Selective Use of Episiotomy: the Impact on Perineal Trauma.

Completed

• Conditions: Perineal Tear; Episiotomy Wound; Delivery; Injury, Maternal
• Interventions: Other: Classification of perineal tears based on new classification; Procedure: Selective use of Episiotomy

• Registration Number: NCT03559816
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Study Start: 2021-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Selective use of Episiotomy	Selective use of Episiotomy	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.
Selective use of Episiotomy	Classification of perineal tears based on new classification	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.

Primary Outcome Measures

Name	Time	Method
Overall Incidence of perineal trauma	At delivery	Overall Incidence of perineal trauma
Incidence of different degree of perineal trauma	At delivery	Incidence of different degree of perineal trauma
Incidence of different subgroup of second-degree perineal trauma	At delivery	Incidence of different subgroup of second-degree perineal trauma based on new classification

Trial Locations

Locations (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology; 🇮🇹 Verona, Italy