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

Overview

The goal of this observational study is to learn whether different classification systems for second-degree perineal tears can predict postpartum complications in women undergoing spontaneous vaginal childbirth. The main questions it aims to answer are: Does the Scandinavian classification better predict postpartum complications such as hemoglobin drop, perineal pain, occult muscle injury, and sexual dysfunction? Does the De Simone classification better correlate with these same postpartum outcomes? Researchers will compare the Scandinavian classification and the De Simone classification to see which system more accurately predicts clinically relevant postpartum complications. Participants will: Undergo standard clinical assessment after spontaneous vaginal delivery with a second-degree perineal tear Have their perineal tear classified using both the Scandinavian and De Simone systems Receive routine postpartum evaluation, including hemoglobin measurement, pain assessment (VAS), and perineal ultrasound Complete follow-up assessment of sexual function using the Female Sexual Function Index (FSFI)

Second-degree perineal tears are heterogeneous injuries involving the perineal muscles without anal sphincter involvement, and their anatomical variability may influence postpartum outcomes. Current standard classifications do not provide detailed subclassification, limiting risk stratification. This prospective, single-center observational study evaluates the prognostic performance of two detailed classification systems: the Scandinavian classification (based on the extent of the perineal body) and the De Simone classification (based on vaginal extension and muscle involvement). Participants are consecutively enrolled following spontaneous vaginal delivery with second-degree tears. Classification is performed during routine postpartum examination by trained clinicians using both systems, with independent assessment to minimize misclassification. Data are collected prospectively and managed in a secure electronic database with predefined validation and consistency checks. Source data verification is performed against clinical records, and variables are standardized through a predefined data dictionary. The statistical approach includes multivariable modeling to assess the association between tear subtypes and clinical outcomes, adjusting for relevant confounders. Model performance will be evaluated using standard calibration and discrimination metrics, with predefined strategies for handling missing data. The study is non-interventional and conducted in accordance with Good Clinical Practice.