Labor; Prolonged, Second StageNCT06379048
The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain
A study testing Mattress Suturing, Primary Suturing and Continuous Subcutaneous Suturing in people with Labor; Prolonged, Second Stage and Episiotomy Wound, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor; Prolonged, Second Stage, Episiotomy Wound
- What is being tested?
- Mattress Suturing, Primary Suturing and Continuous Subcutaneous Suturing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous
- Age between 18 to 45
- Given birth in our labor ward
Who cannot join
- Multiparous
- having deep vaginal lacerations
- having abnormalities in fetus
- Rheumatologic diseases
- Postpartum bleeding
- Shoulder Dystocia
- Operative Delivery
- Using antithrombotic or anticoagulant medications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cam and Sakura City Hospital
Istanbul, Basaksehir, 34494
About this study
Official title: The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain: A Randomized Clinical Trial
Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.
- Conditions
- Labor; Prolonged, Second Stage, Episiotomy Wound
- Being tested
- Mattress Suturing, Primary Suturing, Continuous Subcutaneous Suturing
- Keywords
- Labor, Vaginal Birth, Episiotomy, Suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mattress SuturingProcedure or surgery
Horizontal mattress suture in interrupted fashion
Primary SuturingProcedure or surgery
Horizontal primary suture in interrupted fashion
Continuous Subcutaneous SuturingProcedure or surgery
Subcutaneous suture in continuous fashion
| Study group | Role | What they receive |
|---|---|---|
| M-Suture | Active comparator | Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm. Receives: Procedure: Mattress Suturing |
| I-Suture | Active comparator | Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm. Receives: Procedure: Primary Suturing |
| SC-Suture | Active comparator | Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. Receives: Procedure: Continuous Subcutaneous Suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
Healing is assessed by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
REEDA Scale:
Healed: 0; moderately healed: 1 to 5; mildly healed: 6 to 10; and not healed: 11 to 15
Measured: in postpartum day 15
Pain by Visual Analog Scale (VAS)
Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS)
Measured: in postpartum day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor; Prolonged, Second StageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Kar, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379048
- Sponsor's protocol ID
- 2021.12.282
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2024
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon request for at least 2 years after publication.
Publications
Yuksel S, Ustun A, Kar E, Ozcan A, Callioglu N. The impact of different skin Suture methods in episiotomy repair on healing and pain: A randomized clinical trial. Health Care Women Int. 2025;46(9):1015-1029. doi: 10.1080/07399332.2025.2499498. Epub 2025 May 5.
PubMed 40323943
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06379048
- Acronym / sponsor ID
- 2021.12.282
- Conditions
- Labor; Prolonged, Second Stage, Episiotomy Wound
- Keywords
- Labor, Vaginal Birth, Episiotomy, Suturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M-Suture | Active comparator | Procedure: Mattress SuturingEpisiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm. |
| I-Suture | Active comparator | Procedure: Primary SuturingEpisiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm. |
| SC-Suture | Active comparator | Procedure: Continuous Subcutaneous SuturingEpisiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primiparous
- Age between 18 to 45
- Given birth in our labor ward
Key exclusion criteria (8 listed)
- Multiparous
- having deep vaginal lacerations
- having abnormalities in fetus
- Rheumatologic diseases
- Postpartum bleeding
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 |
|---|---|---|
| Mattress SuturingHorizontal mattress suture in interrupted fashion | Procedure or surgery | M-Suture |
| Primary SuturingHorizontal primary suture in interrupted fashion | Procedure or surgery | I-Suture |
| Continuous Subcutaneous SuturingSubcutaneous suture in continuous fashion | Procedure or surgery | SC-Suture |
Primary outcome
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
Time frame: in postpartum day 15
Healing is assessed by Redness, Edema, Ecchymosis and Discharge (REEDA) Score REEDA Scale: Healed: 0; moderately healed: 1 to 5; mildly healed: 6 to 10; and not healed: 11 to 15
Pain by Visual Analog Scale (VAS)
Time frame: in postpartum day 15
Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40323943Yuksel S, Ustun A, Kar E, Ozcan A, Callioglu N. The impact of different skin Suture methods in episiotomy repair on healing and pain: A randomized clinical trial. Health Care Women Int. 2025;46(9):1015-1029. doi: 10.1080/07399332.2025.2499498. Epub 2025 May 5.
- Individual participant dataSharing planned: Yes. IPD will be available upon request for at least 2 years after publication.
Related trials for Labor; Prolonged, Second Stage
Recruiting
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery
Prolonged Second Stage of Labor
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 Mattress Suturing, Primary Suturing and Continuous Subcutaneous Suturing in people with Labor; Prolonged, Second Stage and Episiotomy Wound, run by Başakşehir Çam & Sakura City Hospital 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 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: finished, as of the sponsor's last update on 12 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score (time frame: in postpartum day 15). 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?
On the ClinicalTrials.gov record for NCT06379048, which also lists 1 linked publication.
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 12 Jun 2025.