NCT07124676 Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
| NCT ID | NCT07124676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Campania Luigi Vanvitelli |
| Condition | Vaginal Laceration During Delivery |
| Study Type | OBSERVATIONAL |
| Enrollment | 482 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 482 participants in total. It began in 2025-11-04 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07124676 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vaginal Laceration During Delivery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07124676 currently recruiting?
Yes, NCT07124676 is actively recruiting participants. Contact the research team at marco.laverde@unicampania.it for enrollment information.
Where is the NCT07124676 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07124676 clinical trial?
NCT07124676 is sponsored by University of Campania Luigi Vanvitelli. The trial plans to enroll 482 participants.