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

RecruitingNAAges 18 Years - 49 YearsFemaleAyşegül Kanık
NCT07383623 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Term pregnancy (≥ 37 weeks) * Low-risk pregnancy (no obstetric risk factors) * Not receiving oxytocin induction during latent or active labor * Singleton pregnancy with a live fetus * No psychiatric disorder * No substance abuse * Primiparous women (first vaginal birth) * Presence of 1st or 2nd degree perineal tear * Able to read, understand, and voluntarily provide written and verbal informed consent. Exclusion Criteria: * Apgar score \< 7 at 1 minute and/or 5 minutes * Neonatal anomaly * Use of \>10 mL analgesic during episiotomy repair beyond routine practice * Obesity * Vaginal infection or vaginal lesion * Maternal conditions impairing wound healing (e.g., diabetes mellitus, immunosuppression, coagulation disorders) * 3rd or 4th degree perineal tear * Shoulder dystocia / difficult delivery
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What it tests

  • stapler skin closure
  • absorbable suture group
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Where

1 site
Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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