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Completed

NCT Number: NCT03559816

Selective Use of Episiotomy: the Impact on Perineal Trauma.

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Verona, 37125, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Standardized selective use of Episiotomy as recommended by guidelines.

Primary outcomes

  1. Overall Incidence of perineal trauma

    Time frame: At delivery

    Overall Incidence of perineal trauma

  2. Incidence of different degree of perineal trauma

    Time frame: At delivery

    Incidence of different degree of perineal trauma

  3. Incidence of different subgroup of second-degree perineal trauma

    Time frame: At delivery

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

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

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

Acronym: SEPT-1

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 18, 2018
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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