NCT03559816

Selective Use of Episiotomy: the Impact on Perineal Trauma.

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (actual)
• Sponsor: Universita di Verona · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perineal Tear
• Episiotomy Wound
• Delivery; Injury, Maternal

Interventions

Type	Name	Description
OTHER	Classification of perineal tears based on new classification	Classifications according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG) and sub classification of second-degree lacerations based on the assumption that episiotomy involves the same anatomic structures of a second-degree laceration (perineal muscle, mucosa and skin), and divides them in two sub-groups, named A (if spontaneous vaginal tear is smaller than episiotomy) and B (if spontaneous vaginal tear is bigger than episiotomy).
PROCEDURE	Selective use of Episiotomy	Standardized selective use of Episiotomy as recommended by guidelines.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-12-31
• Completion: 2022-04-30
• First posted: 2018-06-18
• Last updated: 2022-05-12

Locations

1 site across 1 country: Italy