The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain

NCT ID: NCT06379048

Last Updated: 2025-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Labor; Prolonged, Second Stage Episiotomy Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M-Suture

Episiotomy repair is completed until the skin closure. Interrupted mattress suturing technique is applied to this arm.

Group Type ACTIVE_COMPARATOR

Mattress Suturing

Intervention Type PROCEDURE

Horizontal mattress suture in interrupted fashion

I-Suture

Episiotomy repair is completed until the skin closure. Interrupted primary suturing technique is applied to this arm.

Group Type ACTIVE_COMPARATOR

Primary Suturing

Intervention Type PROCEDURE

Horizontal primary suture in interrupted fashion

SC-Suture

Episiotomy repair is completed until the skin closure. Continuous subcutaneous suturing technique is applied to this arm.

Group Type ACTIVE_COMPARATOR

Continuous Subcutaneous Suturing

Intervention Type PROCEDURE

Subcutaneous suture in continuous fashion

Interventions

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Mattress Suturing

Horizontal mattress suture in interrupted fashion

Intervention Type PROCEDURE

Primary Suturing

Horizontal primary suture in interrupted fashion

Intervention Type PROCEDURE

Continuous Subcutaneous Suturing

Subcutaneous suture in continuous fashion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primiparous
* Age between 18 to 45
* Given birth in our labor ward

Exclusion Criteria

* Multiparous
* having deep vaginal lacerations
* having abnormalities in fetus
* Rheumatologic diseases
* Postpartum bleeding
* Shoulder Dystocia
* Operative Delivery
* Using antithrombotic or anticoagulant medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Emre Kar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cam and Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 40323943 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2021.12.282

Identifier Type: -

Identifier Source: org_study_id

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