Selective Use of Episiotomy: the Impact on Perineal Trauma.
SEPT-1
SEPT-1
Sponsor study identifier
observational
10,000
1 country
1
Study Start
February 1, 2021
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
April 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2018
Actual (reported)June 18, 2018
Actual (reported)February 1, 2021
Actual (reported)December 31, 2021
Actual (reported)April 30, 2022
Actual (reported)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
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.
Vaginal delivery assisted without a selective use of episiotomy. Data retrospectively retrieved by delivery ward register that were usually recorded.
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).
Unassisted vaginal delivery of the study period.
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125, Italy
Simone Garzon, M.D.
Univerisity of Verona
Massimo Franchi, M.D.
Univerisity of Verona
Francesca Parissone, M.D.
Univerisity of Verona
Cecilia Lazzari, M.D.
Univerisity of Verona
10,000 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2018
First Posted
June 18, 2018
Study Start
February 1, 2021
Actual (reported)Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
Standardized selective use of Episiotomy as recommended by guidelines.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Antonio Simone Laganà, M.D.
Università degli Studi dell'Insubria
Giovanni Zanconato, M.D.
Universita di Verona
Ricciarda Raffaelli, M.D.
Universita di Verona
Primary Completion
December 31, 2021
Actual (reported)Study Completion
April 30, 2022
Actual (reported)Last Updated
May 12, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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