Skip to main content
Clinical Trials/NCT03559816
NCT03559816
Completed
Not Applicable

Selective Use of Episiotomy: the Impact on Perineal Trauma. A Prospective Observational Study Based on a New Classification of Perineal Trauma.

Universita di Verona1 site in 1 country10,000 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perineal Tear
Sponsor
Universita di Verona
Enrollment
10000
Locations
1
Primary Endpoint
Overall Incidence of perineal trauma
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG). Episiotomy is an intentional perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during the second stage of childbirth and has become the most common surgical procedure worldwide. A routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it failed to to demonstrate a clear protective role with no benefits both for mother and baby. Therefore the guidelines changed in a selective use of episiotomy, and we have introduced it in our routine obstetrics care. Nevertheless, second-degree lacerations comprise a wide range of lesions, from a minimal involvement to a massive damage of the perineal muscles. Therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma in the range of second degree lesions.

We designed a prospective observational study with the introduction of a new classification of perineal trauma recorded with the usual data retrieved in delivery ward register. The aim is to definitively investigate if selective use of episiotomy reduce the overall perineal trauma.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Universita di Verona
Responsible Party
Principal Investigator
Principal Investigator

Simone Garzon

Principal Investigator

Universita di Verona

Eligibility Criteria

Inclusion Criteria

  • Vaginal delivery

Exclusion Criteria

  • All situations in which episiotomy was recommended according to our Labour Ward's procedures (such as shoulder dystocia, breech presentation and operative delivery with vacuum) have been excluded.

Outcomes

Primary Outcomes

Overall Incidence of perineal trauma

Time Frame: At delivery

Overall Incidence of perineal trauma

Incidence of different degree of perineal trauma

Time Frame: At delivery

Incidence of different degree of perineal trauma

Incidence of different subgroup of second-degree perineal trauma

Time Frame: At delivery

Incidence of different subgroup of second-degree perineal trauma based on new classification

Study Sites (1)

Loading locations...

Similar Trials