Staples versus stitches for closing episiotomy wounds in first-time mothers
Official title: THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL
Run by Ege University · NCT07383623 · Data updated 2026-11-12
This test will see if using surgical staples instead of stitches to close an episiotomy reduces postpartum pain and improves wound healing for first-time mothers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 49 Years |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir, İzmir) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07383623 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are primiparous women aged 18 or older with a term, low-risk singleton pregnancy who require a first- or second-degree episiotomy and can deliver and follow up at the study hospital.
✕Probably not a fit
Women with third- or fourth-degree tears, obesity, active vaginal infection, conditions that impair wound healing (for example diabetes or immunosuppression), neonatal complications, or complicated deliveries are unlikely to benefit from the interventions tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll primiparous women who require an episiotomy during vaginal delivery and randomly assign them to skin closure with surgical staples or with absorbable sutures. Postpartum pain will be measured with standardized pain scales and analgesic use, and wound healing will be assessed during scheduled postpartum visits. Women with major (3rd/4th degree) tears, conditions that impair wound healing, or complicated deliveries are excluded. The trial compares short-term pain and wound recovery between the two closure techniques to guide clinical decisions about episiotomy repair.
Why it matters
Potential benefit: If successful, using staples could reduce postpartum pain and speed wound recovery, improving comfort and early maternal-infant interactions.
How similar studies have gone: Previous small trials and surgical literature comparing staples and sutures for skin or perineal closure have shown mixed results, so the approach is not yet conclusively proven for episiotomy repair.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
Izmir, İzmir, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Aysegul Kanik, MSc
- Email: ayseglkrt82@gmail.com
- Phone: +905308285953
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery
This will test whether pelvic floor muscle exercises plus cryotherapy started right after birth reduce perineal pain for first-time mothers who had a grade 2 or higher tear or an episiotomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.