Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
NCT07383623

THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN

Led by Ayşegül Kanık · Updated on 2026-02-10

24

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled study aims to evaluate the effects of skin closure using surgical staplers compared with conventional skin sutures on postoperative pain and wound healing in primiparous women undergoing episiotomy repair after vaginal delivery. Primiparous women who require episiotomy during vaginal birth will be randomly assigned to one of two groups: skin closure with staples or skin closure with sutures. Postpartum pain levels and wound healing outcomes will be assessed and compared between the two groups. The results of this study are expected to contribute to evidence-based decisions regarding optimal skin closure techniques in episiotomy repair.

CONDITIONS

Official Title

THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN

Who Can Participate

Age: 18Years - 49Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Term pregnancy of 37 weeks or more
  • Low-risk pregnancy without obstetric risk factors
  • Not receiving oxytocin induction during latent or active labor
  • Singleton pregnancy with a live fetus
  • No psychiatric disorders
  • No substance abuse
  • Primiparous women having their first vaginal birth
  • Presence of 1st or 2nd degree perineal tear
  • Able to read, understand, and voluntarily provide written and verbal informed consent
Not Eligible

You will not qualify if you...

  • Apgar score less than 7 at 1 minute and/or 5 minutes
  • Neonatal anomaly
  • Use of more than 10 mL analgesic during episiotomy repair beyond routine practice
  • Obesity
  • Vaginal infection or vaginal lesion
  • Maternal conditions impairing wound healing such as diabetes mellitus, immunosuppression, or coagulation disorders
  • 3rd or 4th degree perineal tear
  • Shoulder dystocia or difficult delivery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi

Izmir, İzmir, Turkey (Türkiye), 35000

Actively Recruiting

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Research Team

A

Aysegul Kanik, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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