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

NCT06379048 | Completed Results

• 1 other identifier: 2021.12.282
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor; Prolonged, Second Stage; Episiotomy Wound

Keywords

Labor; Vaginal Birth; Episiotomy; Suturing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

M-Suture

ACTIVE COMPARATOR

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

Procedure: Mattress Suturing

I-Suture

ACTIVE COMPARATOR

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

Procedure: Primary Suturing

SC-Suture

ACTIVE COMPARATOR

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

Procedure: Continuous Subcutaneous Suturing

Interventions

Mattress Suturing PROCEDURE

Horizontal mattress suture in interrupted fashion

M-Suture

Primary Suturing PROCEDURE

Horizontal primary suture in interrupted fashion

I-Suture

Continuous Subcutaneous Suturing PROCEDURE

Subcutaneous suture in continuous fashion

SC-Suture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Cam and Sakura City Hospital

Istanbul, Basaksehir, 34494, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40323943 RESULT

Results Point of Contact

• Title: Dr. Emre Kar
• Organization: Çam and Sakura City Hospital

emre.kar@sbu.edu.tr

+90 (0212) 909 60 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 20, 2022
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be available upon request for at least 2 years after publication.
• Access Criteria: Contact with Corresponding Author

Locations

TU (1)