Selective Use of Episiotomy: the Impact on Perineal Trauma.

Study Overview
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Brief Summary
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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.

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

Conditions
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Perineal Tear, Episiotomy Wound, Delivery; Injury, Maternal

Intervention / Treatment
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* Other: Classification of perineal tears based on new classification
* Procedure: Selective use of Episiotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Selective use of Episiotomy<br>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<br>* 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).<br>Procedure: Selective use of Episiotomy<br>* Standardized selective use of Episiotomy as recommended by guidelines.<br>|
| Not selective use of Episiotomy<br>Vaginal delivery assisted without a selective use of episiotomy. Data retrospectively retrieved by delivery ward register that were usually recorded. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episiotomy, Vaginal delivery, Perineal trauma, Laceration, Classification of second-degree laceration