Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Prospective Observational Study Comparing Two Classifications of Second-degree Perineal Tears in Spontaneous Vaginal Births, to Evaluate Their Correlation With Postpartum Clinical Outcomes.
University of Campania Luigi Vanvitelli
482 participants
Nov 4, 2025
OBSERVATIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria5
- 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 Criteria2
- Obstetric or medical conditions preventing spontaneous vaginal delivery
- Inability to understand study procedures or complete follow-up assessments
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07124676