Clinical Trial

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

Study acronym: LAC-VAG-2025
Recruiting
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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)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-09.
Status change: Not Yet Recruiting → Recruiting 2026-04-22
Trial Details
NCT Number NCT07124676
Lead Sponsor University of Campania Luigi Vanvitelli
Conditions Vaginal Laceration During Delivery
Enrollment 482 participants
Start Date 2025-11-04
Primary Completion 2026-11-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-28