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

NCT07124676 | Recruiting

• 1 other identifier: 0016346/i
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vaginal laceration; delivery

Outcome Measures

Primary Outcomes (3)

• hemoglobin reduction

  significant hemoglobin reduction (\>2 g/dL from pre- to post-delivery)

  within 48 hours postpartum

• moderate-to-severe perineal pain

  Visual Analog Scale (VAS) ≥ 5; (VAS; range 0-10, where 0 = no pain and 10 = worst imaginable pain); moderate-to-severe pain defined as VAS ≥ 5

  within 48 hours postpartum

• pathological Female Sexual Function Index (FSFI) total score

  FSFI total score modification after vaginal laceration Female Sexual Function Index (FSFI total score; range 2-36, where lower scores indicate worse sexual function and higher scores indicate better function), evaluated as change from baseline

  within 48 hours after the delivery

Secondary Outcomes (1)

• occult perineal or vaginal muscle lesions

  within 7 days postpartum for ultrasound assessment; at 3 months postpartum for FSFI evaluation.

Study Arms (1)

Women with spontaneous second-degree perineal tears

Participants are women who have a spontaneous vaginal birth and sustain a spontaneous second-degree perineal tear. Each tear is classified according to both the Scandinavian (Macedo et al., 2022) and De Simone systems during routine postpartum examination. No experimental intervention is performed; outcomes are collected through clinical records, postpartum examination, ultrasound, and validated questionnaires (FSFI).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals identifying as female at birth are eligible to participate, as the study population consists of women experiencing spontaneous vaginal delivery with spontaneous second-degree perineal tears.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women giving birth, who experience a spontaneous vaginal delivery resulting in a spontaneous second-degree perineal tear. Participants are recruited consecutively from the hospital's maternity ward during the study period.

You may qualify if:

• 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

You may not qualify if:

• Obstetric or medical conditions preventing spontaneous vaginal delivery
• Inability to understand study procedures or complete follow-up assessments

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

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

Naples, Italy, 80138, Italy

RECRUITING

Related Publications (1)

• Macedo MD, Ellstrom Engh M, Siafarikas F. Detailed classification of second-degree perineal tears in the delivery ward: an inter-rater agreement study. Acta Obstet Gynecol Scand. 2022 Aug;101(8):880-888. doi: 10.1111/aogs.14369. Epub 2022 May 11.

  PMID: 35546433 RESULT

Central Study Contacts

Marco La Verde, MD, researcher

CONTACT

+393389412266; marco.laverde@unicampania.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)