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.

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.

The PAIN (Pelvic Area Injection for Numbness) Study

Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. The objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.