Selective Use of Episiotomy: the Impact on Perineal Trauma.

NCT03559816 | Completed DMC

• 1 other identifier: SEPT-1
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Keywords

Episiotomy; Vaginal delivery; Perineal trauma; Laceration; Classification of second-degree laceration

Outcome Measures

Primary Outcomes (3)

• Overall Incidence of perineal trauma

  Overall Incidence of perineal trauma

  At delivery

• Incidence of different degree of perineal trauma

  Incidence of different degree of perineal trauma

  At delivery

• Incidence of different subgroup of second-degree perineal trauma

  Incidence of different subgroup of second-degree perineal trauma based on new classification

  At delivery

Study Arms (2)

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.

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

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.

Interventions

Classification of perineal tears based on new classification 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

Selective use of Episiotomy PROCEDURE

Standardized selective use of Episiotomy as recommended by guidelines.

Selective use of Episiotomy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Unassisted vaginal delivery of the study period.

You may qualify if:

• Vaginal delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

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

Verona, 37125, Italy

Location

MeSH Terms

Conditions

Wounds and Injuries; Lacerations

Study Officials

• Simone Garzon, M.D.

  Univerisity of Verona

  PRINCIPAL INVESTIGATOR

• Massimo Franchi, M.D.

  Univerisity of Verona

  PRINCIPAL INVESTIGATOR

• Francesca Parissone, M.D.

  Univerisity of Verona

  PRINCIPAL INVESTIGATOR

• Cecilia Lazzari, M.D.

  Univerisity of Verona

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Giovanni Zanconato, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Ricciarda Raffaelli, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

IT (1)