Selective Use of Episiotomy: the Impact on Perineal Trauma. (SEPT-1)

University of Verona

Status: Completed

Conditions: Episiotomy Wound; Delivery; Injury, Maternal; Perineal Tear

Treatments: Procedure: Selective use of Episiotomy; Other: Classification of perineal tears based on new classification

Study type: Observational

Funder types: Other

Identifiers

NCT03559816

SEPT-1

Details and patient eligibility

About

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.

Enrollment: 10,000 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10,000 participants in 2 patient groups

Selective use of Episiotomy

Description:

Vaginal delivery assisted with selective use of episiotomy and prospective classification of perineal laceration with a sub-classification of second-degree tears. Data of subclassifications are registered with data usually recorded in delivery ward register.

Treatment:

Procedure: Selective use of Episiotomy

Other: Classification of perineal tears based on new classification

Not selective use of Episiotomy

Description:

Vaginal delivery assisted without a selective use of episiotomy. Data retrospectively retrieved by delivery ward register that were usually recorded.