Universita degli studi della Campania "Luigi Vanvitelli" - dipartimento della donna, bambino e chirurgia generale e specialistica,
Naples, Italy, 80138
Location status: Recruiting
Recruiting
NCT Number: NCT07124676
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
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)
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
hemoglobin reduction
Time frame: within 48 hours postpartum
significant hemoglobin reduction (>2 g/dL from pre- to post-delivery)
-
moderate-to-severe perineal pain
Time frame: within 48 hours postpartum
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
-
pathological Female Sexual Function Index (FSFI) total score
Time frame: within 48 hours after the delivery
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
Secondary outcomes
-
occult perineal or vaginal muscle lesions
Time frame: within 7 days postpartum for ultrasound assessment; at 3 months postpartum for FSFI evaluation.
occult perineal or vaginal muscle lesions on postpartum perineal ultrasound;
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Campania Luigi Vanvitelli
Other
Registry information
Official study title
Prospective Observational Study Comparing Two Classifications of Second-degree Perineal Tears in Spontaneous Vaginal Births, to Evaluate Their Correlation With Postpartum Clinical Outcomes.
Acronym: LAC-VAG-2025
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2028
- First posted
- Aug 15, 2025
- Registry last updated
- Apr 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.