EpisiotomyNCT07383623
THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN
A study testing stapler skin closure and absorbable suture group in people with Episiotomy, run by Ayşegül Kanık at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy
- What is being tested?
- stapler skin closure and absorbable suture group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Demokrasi Universitesi Buca Seyfi Demirsoy Egitim ve Arastirma Hastanesi
Izmir, İzmir, 35000
Aysegul Kanik, MSc, 05308285953, ayseglkrt82@gmail.com
About this study
Official title: THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL
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.
Read the 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.
- Conditions
- Episiotomy
- Being tested
- stapler skin closure, absorbable suture group
- Keywords
- episiotomy, stapler, primiparous women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapler skin closureDevice
skin closure of episiotomy is performed using a surgical stapler.
absorbable suture groupProcedure or surgery
skin closure of episiotomy is performed using absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| stapler skin closure group | Experimental | Episiotomy repair is performed using surgical staplers for skin closure in primiparous women. Receives: Device: stapler skin closure |
| Absorbable suture group | Experimental | Skin closure of episiotomy is performed using absorbable sutures. Receives: Procedure: absorbable suture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 hours, 24 hours and 7 days postpartum
Secondary outcomes (1)
Episiotomy wound healing
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)
Measured: 10 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Oct 2025
- Primary completion1 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Primiparous women are randomly assigned to one of two parallel groups to undergo episiotomy repair with either stapler or absorbable skin sutures.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayşegül Kanık
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşegül Kanık, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383623
- Sponsor's protocol ID
- THESIS-EPIS-PAIN-2025
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and ethical considerations.
Publications
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.
Swenson CW, Low LK, Kowalk KM, Fenner DE. Randomized Trial of 3 Techniques of Perineal Skin Closure During Second-Degree Perineal Laceration Repair. J Midwifery Womens Health. 2019 Sep;64(5):567-577. doi: 10.1111/jmwh.13020. Epub 2019 Aug 21.
PubMed 31433108Woldegeorgis BZ, Obsa MS, Tolu LB, Bogino EA, Boda TI, Alemu HB. Episiotomy Practice and Its Associated Factors in Africa: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Jun 24;9:905174. doi: 10.3389/fmed.2022.905174. eCollection 2022.
PubMed 35865171Sherif, 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.
Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.
PubMed 29235159JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24.
PubMed 25999621Mastud K, Lamture Y, Nagtode T, Rewale V. A Comparative Study Between Conventional Sutures, Staples, and Adhesive Glue for Clean Elective Surgical Skin Closure. Cureus. 2022 Nov 7;14(11):e31196. doi: 10.7759/cureus.31196. eCollection 2022 Nov.
PubMed 36505125Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.
PubMed 23262925Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.
PubMed 25089271Correa Junior MD, Passini Junior R. Selective Episiotomy: Indications, Techinique, and Association with Severe Perineal Lacerations. Rev Bras Ginecol Obstet. 2016 Jun;38(6):301-7. doi: 10.1055/s-0036-1584942. Epub 2016 Jul 11.
PubMed 27399925Deyaso ZF, Chekole TT, Bedada RG, Molla W, Uddo EB, Mamo TT. Prevalence of episiotomy practice and factors associated with it in Ethiopia, systematic review and meta-analysis. Womens Health (Lond). 2022 Jan-Dec;18:17455057221091659. doi: 10.1177/17455057221091659.
PubMed 35435068Chang SR, Chen KH, Lin HH, Chao YM, Lai YH. Comparison of the effects of episiotomy and no episiotomy on pain, urinary incontinence, and sexual function 3 months postpartum: a prospective follow-up study. Int J Nurs Stud. 2011 Apr;48(4):409-18. doi: 10.1016/j.ijnurstu.2010.07.017.
PubMed 20800840Chamariya, 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.
Akopov A, Artioukh DY, Molnar TF. Surgical Staplers: The History of Conception and Adoption. Ann Thorac Surg. 2021 Nov;112(5):1716-1721. doi: 10.1016/j.athoracsur.2021.03.107. Epub 2021 Apr 24.
PubMed 33905724Beşen, M. A., & Rathfısch, G. (2019). Doğumda Perineal Travma ve Onarımı: Kanıt Temelli Yaklaşımlar. Gazi Sağlık Bilimleri Dergisi, 4(3), 1-11.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF STAPLER VERSUS SKIN SUTURING ON PAIN AND WOUND HEALING AFTER EPISIOTOMY REPAIR IN PRIMIPAROUS WOMEN: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07383623
- Acronym / sponsor ID
- THESIS-EPIS-PAIN-2025
- Conditions
- Episiotomy
- Keywords
- episiotomy, stapler, primiparous women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ayşegül KanıkUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Primiparous women are randomly assigned to one of two parallel groups to undergo episiotomy repair with either stapler or absorbable skin sutures.
| Arm | Type | Receives |
|---|---|---|
| stapler skin closure group | Experimental | Device: stapler skin closureEpisiotomy repair is performed using surgical staplers for skin closure in primiparous women. |
| Absorbable suture group | Experimental | Procedure: absorbable suture groupSkin closure of episiotomy is performed using absorbable sutures. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stapler skin closureskin closure of episiotomy is performed using a surgical stapler. | Device | stapler skin closure group |
| absorbable suture groupskin closure of episiotomy is performed using absorbable sutures. | Procedure or surgery | Absorbable suture group |
Primary outcome
postpartum perineal pain
Time frame: 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.
1 secondary outcome
Episiotomy wound healing
Time frame: 10 days postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- BackgroundTeixeira, 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: PubMed 31433108Swenson CW, Low LK, Kowalk KM, Fenner DE. Randomized Trial of 3 Techniques of Perineal Skin Closure During Second-Degree Perineal Laceration Repair. J Midwifery Womens Health. 2019 Sep;64(5):567-577. doi: 10.1111/jmwh.13020. Epub 2019 Aug 21.
- Background: PubMed 35865171Woldegeorgis BZ, Obsa MS, Tolu LB, Bogino EA, Boda TI, Alemu HB. Episiotomy Practice and Its Associated Factors in Africa: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Jun 24;9:905174. doi: 10.3389/fmed.2022.905174. eCollection 2022.
- BackgroundSherif, 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: PubMed 29235159Shahrahmani H, Kariman N, Jannesari S, Rafieian-Kopaei M, Mirzaei M, Ghalandari S, Shahrahmani N, Mardani G. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res. 2018 Mar;32(3):522-530. doi: 10.1002/ptr.5999. Epub 2017 Dec 13.
- Background: PubMed 25999621JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24.
- Background: PubMed 36505125Mastud K, Lamture Y, Nagtode T, Rewale V. A Comparative Study Between Conventional Sutures, Staples, and Adhesive Glue for Clean Elective Surgical Skin Closure. Cureus. 2022 Nov 7;14(11):e31196. doi: 10.7759/cureus.31196. eCollection 2022 Nov.
- Background: PubMed 23262925Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.
- Background: PubMed 25089271Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.
- Background: PubMed 27399925Correa Junior MD, Passini Junior R. Selective Episiotomy: Indications, Techinique, and Association with Severe Perineal Lacerations. Rev Bras Ginecol Obstet. 2016 Jun;38(6):301-7. doi: 10.1055/s-0036-1584942. Epub 2016 Jul 11.
- Background: PubMed 35435068Deyaso ZF, Chekole TT, Bedada RG, Molla W, Uddo EB, Mamo TT. Prevalence of episiotomy practice and factors associated with it in Ethiopia, systematic review and meta-analysis. Womens Health (Lond). 2022 Jan-Dec;18:17455057221091659. doi: 10.1177/17455057221091659.
- Background: PubMed 20800840Chang SR, Chen KH, Lin HH, Chao YM, Lai YH. Comparison of the effects of episiotomy and no episiotomy on pain, urinary incontinence, and sexual function 3 months postpartum: a prospective follow-up study. Int J Nurs Stud. 2011 Apr;48(4):409-18. doi: 10.1016/j.ijnurstu.2010.07.017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and ethical considerations.
Related trials for Episiotomy
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Active, not recruitingObservational study
Novosyn® Quick in Patients Undergoing Episiotomy Closure
Episiotomy Wound
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
Model-Based Episiotomy Training
Episiotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stapler skin closure and absorbable suture group in people with Episiotomy, run by Ayşegül Kanık at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysegul Kanik, MSc (+905308285953, ayseglkrt82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postpartum perineal pain (time frame: At 6 hours, 24 hours and 7 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07383623, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.