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Selective Use of Episiotomy: the Impact on Perineal Trauma.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03559816
Acronym
SEPT-1
Enrollment
10000
Registered
2018-06-18
Start date
2021-02-01
Completion date
2022-04-30
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery; Injury, Maternal, Episiotomy Wound, Perineal Tear

Keywords

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

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.

Interventions

OTHERClassification 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).

PROCEDURESelective use of Episiotomy

Standardized selective use of Episiotomy as recommended by guidelines.

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Incidence of perineal traumaAt deliveryOverall Incidence of perineal trauma
Incidence of different degree of perineal traumaAt deliveryIncidence of different degree of perineal trauma
Incidence of different subgroup of second-degree perineal traumaAt deliveryIncidence of different subgroup of second-degree perineal trauma based on new classification

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026