Episiotomy WoundNCT03486132
Repair of Lateral And Mediolateral Episiotomy
A study testing repair of episiotomy in people with Episiotomy Wound, run by Ain Shams University at 1 site in Egypt.
Trial summary
Episiotomy is an incision in the perineum carried out during the second stage of labour to facilitate the birth of an infant. It is an important surgical procedure with physiological, psychological and socio-economic effects on women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- repair of episiotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2017to May 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primipara women.
- Fullterm pregnancy.
- Lateral or mediolateral episiotomy done in selective rather than liberal episiotomy.
Who cannot join
- Risk factor of trauma eg; macrosomia, congenital fetal malformations as (exophthalmous major, hydrocephalus, spinal cord teratoma….etc.
- Instrumental delivery.
- Primipara refuses to be in the study.
- Other techniques of episiotomy.
- Preterm onset of labour.
- Indication for CS eg; CPD, malposition and malpresentation, fetal distress….etc.
- Use of epidural analgesics.
- Factors affecting wound healing eg;DM, corticosteroid therapy, chronic debilitating diseases…etc.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain SHams Maternity Hospital
Cairo, 002
Mohamed Samy, MD, 01001947488, mohammedsamy8132@gmail.com
About this study
Official title: Continuous Versus Interrupted Suturing In Repair of Lateral And Mediolateral Episiotomy
Episiotomy is an incision in the perineum carried out during the second stage of labour to facilitate the birth of an infant. It is an important surgical procedure with physiological, psychological and socio-economic effects on women. Therefore, not only the decision to carry out an episiotomy but also how it is performed and the quality of aftercare are important The two most often performed are the lateral and median episiotomy, as well as mediolateral episiotomy.
Two common methods of repair of episiotomy include continuous and interrupted methods This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.
Read the detailed description
Aim of the work:
This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.
Study population:
All primipara full term women with episiotomy done in a selective rather than liberal use.
E- Patients in the study will be randomized into one of two groups either those who have:
- Interrupted technique of episiotomy repair or
- Continuous knotless suturing technique and each of the two groups will be subdivided into either medio-lateral or lateral episiotomy.
The Episiotomy in group A will be done using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.
The Episiotomy in group B will be done using the continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants.
And subgroups subjected to Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut. And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity.
The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0, Manufacturer TAISIER-MED Company).
F- Written informed consent will be taken from all women participating in our search.
G- Data recording: age,weight,height,body mass index,type of anesthesia used,type of episiotomy,time taken,infection or gaped episiotomy, amount of bleeding, postpartum hemorrhage,amount of suture material used,amount of analgesia used, severity of pain detected by VAS.
H- all patient will be given oral nonnarcotic analgesics (NSAIDs eg; ibuprofen 600 mg every eight hours for three days , if NSAIDs is contraindicated acetaminophen/ paracetamol 500 mg every eight hours for three days.
I- Antibiotic prophylaxis will be given as a single dose of a broad spectrum antibiotic (second generation cephalosporin or clindamycin if the patient is allergic to penicillin
- Conditions
- Episiotomy Wound
- Being tested
- repair of episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of episiotomyProcedure or surgery
Different techniques for repair of episiotomy incsicion
| Study group | Role | What they receive |
|---|---|---|
| interrupted repair of mediolateral episiotomy | Other | using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.
The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut Receives: Procedure: repair of episiotomy |
| continous repair of mediolateral episiotomy | Other | continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 Receives: Procedure: repair of episiotomy |
| interrupted repair of lateral episiotomy | Other | using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.
The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity Receives: Procedure: repair of episiotomy |
| continuous repair of lateral episiotomy | Other | continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 Receives: Procedure: repair of episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
using visual analogue scale
Measured: 6 hours
Secondary outcomes (5)
Postoperative pain two monthes after delivery.
using VAS
Measured: TWO MONTHS
Time taken in repair (min)
Measured: 1 hour
Number of suture ampoules used.
Measured: 1 hour
Dyspareunia
Dyspareunia reported up to two months after delivery (ACOG;1995). according to Marinoff dyspareunia scale:
0 = no dyspareunia;
- = causes discomfort, but does not interfere with the frequency of intercourse;
- = sometimes prevents intercourse; and
- = completely prevents intercourse.
Measured: two months
Early complication of episiotomy eg; anal spincter injury, rectal mucosal injury, bleeding or heamatoma formation.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start15 Jul 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
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 Ain Shams 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed mahmoud samy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486132
- Sponsor's protocol ID
- EPI
- Status last verified
- Mar 2018
- First submitted
- 25 Apr 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Interrupted Suturing In Repair of Lateral And Mediolateral Episiotomy
- ClinicalTrials.gov ID
- NCT03486132
- Acronym / sponsor ID
- EPI
- Conditions
- Episiotomy Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 3 Apr 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.
Episiotomy is an incision in the perineum carried out during the second stage of labour to facilitate the birth of an infant. It is an important surgical procedure with physiological, psychological and socio-economic effects on women. Therefore, not only the decision to carry out an episiotomy but also how it is performed and the quality of aftercare are important The two most often performed are the lateral and median episiotomy, as well as mediolateral episiotomy.
Two common methods of repair of episiotomy include continuous and interrupted methods This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.
Detailed description
Aim of the work:
This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.
Study population:
All primipara full term women with episiotomy done in a selective rather than liberal use.
E- Patients in the study will be randomized into one of two groups either those who have:
- Interrupted technique of episiotomy repair or
- Continuous knotless suturing technique and each of the two groups will be subdivided into either medio-lateral or lateral episiotomy.
The Episiotomy in group A will be done using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.
The Episiotomy in group B will be done using the continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants.
And subgroups subjected to Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut. And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity.
The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0, Manufacturer TAISIER-MED Company).
F- Written informed consent will be taken from all women participating in our search.
G- Data recording: age,weight,height,body mass index,type of anesthesia used,type of episiotomy,time taken,infection or gaped episiotomy, amount of bleeding, postpartum hemorrhage,amount of suture material used,amount of analgesia used, severity of pain detected by VAS.
H- all patient will be given oral nonnarcotic analgesics (NSAIDs eg; ibuprofen 600 mg every eight hours for three days , if NSAIDs is contraindicated acetaminophen/ paracetamol 500 mg every eight hours for three days.
I- Antibiotic prophylaxis will be given as a single dose of a broad spectrum antibiotic (second generation cephalosporin or clindamycin if the patient is allergic to penicillin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| interrupted repair of mediolateral episiotomy | Other | Procedure: repair of episiotomyusing the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin. The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut |
| continous repair of mediolateral episiotomy | Other | Procedure: repair of episiotomycontinuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 |
| interrupted repair of lateral episiotomy | Other | Procedure: repair of episiotomyusing the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin. The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity |
| continuous repair of lateral episiotomy | Other | Procedure: repair of episiotomycontinuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primipara women.
- Fullterm pregnancy.
- Lateral or mediolateral episiotomy done in selective rather than liberal episiotomy.
Key exclusion criteria (8 listed)
- Risk factor of trauma eg; macrosomia, congenital fetal malformations as (exophthalmous major, hydrocephalus, spinal cord teratoma….etc.
- Instrumental delivery.
- Primipara refuses to be in the study.
- Other techniques of episiotomy.
- Preterm onset of labour.
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 |
|---|---|---|
| repair of episiotomyDifferent techniques for repair of episiotomy incsicion | Procedure or surgery | continous repair of mediolateral episiotomy, continuous repair of lateral episiotomy, interrupted repair of lateral episiotomy, interrupted repair of mediolateral episiotomy |
Primary outcome
postoperative pain
Time frame: 6 hours
using visual analogue scale
5 secondary outcomes
Postoperative pain two monthes after delivery.
Time frame: TWO MONTHS
Time taken in repair (min)
Time frame: 1 hour
Number of suture ampoules used.
Time frame: 1 hour
Dyspareunia
Time frame: two months
Early complication of episiotomy eg; anal spincter injury, rectal mucosal injury, bleeding or heamatoma formation.
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repair of episiotomy in people with Episiotomy Wound, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 8 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 3 Apr 2018. 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 Egypt. 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 Mohamed Samy, MD (01001947488, mohammedsamy8132@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 6 hours). 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 3 Apr 2018.