Episiotomy WoundNCT04696796
Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy
A study testing Mediolateral Episiotomy with BasIQ-4 Surgical Knife and Mediolateral Episiotomy with Episiotomy Scissors in people with Episiotomy Wound, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Mediolateral Episiotomy with BasIQ-4 Surgical Knife and Mediolateral Episiotomy with Episiotomy Scissors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Mar 2023
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous singleton pregnancies > 37th gestational week
- Estimated fetal weight between 3000-4000g
- The need for an episiotomy in the second stage of labor
- Vertex presentation
Who cannot join
- Additional internal disease
- Inability to communicate in Turkish and English
- Multiple pregnancy
- Episiotomies in emergency situations without crowning the baby's head
- Using vacuum device at birth
Trial locations and contacts
1 site in 1 country.
About this study
Episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. Postpartum perineal pain affects patients' lives significantly and causes negative effects on work life, social life and family relations. Median episiotomy is associated with 3-4 times increased anal sphincter injury as well as easy recovery. Therefore, mediolateral episiotomy is preferred in Europe. The common feature was that scissors are used in previous studies and the incision was made from the central to the distal. A randomized controlled clinical study is planned to compare the scissors and episiotomy device BasIQ-4, which carries scalpel, holding apparatus, and cuts from distal to the center in mediolateral episiotomy. This is the first study in humans in this field.
Read the detailed description
Pregnant women who applied to Ege University Gynecology and Obstetrics Department Delivery Room Service and had vaginal delivery will be included in the study after obtaining their consent. When the cases meeting the inclusion criteria will be taken to the delivery table for delivery, verbal consent will be obtained by the physician if the need for episiotomy is determined by the physician in the second stage of delivery. Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be opened with scissors or Basiq-4 according to computer generated randomization. The presence of shoulder dystocia during delivery, the number of moves for episiotomy incision, the duration of stage 2, fetal weight, the degree of perineal injury, any additional injury, and urethral injury will be recorded in the prepared case form. Then, the episiotomy incision will be continuously sutured with 2-0 slow dissolving polyglactin 910 suture material for all cases.
The length of episiotomy after suturing and the length of perineal injury, if any, will be measured with a sterile ruler and recorded on the case form. Postpartum discharge is carried out 48 hours after birth in accordance with the Ministry of Health Regulations. Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS).
The cases will be evaluated by the study team again, and notes regarding episiotomy length, infection, pain, incision separation, fecal incontinence, rectovaginal fistula, and painful defecation will be recorded on the case form six months after delivery. Participants will be requested to fill FSFI forms to evaluate their sexual lives.
- Conditions
- Episiotomy Wound
- Being tested
- Mediolateral Episiotomy with BasIQ-4 Surgical Knife, Mediolateral Episiotomy with Episiotomy Scissors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediolateral Episiotomy with BasIQ-4 Surgical KnifeProcedure or surgery
Mediolateral episiotomy will be performed with BasIQ-4 Surgical Knife which cuts from distal to the center with inner knife.
Mediolateral Episiotomy with Episiotomy ScissorsProcedure or surgery
Mediolateral episiotomy will be made from the central to the distal with episiotomy scissors
| Study group | Role | What they receive |
|---|---|---|
| BasIQ-4 Surgical Knife | Experimental | Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be preformed with BasIQ-4 Surgical Knife according to computer generated randomization. Receives: Procedure: Mediolateral Episiotomy with BasIQ-4 Surgical Knife |
| Episiotomy Scissors | Active comparator | Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be preformed with episiotomy scissors according to computer generated randomization. Receives: Procedure: Mediolateral Episiotomy with Episiotomy Scissors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessed by VAS at 48 Hours After Birth
Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS). The participants will asked to rate current pain on a 10-cm visual analog scale (VAS), with 0 being no pain and 10 the worst pain imaginable 48 hours after operation.
Measured: 48 hours
FSFI Score
Participants will be requested to fill FSFI (Female Sexual Function Index) forms to evaluate their sexual lives six months after birth. The FSFI consists of 19 questions and is a validated questionnaire for the assessment of sexual function. The questions are grouped into the domains of libido, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores reflect better sexual function (maximum score 36), including pain, in which 0 reflects lots of pain and 5 reflects the absence of pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Sep 2022
- Primary completion1 Oct 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696796
- Sponsor's protocol ID
- 19-9.1/45
- Status last verified
- Mar 2023
- First submitted
- 4 Jan 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy
- ClinicalTrials.gov ID
- NCT04696796
- Acronym / sponsor ID
- 19-9.1/45
- Conditions
- Episiotomy Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 6 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.
Episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. Postpartum perineal pain affects patients' lives significantly and causes negative effects on work life, social life and family relations. Median episiotomy is associated with 3-4 times increased anal sphincter injury as well as easy recovery. Therefore, mediolateral episiotomy is preferred in Europe. The common feature was that scissors are used in previous studies and the incision was made from the central to the distal. A randomized controlled clinical study is planned to compare the scissors and episiotomy device BasIQ-4, which carries scalpel, holding apparatus, and cuts from distal to the center in mediolateral episiotomy. This is the first study in humans in this field.
Detailed description
Pregnant women who applied to Ege University Gynecology and Obstetrics Department Delivery Room Service and had vaginal delivery will be included in the study after obtaining their consent. When the cases meeting the inclusion criteria will be taken to the delivery table for delivery, verbal consent will be obtained by the physician if the need for episiotomy is determined by the physician in the second stage of delivery. Following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be opened with scissors or Basiq-4 according to computer generated randomization. The presence of shoulder dystocia during delivery, the number of moves for episiotomy incision, the duration of stage 2, fetal weight, the degree of perineal injury, any additional injury, and urethral injury will be recorded in the prepared case form. Then, the episiotomy incision will be continuously sutured with 2-0 slow dissolving polyglactin 910 suture material for all cases.
The length of episiotomy after suturing and the length of perineal injury, if any, will be measured with a sterile ruler and recorded on the case form. Postpartum discharge is carried out 48 hours after birth in accordance with the Ministry of Health Regulations. Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS).
The cases will be evaluated by the study team again, and notes regarding episiotomy length, infection, pain, incision separation, fecal incontinence, rectovaginal fistula, and painful defecation will be recorded on the case form six months after delivery. Participants will be requested to fill FSFI forms to evaluate their sexual lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BasIQ-4 Surgical Knife | Experimental | Procedure: Mediolateral Episiotomy with BasIQ-4 Surgical KnifeFollowing the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be preformed with BasIQ-4 Surgical Knife according to computer generated randomization. |
| Episiotomy Scissors | Active comparator | Procedure: Mediolateral Episiotomy with Episiotomy ScissorsFollowing the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be preformed with episiotomy scissors according to computer generated randomization. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous singleton pregnancies > 37th gestational week
- Estimated fetal weight between 3000-4000g
- The need for an episiotomy in the second stage of labor
- Vertex presentation
Key exclusion criteria (5 listed)
- Additional internal disease
- Inability to communicate in Turkish and English
- Multiple pregnancy
- Episiotomies in emergency situations without crowning the baby's head
- Using vacuum device at birth
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 |
|---|---|---|
| Mediolateral Episiotomy with BasIQ-4 Surgical KnifeMediolateral episiotomy will be performed with BasIQ-4 Surgical Knife which cuts from distal to the center with inner knife. | Procedure or surgery | BasIQ-4 Surgical Knife |
| Mediolateral Episiotomy with Episiotomy ScissorsMediolateral episiotomy will be made from the central to the distal with episiotomy scissors | Procedure or surgery | Episiotomy Scissors |
Primary outcome
Pain Assessed by VAS at 48 Hours After Birth
Time frame: 48 hours
Participants will be reassessed during discharge in terms of pain with the Visual Pain Scale (VAS). The participants will asked to rate current pain on a 10-cm visual analog scale (VAS), with 0 being no pain and 10 the worst pain imaginable 48 hours after operation.
FSFI Score
Time frame: 6 months
Participants will be requested to fill FSFI (Female Sexual Function Index) forms to evaluate their sexual lives six months after birth. The FSFI consists of 19 questions and is a validated questionnaire for the assessment of sexual function. The questions are grouped into the domains of libido, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores reflect better sexual function (maximum score 36), including pain, in which 0 reflects lots of pain and 5 reflects the absence of pain.
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 2 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediolateral Episiotomy with BasIQ-4 Surgical Knife and Mediolateral Episiotomy with Episiotomy Scissors in people with Episiotomy Wound, run by Ege University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 2 Mar 2023. 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 Turkey (Türkiye). 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?
Pain Assessed by VAS at 48 Hours After Birth (time frame: 48 hours). The study lists 2 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 2 Mar 2023.