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Compares treatment options for Episiotomy
Official title THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN
ClinicalTrials.gov ID: NCT07383623
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Izmir, İzmir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Izmir, İzmir, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.