Episiotomy
Conditions
Keywords
episiotomy, stapler, primiparous women
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.
Detailed description
Episiotomy is one of the most commonly performed obstetric interventions during childbirth. Although it shares similar characteristics with spontaneous second-degree perineal tears, episiotomy was routinely performed for many years. However, routine episiotomy practices began to be questioned in the late 1970s and 1980s, and its use declined during the 1990s. Factors contributing to this change include increased health awareness among women, the natural childbirth movement, professional competition, and the widespread adoption of evidence-based practices. Pain associated with episiotomy is a significant issue that negatively affects women's quality of life in the postpartum period. A woman's request for analgesia is considered a medical indication for pain management. Inadequate pain control reduces the effectiveness of therapeutic interventions. Episiotomy-related pain decreases maternal comfort, negatively affects mother-infant bonding, reduces breastfeeding success, and may even influence women's childbirth preferences due to fear of labor and episiotomy pain. The ideal method for episiotomy repair should be fast, easy to perform, cause minimal tissue trauma, and result in minimal postpartum pain and dyspareunia. Closure techniques that minimize skin trauma reduce inflammation and scarring by limiting the introduction of foreign materials. Various techniques have been proposed for postpartum episiotomy repair, including non-suturing of the incision, continuous locking sutures, and interrupted non-locking sutures. Regardless of the technique used, successful tissue approximation is associated with less pain and wound infection, better cosmetic outcomes, and shorter hospital stays. In recent years, traditional repair methods have increasingly been replaced by modern techniques such as skin staples, tissue adhesives, and adhesive strips. Skin staples, one of these modern methods, are described as a faster and more reliable repair technique. Due to their fixed depth and uniform structure, staples provide equal wound tension, which is thought to reduce pain and promote wound healing in episiotomy skin repair. The aim of this study is to determine the effects of using staples versus surgical sutures in episiotomy skin repair on postpartum localized pain and wound healing.
Interventions
PROCEDUREabsorbable suture group
skin closure of episiotomy is performed using absorbable sutures.
DEVICEstapler skin closure
skin closure of episiotomy is performed using a surgical stapler.
Sponsors
Ayşegül Kanık
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Primiparous women are randomly assigned to one of two parallel groups to undergo episiotomy repair with either stapler or absorbable skin sutures.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postpartum perineal pain | At 6 hours, 24 hours and 7 days postpartum | Perineal pain severity will be assessed using the Visual Analog Scale (VAS) following episiotomy repair. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episiotomy wound healing | 10 days postpartum | Wound healing will be assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation). The total REEDA score ranges from 0 to 15, with lower scores indicating better wound healing and higher scores indicating worse wound healing.Wound healing assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation) |
Countries
Turkey (Türkiye)
Contacts
CONTACTAysegul Kanik, MSc
Outcome results
None listed