Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Condition(s) studied
Study 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
Primary outcome measure(s)
- hemoglobin reduction — within 48 hours postpartum
significant hemoglobin reduction (\>2 g/dL from pre- to post-delivery) - moderate-to-severe perineal pain — 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 — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Universita degli studi della Campania "Luigi Vanvitelli" - dipartimento della donna, bambino e chirurgia generale e specialistica, | Naples | Italy | Recruiting |
More University of Campania Luigi Vanvitelli trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07124676 on ClinicalTrials.gov ↗ ← All trials in Italy