NCT07383623

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 26, 2026

Last Update Submit

February 6, 2026

Conditions

Episiotomy

Keywords

episiotomystaplerprimiparous women

Outcome Measures

Primary Outcomes (1)

  • postpartum perineal pain

    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.

    At 6 hours, 24 hours and 7 days postpartum

Secondary Outcomes (1)

  • Episiotomy wound healing

    10 days postpartum

Study Arms (2)

stapler skin closure group

EXPERIMENTAL

Episiotomy repair is performed using surgical staplers for skin closure in primiparous women.

Device: stapler skin closure

Absorbable suture group

EXPERIMENTAL

Skin closure of episiotomy is performed using absorbable sutures.

Procedure: absorbable suture group

Interventions

stapler skin closureDEVICE

skin closure of episiotomy is performed using a surgical stapler.

stapler skin closure group
absorbable suture groupPROCEDURE

skin closure of episiotomy is performed using absorbable sutures.

Absorbable suture group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes primiparous women who have undergone vaginal delivery with mediolateral episiotomy.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify 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
  • 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.

You may not qualify 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)
  • rd or 4th degree perineal tear
  • Shoulder dystocia / difficult delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi

Izmir, İzmir, 35000, Turkey (Türkiye)

RECRUITING

Related Publications (15)

  • Teixeira, T. T., Caroci-Becker, A., Brunelli, W. S., & Riesco, M. L. G. (2020). Tissue Adhesive To Repair First-Degree Perineal Tear: A Pilot Randomized Controlled Trial. Clinical And Experimental Obstetrics And Gynecology, 47(2), 228-233.

    BACKGROUND

  • Swenson, C. W., Low, L. K., Kowalk, K. M., & Fenner, D. E. (2019). Randomized Trial Of 3 Techniques Of Perineal Skin Closure During Second-Degree Perineal Laceration Repair. Journal Of Midwifery & Women's Health, 64(5), 567-577.

    BACKGROUND

  • Woldegeorgis, B. Z., Obsa, M. S., Tolu, L. B., Bogino, E. A., Boda, T. I., & Alemu, H. B. (2022). Episiotomy Practice and Its Associated Factors in Africa: A Systematic Review and Meta-Analysis. Frontiers in Medicine, 1714.

    BACKGROUND

  • Sherif, A., & El-Shourbagy, M. (2020). Skin-Adhesive Tape Versus Interrupted Suture İn Episiotomy Skin Repair: Randomized Control Trial. Open Journal Of Obstetrics And Gynecology, 10(02), 254.

    BACKGROUND

  • Shahrahmani, H., Kariman, N., Jannesari, S., Rafieian-Kopaei, M., Mirzaei, M., Ghalandari, S., ... & Mardani, G. (2018). The Effect Of Green Tea Ointment On Episiotomy Pain And Wound Healing in Primiparous Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Phytotherapy Research, 32(3), 522-530.

    BACKGROUND

  • JahaniShoorab, N., Zagami, S. E., Nahvi, A., Mazluom, S. R., Golmakani, N., Talebi, M., & Pabarja, F. (2015). The effect of virtual reality on pain in primiparity women during episiotomy repair: a randomize clinical trial. Iranian journal of medical sciences, 40(3), 219.

    BACKGROUND

  • Mastud, K., Lamture, Y., Nagtode, T., & Rewale, V. (2022). A Comparative Study Between Conventional Sutures, Staples, And Adhesive Glue For Clean Elective Surgical Skin Closure. Cureus, 14(11).

    BACKGROUND

  • Figueroa, D., Jauk, V. C., Szychowski, J. M., Garner, R., Biggio, J. R., Andrews, W. W., ... & Tita, A. T. (2013). Surgical Staples Compared With Subcuticular Suture For Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstetrics And Gynecology, 121(1).

    BACKGROUND

  • Feigenberg, T., Maor-Sagie, E., Zivi, E., Abu-Dia, M., Ben-Meir, A., Sela, H. Y., & Ezra, Y. (2014). Using Adhesive Glue To Repair First Degree Perineal Tears: A Prospective Randomized Controlled Trial. Biomed Research International, 2014.

    BACKGROUND

  • Corrêa, M. D., & Passini, R. (2016). Selective episiotomy: indications, techinique, and association with severe perineal lacerations. Revista Brasileira de Ginecologia e Obstetrícia, 38(06), 301-307.

    BACKGROUND

  • Deyaso, Z. F., Chekole, T. T., Bedada, R. G., Molla, W., Uddo, E. B., & Mamo, T. T. (2022). Prevalence of Episiotomy Practice and Factors Associated with it in Ethiopia, Systematic Review and Meta-analysis. Women's Health, 18, 17455057221091659.

    BACKGROUND

  • Chang, S. R., Chen, K. H., Lin, H. H., Chao, Y. M. Y., & Lai, Y. H. (2011). Comparison Of The Effects Of Episiotomy And No Episiotomy On Pain, Urinary İncontinence, And Sexual Function 3 Months Postpartum: A Prospective Follow-Up Study. International Journal Of Nursing Studies, 48(4), 409-418.

    BACKGROUND

  • Chamariya, S., Prasad, M., & Chauhan, A. (2016). Comparison Of Dermabond Adhesive Glue With Skin Suture For Repair Of Episiotomy. International Journal Of Reproduction, Contraception, Obstetrics And Gynecology, 5(10), 3461-3466.

    BACKGROUND

  • Akopov, A., Artioukh, D. Y., & Molnar, T. F. (2021). Surgical Staplers: The History Of Conception And Adoption. The Annals Of Thoracic Surgery, 112(5), 1716-1721.

    BACKGROUND

  • Beşen, M. A., & Rathfısch, G. (2019). Doğumda Perineal Travma ve Onarımı: Kanıt Temelli Yaklaşımlar. Gazi Sağlık Bilimleri Dergisi, 4(3), 1-11.

    BACKGROUND

Central Study Contacts

Aysegul Kanik, MSc

CONTACT

+905308285953ayseglkrt82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Primiparous women are randomly assigned to one of two parallel groups to undergo episiotomy repair with either stapler or absorbable skin sutures.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MIDWIFE

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

October 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient confidentiality and ethical considerations.

Locations

TU(1)