Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications. (LAC-VAG-2025)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Vaginal Laceration During Delivery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 482

Contacts and Locations

• Study Contact: Name: Marco La Verde, MD, researcher; Phone Number: +393389412266; Email: marco.laverde@unicampania.it

Study Locations

• Italy
  • Italy
    • Naples, Italy, Italy, 80138
      • Recruiting
      • Universita degli studi della Campania "Luigi Vanvitelli" - dipartimento della donna, bambino e chirurgia generale e specialistica,
      • Contact: Marco La Verde, MD, researcher; Phone Number: +393389412266; Email: marco.laverde@unicampania.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women giving birth, who experience a spontaneous vaginal delivery resulting in a spontaneous second-degree perineal tear. Participants are recruited consecutively from the hospital's maternity ward during the study period.

Description

Inclusion Criteria:

• Female at birth
• Age ≥ 18 years
• Spontaneous vaginal delivery
• Presence of a spontaneous second-degree perineal tear confirmed on -postpartum examination
• Ability and willingness to provide informed consent

Exclusion Criteria:

• Obstetric or medical conditions preventing spontaneous vaginal delivery
• Inability to understand study procedures or complete follow-up assessments

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Women with spontaneous second-degree perineal tears; Participants are women who have a spontaneous vaginal birth and sustain a spontaneous second-degree perineal tear. Each tear is classified according to both the Scandinavian (Macedo et al., 2022) and De Simone systems during routine postpartum examination. No experimental intervention is performed; outcomes are collected through clinical records, postpartum examination, ultrasound, and validated questionnaires (FSFI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin reduction	significant hemoglobin reduction (>2 g/dL from pre- to post-delivery)	within 48 hours postpartum
moderate-to-severe perineal pain	Visual Analog Scale (VAS) ≥ 5; (VAS; range 0-10, where 0 = no pain and 10 = worst imaginable pain); moderate-to-severe pain defined as VAS ≥ 5	within 48 hours postpartum
pathological Female Sexual Function Index (FSFI) total score	FSFI total score modification after vaginal laceration Female Sexual Function Index (FSFI total score; range 2-36, where lower scores indicate worse sexual function and higher scores indicate better function), evaluated as change from baseline	within 48 hours after the delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occult perineal or vaginal muscle lesions	occult perineal or vaginal muscle lesions on postpartum perineal ultrasound;	within 7 days postpartum for ultrasound assessment; at 3 months postpartum for FSFI evaluation.

Collaborators and Investigators

• Sponsor: University of Campania Luigi Vanvitelli

Publications and helpful links

General Publications

• Macedo MD, Ellstrom Engh M, Siafarikas F. Detailed classification of second-degree perineal tears in the delivery ward: an inter-rater agreement study. Acta Obstet Gynecol Scand. 2022 Aug;101(8):880-888. doi: 10.1111/aogs.14369. Epub 2022 May 11.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 9, 2025
• First Submitted That Met QC Criteria: August 9, 2025
• First Posted (Actual): August 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: delivery; vaginal laceration
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 0016346/i

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding the protection of participants' privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No