EpisiotomyPhase 3NCT03780530
Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
A Phase 3 study testing subcuticular suturing, Surgical glue and adhesive steri-strip tape in people with Episiotomy, run by Ain Shams University.
Trial summary
this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy
- What is being tested?
- subcuticular suturing, Surgical glue and adhesive steri-strip tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Dec 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged above 18 yrs.
- Primiparous.
- Undergoing spontaneous vaginal delivery of a single full-term fetus.
- Vertex presentation.
- Having mediolateral episiotomy.
Who cannot join
- Body mass index ≥ 35 kg/m2
- Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
- Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
- The use of epidural anesthesia.
- Previous perineal surgeries, local infection or lesions.
- Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression).
- Contraindication or Hypersensitivity to any of materials used in the study.
About this study
Official title: Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair
- Conditions
- Episiotomy
- Being tested
- subcuticular suturing, Surgical glue, adhesive steri-strip tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcuticular suturingProcedure or surgery
Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).
Surgical glueProcedure or surgery
Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).
adhesive steri-strip tapeProcedure or surgery
Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).
| Study group | Role | What they receive |
|---|---|---|
| subcuticular suturing | Active comparator | Not described Receives: Procedure: subcuticular suturing |
| surgical glue | Active comparator | Not described Receives: Procedure: Surgical glue |
| adhesive steri-strip tape | Active comparator | Not described Receives: Procedure: adhesive steri-strip tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short -term postpartum pain
Post-operative perineal pain will be evaluated at 6 hrs after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
Measured: six hours postpartum
Short -term postpartum pain
Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
Measured: 10 days postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780530
- Sponsor's protocol ID
- Ain shams maternity U
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
- ClinicalTrials.gov ID
- NCT03780530
- Acronym / sponsor ID
- Ain shams maternity U
- Conditions
- Episiotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 19 Dec 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.
this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subcuticular suturing | Active comparator | Procedure: subcuticular suturing |
| surgical glue | Active comparator | Procedure: Surgical glue |
| adhesive steri-strip tape | Active comparator | Procedure: adhesive steri-strip tape |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged above 18 yrs.
- Primiparous.
- Undergoing spontaneous vaginal delivery of a single full-term fetus.
- Vertex presentation.
- Having mediolateral episiotomy.
Key exclusion criteria (7 listed)
- Body mass index ≥ 35 kg/m2
- Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
- Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
- The use of epidural anesthesia.
- Previous perineal surgeries, local infection or lesions.
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 |
|---|---|---|
| subcuticular suturingThose undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®). | Procedure or surgery | subcuticular suturing |
| Surgical glueThose undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®). | Procedure or surgery | surgical glue |
| adhesive steri-strip tapeThose undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes). | Procedure or surgery | adhesive steri-strip tape |
Primary outcome
Short -term postpartum pain
Time frame: six hours postpartum
Post-operative perineal pain will be evaluated at 6 hrs after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
Short -term postpartum pain
Time frame: 10 days postnatal
Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing subcuticular suturing, Surgical glue and adhesive steri-strip tape in people with Episiotomy, run by Ain Shams University.
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 5 inclusion and 7 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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Short -term postpartum pain (time frame: six hours postpartum). 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 20 Dec 2018.