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