Actively Recruiting
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Led by University of Campania Luigi Vanvitelli · Updated on 2026-04-28
482
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female at birth
- Age 63; 18 years
- Spontaneous vaginal delivery
- Presence of a spontaneous second-degree perineal tear confirmed on postpartum examination
- Ability and willingness to provide informed consent
You will not qualify if you...
- Obstetric or medical conditions preventing spontaneous vaginal delivery
- Inability to understand study procedures or complete follow-up assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universita degli studi della Campania "Luigi Vanvitelli" - dipartimento della donna, bambino e chirurgia generale e specialistica,
Naples, Italy, Italy, 80138
Actively Recruiting
Research Team
M
Marco La Verde, MD, researcher
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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