Comparing two ways to describe second-degree vaginal tears after spontaneous vaginal birth
Official title: Prospective Observational Study Comparing Two Classifications of Second-degree Perineal Tears in Spontaneous Vaginal Births, to Evaluate Their Correlation With Postpartum Clinical Outcomes.
Run by University of Campania Luigi Vanvitelli · NCT07124676 · Data updated 2026-11-12
This study will test whether two classification systems for second-degree perineal tears in women after spontaneous vaginal birth can better predict postpartum problems like blood loss, perineal pain, hidden muscle injury, and sexual dysfunction.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 482 (estimated) |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples, Italy) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | October 1, 2028 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07124676 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who have had a spontaneous vaginal delivery with a confirmed second-degree perineal tear and can provide informed consent.
✕Probably not a fit
Women who had operative deliveries, higher-degree perineal tears, cesarean delivery, or who cannot attend follow-up are unlikely to benefit from the results of this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study enrolling women with spontaneously occurring second-degree perineal tears after vaginal delivery. Trained clinicians will classify each tear using both the Scandinavian and De Simone systems during routine postpartum examination with independent assessments to reduce misclassification. Participants will receive routine postpartum follow-up including hemoglobin measurement, pain scoring (VAS), and evaluation for occult muscle injury and sexual dysfunction, with data entered into a secure electronic database. Multivariable statistical models will compare how well each classification predicts clinically relevant outcomes, using standard calibration and discrimination metrics and predefined methods for missing data.
Why it matters
Potential benefit: If one classification predicts complications more accurately, clinicians could better identify women at higher risk and tailor follow-up or interventions accordingly.
How similar studies have gone: While detailed subclassifications of perineal tears have been proposed previously, prospective head-to-head comparisons of the Scandinavian and De Simone systems for predicting postpartum outcomes are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Universita degli studi della Campania "Luigi Vanvitelli" - dipartimento della donna, bambino e chirurgia generale e specialistica,
Naples, Italy, Italy Recruiting
Study contacts
- Study coordinator: Marco La Verde, MD, researcher
- Email: marco.laverde@unicampania.it
- Phone: +393389412266
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.