Clinical trial NCT03559816: Selective Use of Episiotomy: the Impact on Perineal Trauma.
Official title: Selective Use of Episiotomy: the Impact on Perineal Trauma. A Prospective Observational Study Based on a New Classification of Perineal Trauma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perineal Tear
Episiotomy Wound
Delivery; Injury, Maternal
Keywords: Episiotomy
Vaginal delivery
Perineal trauma
Laceration
Classification of second-degree laceration
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unassisted vaginal delivery of the study period.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Incidence of perineal trauma
timeFrame: At delivery
measure: Incidence of different degree of perineal trauma
timeFrame: At delivery
measure: Incidence of different subgroup of second-degree perineal trauma
timeFrame: At delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Study officials:
affiliation: Univerisity of Verona
name: Simone Garzon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisity of Verona
name: Massimo Franchi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisity of Verona
name: Francesca Parissone, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisity of Verona
name: Cecilia Lazzari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Giovanni Zanconato, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Ricciarda Raffaelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: