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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.

Study acronym: LAC-VAG-2025
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Oct 1, 2026 to Nov 1, 2026
    • Start date changed from estimate of Oct 1, 2025 to Nov 4, 2025
    • Eligibility criteria shortened, about 15 words
    • Study description shortened, about 459 words
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT07124676
Lead Sponsor University of Campania Luigi Vanvitelli
Conditions
(from sponsor)
Vaginal Laceration During Delivery
Enrollment 482 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov