Research Directory

Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.

Sponsor: University of Campania Luigi Vanvitelli

Summary

Second-degree perineal tears are one of the most common complications during vaginal childbirth. These injuries involve the muscles of the perineum but do not affect the anal sphincter. Although frequent, they vary greatly in severity, and their short- and long-term consequences can include pain, bleeding, hidden muscle damage, and sexual function problems. Currently, there is no widely used, detailed system to sub-classify these tears, which makes it harder to study their relationship with postpartum complications and to guide follow-up care. Two classification systems have been proposed: The Scandinavian classification (Macedo et al., 2022), which grades second-degree tears based on the percentage of the perineal body involved (2A: \<50%, 2B: \>50%, 2C: entire perineal body and/or large vaginal extension). The De Simone classification, which describes tears according to their extension along the vaginal wall (lower third, middle third, upper third/fornices) and muscle involvement, with specific codes for isolated locations. This prospective, single-center observational study at AOU Vanvitelli will enroll 482 women who have a spontaneous vaginal delivery and a spontaneous second-degree perineal tear. Each tear will be independently classified according to both systems, without any additional procedures beyond routine clinical care. The primary aim is to determine which classification better correlates with important postpartum outcomes: significant drop in hemoglobin levels, moderate-to-severe perineal pain (VAS ≥5), occult lesions detected by postpartum perineal ultrasound, and abnormal Female Sexual Function Index (FSFI) scores at follow-up. By directly comparing these two systems in the same population, the study seeks to identify whether a more detailed classification can improve prediction of complications, guide patient counseling, and inform postpartum follow-up. The findings may contribute to better standardization in describing these tears and improved care for women after childbirth.

Official title: Prospective Observational Study Comparing Two Classifications of Second-degree Perineal Tears in Spontaneous Vaginal Births, to Evaluate Their Correlation With Postpartum Clinical Outcomes.

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