Selective Use of Episiotomy: the Impact on Perineal Trauma.

Perineal Tear Clinical Trial

— SEPT-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559816
• Other study ID #: SEPT-1
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delivery; Injury, Maternal
• Episiotomy Wound
• Perineal Tear
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Incidence of perineal trauma	Overall Incidence of perineal trauma	At delivery
Primary	Incidence of different degree of perineal trauma	Incidence of different degree of perineal trauma	At delivery
Primary	Incidence of different subgroup of second-degree perineal trauma	Incidence of different subgroup of second-degree perineal trauma based on new classification	At delivery