Selective Use of Episiotomy: the Impact on Perineal Trauma.

NCT ID: NCT03559816

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-04-30

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.

Conditions

Perineal Tear; Episiotomy Wound; Delivery; Injury, Maternal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Classification of perineal tears based on new classification

Intervention Type: OTHER

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).

Selective use of Episiotomy

Intervention Type: PROCEDURE

Standardized selective use of Episiotomy as recommended by guidelines.

Not selective use of Episiotomy

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

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Selective use of Episiotomy

Standardized selective use of Episiotomy as recommended by guidelines.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Simone Garzon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Garzon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Verona

Massimo Franchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Verona

Francesca Parissone, M.D.

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Verona

Cecilia Lazzari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Verona

Antonio Simone Laganà, M.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Giovanni Zanconato, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Ricciarda Raffaelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, , Italy

Countries

Italy

Other Identifiers

SEPT-1

Identifier Type: -

Identifier Source: org_study_id