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Clinical Trials/NCT06379048
NCT06379048
Completed
Not Applicable

The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain: A Randomized Clinical Trial

Başakşehir Çam & Sakura City Hospital1 site in 1 country132 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor; Prolonged, Second Stage
Sponsor
Başakşehir Çam & Sakura City Hospital
Enrollment
132
Locations
1
Primary Endpoint
Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
September 20, 2022
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Emre Kar

Principal Investigator

Başakşehir Çam & Sakura City Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Study Sites (1)

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