Episiotomy; ComplicationsNCT04719533
Outcomes Following Pre-marking of Episiotomy Location
A study testing Pre-marking of episiotomy location in people with Episiotomy; Complications and Episiotomy Extended by Laceration, run by Sharon Davidesko MD at 1 site in Israel.
Trial summary
To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy; Complications, Episiotomy Extended by Laceration, Episiotomy Infection
- What is being tested?
- Pre-marking of episiotomy location
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 17 May 2021to 24 Sep 2025
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women 18 years of age or older who present in active labour to our center and consent to participate in the study
Who cannot join
- women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 84101
Sharon Davidesko, MD, +972546837362, shazadmoni85@gmail.com
About this study
Official title: Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Read the detailed description
Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.
Study type: prospective randomized-controlled trial
- Being tested
- Pre-marking of episiotomy location
- Keywords
- episiotomy, episiotomy complications, premarked episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-marking of episiotomy locationOther
A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
| Study group | Role | What they receive |
|---|---|---|
| Pre-marked episiotomy location | Experimental | Women in this group will undergo pre-marking of episiotomy location Receives: Other: Pre-marking of episiotomy location |
| No pre-marked episiotomy location | No intervention | Women in this group will not undergo pre-marking of episiotomy location |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended laceration of the episiotomy
Additional perineal tears originating from the original episiotomy, as described in the birth chart
Measured: Up to 1 hour following the episiotomy
Third- and fourth-degree perineal tears
Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
Measured: Up to 2 hours following the episiotomy
Post-partum hemorrhage
Early (<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
Measured: Up to 6 weeks following delivery
Blood transfusion requirement
Any requirement for blood products following delivery as documented in the hospital discharge
Measured: Up to 5 days following delivery
Episiotomy site infection
any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
Measured: Up to 6 weeks following delivery
Requirement of resuturing of episiotomy or evacuation of hematoma
Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
Measured: up to 6 weeks following delivery
Long-term symptoms related to episiotomy
Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
Measured: Up to 5 years following delivery
Perineal tears in subsequent deliveries
As recorded in hospital records
Measured: Up to 5 years following delivery
Surgical correction of episiotomy
Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
Measured: Up to 5 years following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start17 May 2021
- Primary completion24 Sep 2025 (estimated)
- Study completion24 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy; ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized-controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharon Davidesko MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sharon Davidesko MD, Soroka University Medical Center
- Investigators
- Sharon Davidesko, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719533
- Sponsor's protocol ID
- SOR-0089-20-CTIL
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2020
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data is to be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
- ClinicalTrials.gov ID
- NCT04719533
- Acronym / sponsor ID
- SOR-0089-20-CTIL
- Keywords
- episiotomy, episiotomy complications, premarked episiotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sharon Davidesko MDUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 24 Sep 2025 (estimated)
- Study completion
- 24 Sep 2025 (estimated)
- First posted
- 22 Jan 2021 (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.
To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Detailed description
Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.
Study type: prospective randomized-controlled trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pre-marked episiotomy location | Experimental | Other: Pre-marking of episiotomy locationWomen in this group will undergo pre-marking of episiotomy location |
| No pre-marked episiotomy location | No intervention | –Women in this group will not undergo pre-marking of episiotomy location |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women 18 years of age or older who present in active labour to our center and consent to participate in the study
Key exclusion criteria (1 listed)
- women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
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 |
|---|---|---|
| Pre-marking of episiotomy locationA template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group | Other | Pre-marked episiotomy location |
Primary outcome
Extended laceration of the episiotomy
Time frame: Up to 1 hour following the episiotomy
Additional perineal tears originating from the original episiotomy, as described in the birth chart
Third- and fourth-degree perineal tears
Time frame: Up to 2 hours following the episiotomy
Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
Post-partum hemorrhage
Time frame: Up to 6 weeks following delivery
Early (<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
Blood transfusion requirement
Time frame: Up to 5 days following delivery
Any requirement for blood products following delivery as documented in the hospital discharge
Episiotomy site infection
Time frame: Up to 6 weeks following delivery
any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
Requirement of resuturing of episiotomy or evacuation of hematoma
Time frame: up to 6 weeks following delivery
Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
Long-term symptoms related to episiotomy
Time frame: Up to 5 years following delivery
Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
Perineal tears in subsequent deliveries
Time frame: Up to 5 years following delivery
As recorded in hospital records
Surgical correction of episiotomy
Time frame: Up to 5 years following delivery
Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No. No data is to be shared with other researchers
Related trials for Episiotomy; Complications
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Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
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Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Recruiting
Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
Dyspareunia
Active, not recruiting
MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery
Perineal Scars, Delivery Complication
Active, not recruiting
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Pelvic Floor Disorders, Fecal Incontinence
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.
Sharon Davidesko, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-marking of episiotomy location in people with Episiotomy; Complications and Episiotomy Extended by Laceration, run by Sharon Davidesko MD at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Davidesko, MD (+972546837362, shazadmoni85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extended laceration of the episiotomy (time frame: Up to 1 hour following the episiotomy). The study lists 9 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 21 Oct 2021.