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RECRUITING
NCT07124676

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

Sponsor: University of Campania Luigi Vanvitelli

View on ClinicalTrials.gov

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)

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

482

Start Date

2025-11-04

Completion Date

2028-10-01

Last Updated

2026-04-28

Healthy Volunteers

No

Locations (1)

Universita degli studi della Campania "Luigi Vanvitelli" - dipartimento della donna, bambino e chirurgia generale e specialistica,

Naples, Italy, Italy