THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN P… (NCT07383623) | Clinical Trial Compass
RecruitingNot Applicable
THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN
Turkey (Türkiye)24 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
postpartum perineal pain
Timeframe: At 6 hours, 24 hours and 7 days postpartum