Episiotomy WoundNCT03611452
Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears
A study testing Episiotomy in people with Episiotomy Wound, run by Assiut University.
Trial summary
Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing. The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Episiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Mar 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Normal vaginal delivery.
- At term (37 40 weeks ).
- Live baby.
- Vertex presentation
Who cannot join
- Third and fourth degree perineal tear.
- Instrumental vaginal delivery.
- Previous perineal surgery.
- Anaemia with hemoglobin level < 9 g/dl.
- Diabetes mellitus.
- Coagulation abnormalities.
Show all 12Show fewer
- Postpartum hemorrhage.
- Delivery conducted outside Woman HealthHospital.
- Breech delivery.
- Body mass index >35 kg/m2.
- Local infectious lesions.
- Anal fissures or hemorrhoid.
About this study
Official title: Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study
Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.
The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure
- Conditions
- Episiotomy Wound
- Being tested
- Episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpisiotomyProcedure or surgery
repair of perineal muscles and skin
| Study group | Role | What they receive |
|---|---|---|
| Simple continuous | Experimental | the sutures will be taken continuously by simple method Receives: Procedure: Episiotomy |
| subcuticular | Active comparator | the sutures will be taken subcuticular Receives: Procedure: Episiotomy |
| interrupted | Active comparator | the sutures will be taken interrupted method Receives: Procedure: Episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean score of Perineal pain during vaginal suturing
assessment through visual analog scale score from 0 - 10 at every step of repair
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (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 Assiut 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611452
- Sponsor's protocol ID
- SCIE
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 2 Aug 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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study
- ClinicalTrials.gov ID
- NCT03611452
- Acronym / sponsor ID
- SCIE
- Conditions
- Episiotomy Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 2 Aug 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.
Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.
The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple continuous | Experimental | Procedure: Episiotomythe sutures will be taken continuously by simple method |
| subcuticular | Active comparator | Procedure: Episiotomythe sutures will be taken subcuticular |
| interrupted | Active comparator | Procedure: Episiotomythe sutures will be taken interrupted method |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Normal vaginal delivery.
- At term (37 40 weeks ).
- Live baby.
- Vertex presentation
Key exclusion criteria (12 listed)
- Third and fourth degree perineal tear.
- Instrumental vaginal delivery.
- Previous perineal surgery.
- Anaemia with hemoglobin level < 9 g/dl.
- Diabetes mellitus.
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 |
|---|---|---|
| Episiotomyrepair of perineal muscles and skin | Procedure or surgery | Simple continuous, interrupted, subcuticular |
Primary outcome
the mean score of Perineal pain during vaginal suturing
Time frame: 10 minutes
assessment through visual analog scale score from 0 - 10 at every step of repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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 study testing Episiotomy in people with Episiotomy Wound, run by Assiut 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 4 inclusion and 12 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 2 Aug 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.
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?
the mean score of Perineal pain during vaginal suturing (time frame: 10 minutes). 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 Aug 2018.