Perineal TearSEPT-1NCT03559816
Selective Use of Episiotomy: the Impact on Perineal Trauma.
An observational study of Perineal Tear and Episiotomy Wound, run by Universita di Verona at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Perineal Tear, Episiotomy Wound, Delivery; Injury, Maternal
- What is being tested?
- Classification of perineal tears based on new classification and Selective use of Episiotomy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Unassisted vaginal delivery of the study period.
Who may be able to join
- Vaginal delivery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125
About this study
Official title: 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.
- Conditions
- Perineal Tear, Episiotomy Wound, Delivery; Injury, Maternal
- Being tested
- Classification of perineal tears based on new classification, Selective use of Episiotomy
- Keywords
- Episiotomy, Vaginal delivery, Perineal trauma, Laceration, Classification of second-degree laceration
- Medical subject headings
- Wounds and Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classification of perineal tears based on new classificationOther
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).
Selective use of EpisiotomyProcedure or surgery
Standardized selective use of Episiotomy as recommended by guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Classification of perineal tears based on new classification; Procedure: Selective use of Episiotomy | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Incidence of perineal trauma
Overall Incidence of perineal trauma
Measured: At delivery
Incidence of different degree of perineal trauma
Incidence of different degree of perineal trauma
Measured: At delivery
Incidence of different subgroup of second-degree perineal trauma
Incidence of different subgroup of second-degree perineal trauma based on new classification
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Feb 2021
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Garzon, Universita di Verona
- Investigators
- Simone Garzon, M.D., Principal investigator, Univerisity of VeronaMassimo Franchi, M.D., Principal investigator, Univerisity of VeronaFrancesca Parissone, M.D., Principal investigator, Univerisity of VeronaCecilia Lazzari, M.D., Principal investigator, Univerisity of VeronaAntonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'InsubriaGiovanni Zanconato, M.D., Principal investigator, Universita di VeronaRicciarda Raffaelli, M.D., Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559816
- Sponsor's protocol ID
- SEPT-1
- Acronym
- SEPT-1
- Status last verified
- May 2022
- First submitted
- 6 Jun 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Use of Episiotomy: the Impact on Perineal Trauma. A Prospective Observational Study Based on a New Classification of Perineal Trauma.
- ClinicalTrials.gov ID
- NCT03559816
- Acronym / sponsor ID
- SEPT-1 / SEPT-1
- Conditions
- Perineal Tear, Episiotomy Wound, Delivery; Injury, Maternal
- Keywords
- Episiotomy, Vaginal delivery, Perineal trauma, Laceration, Classification of second-degree laceration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective use of Episiotomy | – | Other: Classification of perineal tears based on new classification, Procedure: Selective use of EpisiotomyVaginal 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unassisted vaginal delivery of the study period.
Key inclusion criteria (1 listed)
- Vaginal delivery
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classification of perineal tears based on new classificationClassifications 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). | Other | Selective use of Episiotomy |
| Selective use of EpisiotomyStandardized selective use of Episiotomy as recommended by guidelines. | Procedure or surgery | Selective use of Episiotomy |
Primary outcome
Overall Incidence of perineal trauma
Time frame: At delivery
Overall Incidence of perineal trauma
Incidence of different degree of perineal trauma
Time frame: At delivery
Incidence of different degree of perineal trauma
Incidence of different subgroup of second-degree perineal trauma
Time frame: At delivery
Incidence of different subgroup of second-degree perineal trauma based on new classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Garzon, M.D. principal investigator
Univerisity of Verona
Massimo Franchi, M.D. principal investigator
Univerisity of Verona
Francesca Parissone, M.D. principal investigator
Univerisity of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineal Tear and Episiotomy Wound, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Incidence of perineal trauma (time frame: At delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.