Selective Use of Episiotomy: the Impact on Perineal Trauma. (SEPT-1)
Selective Use of Episiotomy: the Impact on Perineal Trauma. A Prospective Observational Study Based on a New Classification of 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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Verona, Italy, 37125
- AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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).
Standardized selective use of Episiotomy as recommended by guidelines.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Incidence of perineal trauma
Time Frame: At delivery
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Overall Incidence of perineal trauma
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At delivery
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Incidence of different degree of perineal trauma
Time Frame: At delivery
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Incidence of different degree of perineal trauma
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At delivery
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Incidence of different subgroup of second-degree perineal trauma
Time Frame: At delivery
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Incidence of different subgroup of second-degree perineal trauma based on new classification
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At delivery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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: Giovanni Zanconato, M.D., Universita di Verona
- Principal Investigator: Ricciarda Raffaelli, M.D., Universita di Verona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEPT-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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