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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-Suture | Active Comparator | Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm. |
|
| I-Suture | Active Comparator | Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm. |
|
| SC-Suture | Active Comparator | Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mattress Suturing | Procedure | Horizontal mattress suture in interrupted fashion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | in postpartum day 15 |
| Pain by Visual Analog Scale (VAS) | Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS) | in postpartum day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cam and Sakura City Hospital | Istanbul | Basaksehir | 34494 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40323943 | Result | 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. |
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IPD will be available upon request for at least 2 years after publication.
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IPD will be available upon request for at least 2 years after publication.
Contact with Corresponding Author
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| ID | Title | Description |
|---|---|---|
| FG000 | M-Suture | Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm. Mattress Suturing: Horizontal mattress suture in interrupted fashion |
| FG001 | I-Suture | Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm. Primary Suturing: Horizontal primary suture in interrupted fashion |
| FG002 | SC-Suture | Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | M-Suture | Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm. Mattress Suturing: Horizontal mattress suture in interrupted fashion |
| BG001 | I-Suture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Full Range | REEDA Score | in postpartum day 15 |
|
15 days
Episiotomy repair is a relatively simple procedure and is not typically associated with life-threatening mortality or long-term morbidity that would significantly impact quality of life. The most significant potential morbidity is related to anal sphincter injury; however, patients with such injuries were not included in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M-Suture | Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm. Mattress Suturing: Horizontal mattress suture in interrupted fashion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehiscense | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emre Kar | Çam and Sakura City Hospital | +90 (0212) 909 60 00 | 11250 | emre.kar@sbu.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | May 23, 2025 | Prot_SAP_000.pdf |
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| Primary Suturing |
| Procedure |
Horizontal primary suture in interrupted fashion |
|
| Continuous Subcutaneous Suturing | Procedure | Subcutaneous suture in continuous fashion |
|
Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.
Primary Suturing: Horizontal primary suture in interrupted fashion
| BG002 | SC-Suture | Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Gestational Age at Delivery | Mean | Standard Deviation | weeks |
|
| Labor Induction | Count of Participants | Participants |
|
| Active Birth Phase Duration (hours) | Mean | Standard Deviation | hours |
|
| OG002 | SC-Suture | Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion |
|
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| Primary | Pain by Visual Analog Scale (VAS) | Pain is assessed from 0 (none) to 10 (extreme) by Visual Analog Scale (VAS) | Posted | Median | Full Range | VAS Score | in postpartum day 15 |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 4 |
| 43 |
| EG001 | I-Suture | Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm. Primary Suturing: Horizontal primary suture in interrupted fashion | 0 | 43 | 0 | 43 | 2 | 43 |
| EG002 | SC-Suture | Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm. Continuous Subcutaneous Suturing: Subcutaneous suture in continuous fashion | 0 | 43 | 0 | 43 | 3 | 43 |
| Urinary Incontinence | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Fecal Incontinence | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| Male |
|