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

NCT07124676 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 482

Last updated 2026-04-28

No results posted yet for this 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)

Conditions

  • Vaginal Laceration During Delivery

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2026-11-01
Completion
2028-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124676 on ClinicalTrials.gov