Actively Recruiting

Age: 18Years +
FEMALE
NCT07124676

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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