NCT07383623 THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN
| NCT ID | NCT07383623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ayşegül Kanık |
| Condition | Episiotomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-10-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07383623 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Episiotomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07383623 currently recruiting?
Yes, NCT07383623 is actively recruiting participants. Contact the research team at ayseglkrt82@gmail.com for enrollment information.
Where is the NCT07383623 trial being conducted?
This trial is being conducted at Izmir, Turkey (Türkiye).
Who is sponsoring the NCT07383623 clinical trial?
NCT07383623 is sponsored by Ayşegül Kanık. The trial plans to enroll 24 participants.