Caesarean SectionNCT07323355
Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness
A study testing Double-Layer Cesarean Scar Repair and Single-Layer Cesarean Scar Repair in people with Caesarean Section and Cesarean Scar Closure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with a rising incidence particularly in high-income countries. Although often life-saving, cesarean delivery carries both short- and long-term maternal risks. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section, Cesarean Scar Closure, Cesarean Scar Defect (Isthmococele)
- What is being tested?
- Double-Layer Cesarean Scar Repair and Single-Layer Cesarean Scar Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2025to 15 Nov 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 18-44 years.
- Undergoing cesarean delivery at the study hospital's Obstetrics and Gynecology clinic.
- Evaluated as clinically eligible based on history, physical examination, abdominal ultrasonography, and routine preoperative laboratory tests, including:
- Complete blood count (CBC), biochemical profile, prothrombin time (PT), activated partial thromboplastin time (aPTT), blood group determination. No abnormalities detected in the above assessments.
Who cannot join
- Presence of chronic diseases, including: Rheumatologic diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, thyroid disease, congenital hematologic disorders.
- Suspected or confirmed placenta previa or placenta accreta spectrum.
- Clinical chorioamnionitis.
- Anterior wall uterine myomas.
- History of low transverse nonstandard uterine incision.
- Predicted obstetric hemorrhage or other intraoperative complications.
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
Ankara Bilkent City Hospital
Ankara, Not Valid, 06100
Merve Didem Eşkin Tanrıverdi, MD, +903125526000, mrvddm@hotmail.com
About this study
Official title: Effects of Single-Layer Versus Double-Layer Cesarean Scar Repair on Myometrial Thickness and Associated Clinical Outcomes
Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with a rising incidence particularly in high-income countries. Although often life-saving, cesarean delivery carries both short- and long-term maternal risks. Early complications include infection, hemorrhage, and thromboembolism, while inadequate uterine healing can lead to future complications such as uterine rupture and placenta accreta spectrum disorders. Additionally, cesarean scars may result in pregnancy complications, isthmocele formation, postmenstrual bleeding, pelvic pain, and dysmenorrhea. This highlights the need for optimization of the surgical technique. Despite increasing cesarean rates, there is no consensus on the optimal uterine closure method. Techniques vary in terms of the number of layers, suture locking style, and inclusion of the endometrium, and their comparative effectiveness in reducing scar defects remains unclear. Some previous studies have reported increased uterine rupture risk with single-layer locked sutures and better healing with double-layer closure, while others found no significant difference in scar outcomes. This study aims to investigate the effects of single- versus double-layer cesarean scar closure on myometrial thickness and its clinical implications.
- Conditions
- Caesarean Section, Cesarean Scar Closure, Cesarean Scar Defect (Isthmococele), Myometrial Thickness, Postpartum Complications, Clinical Outcomes
- Being tested
- Double-Layer Cesarean Scar Repair, Single-Layer Cesarean Scar Repair
- Keywords
- Caesarean Section, Cesarean Scar Closure, Isthmococele, Myometrial Thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-Layer Cesarean Scar RepairProcedure or surgery
Participants in this arm undergo double-layer closure of the uterine incision during cesarean delivery. The procedure involves suturing the full thickness of the myometrium in the first layer, followed by a second continuous suture approximating the outer myometrium and serosa. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the single-layer cesarean scar repair arm.
Single-Layer Cesarean Scar RepairProcedure or surgery
Participants in this arm undergo single-layer closure of the uterine incision during cesarean delivery. The procedure involves a single continuous suture approximating the full thickness of the uterine wall. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the double-layer cesarean scar repair arm.
| Study group | Role | What they receive |
|---|---|---|
| Double-Layer Cesarean Scar Repair | Experimental | Participants in this arm receive double-layer closure of the cesarean section scar according to the study protocol. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the single-layer cesarean scar repair arm. Receives: Procedure: Double-Layer Cesarean Scar Repair |
| Single-Layer Cesarean Scar Repair | Experimental | Participants in this arm receive single-layer closure of the cesarean section scar according to the study protocol. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the double-layer cesarean scar repair arm. Receives: Procedure: Single-Layer Cesarean Scar Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myometrial Thickness at Cesarean Scar Site
Myometrial thickness at the cesarean scar site will be measured using transvaginal ultrasonography (TVUSG) by a qualified obstetrician at 6 months after surgery to compare the effects of single-layer versus double-layer cesarean scar closure.
Measurement Tool / Parameter: TVUSG; residual myometrial thickness (mm). Units of Measure: Millimeters (mm).
Measured: 6 months postoperatively
Secondary outcomes (4)
Cesarean Scar-Related Symptoms
Presence of cesarean scar-related symptoms at 6 months after surgery. Parameters Assessed: Postmenstrual spotting (yes/no), pelvic pain (yes/no), dyspareunia (yes/no) Measurement Tool / Method: Clinical interview during follow-up visit and review of outpatient medical records.
Units of Measure: Incidence (n, %)
Measured: 6 months postoperatively
Cesarean Scar Defect (Isthmocele)
Presence of cesarean scar defect (isthmocele) detected by transvaginal ultrasonography.
Measurement Tool / Method: Transvaginal ultrasonography. Units of Measure: Incidence (number of participants with isthmocele, %)
Measured: 6 months postoperatively
Major Uterine Scar-Related Complications
Occurrence of major uterine scar-related complications within 6 months after surgery.
Parameters Assessed: Uterine rupture, cesarean scar pregnancy, abnormal uterine bleeding Measurement Tool / Method: Clinical examination and medical record review. Units of Measure: Incidence (n, %)
Measured: Up to 6 months postoperatively
Morphological Characteristics of Cesarean Scar Defect
Morphological characteristics of cesarean scar defect measured by transvaginal ultrasonography.
Parameters Assessed: Isthmocele depth (mm), isthmocele width (mm) Measurement Tool / Method: Transvaginal ultrasonography. Units of Measure: Millimeters (mm)
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start11 Nov 2025
- Primary completion21 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
- Investigators
- Merve Didem Eşkin Tanrıverdi, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323355
- Sponsor's protocol ID
- TABED 1-25-1872
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are available which may be shared in necessary conditions.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Single-Layer Versus Double-Layer Cesarean Scar Repair on Myometrial Thickness and Associated Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07323355
- Acronym / sponsor ID
- TABED 1-25-1872
- Conditions
- Caesarean Section, Cesarean Scar Closure, Cesarean Scar Defect (Isthmococele), Myometrial Thickness, Postpartum Complications, Clinical Outcomes
- Keywords
- Caesarean Section, Cesarean Scar Closure, Isthmococele, Myometrial Thickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 7 Jan 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.
Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with a rising incidence particularly in high-income countries. Although often life-saving, cesarean delivery carries both short- and long-term maternal risks. Early complications include infection, hemorrhage, and thromboembolism, while inadequate uterine healing can lead to future complications such as uterine rupture and placenta accreta spectrum disorders. Additionally, cesarean scars may result in pregnancy complications, isthmocele formation, postmenstrual bleeding, pelvic pain, and dysmenorrhea. This highlights the need for optimization of the surgical technique. Despite increasing cesarean rates, there is no consensus on the optimal uterine closure method. Techniques vary in terms of the number of layers, suture locking style, and inclusion of the endometrium, and their comparative effectiveness in reducing scar defects remains unclear. Some previous studies have reported increased uterine rupture risk with single-layer locked sutures and better healing with double-layer closure, while others found no significant difference in scar outcomes. This study aims to investigate the effects of single- versus double-layer cesarean scar closure on myometrial thickness and its clinical implications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-Layer Cesarean Scar Repair | Experimental | Procedure: Double-Layer Cesarean Scar RepairParticipants in this arm receive double-layer closure of the cesarean section scar according to the study protocol. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the single-layer cesarean scar repair arm. |
| Single-Layer Cesarean Scar Repair | Experimental | Procedure: Single-Layer Cesarean Scar RepairParticipants in this arm receive single-layer closure of the cesarean section scar according to the study protocol. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the double-layer cesarean scar repair arm. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female participants aged 18-44 years.
- Undergoing cesarean delivery at the study hospital's Obstetrics and Gynecology clinic.
- Evaluated as clinically eligible based on history, physical examination, abdominal ultrasonography, and routine preoperative laboratory tests, including:
- Complete blood count (CBC), biochemical profile, prothrombin time (PT), activated partial thromboplastin time (aPTT), blood group determination. No abnormalities detected in the above assessments.
Key exclusion criteria (6 listed)
- Presence of chronic diseases, including: Rheumatologic diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, thyroid disease, congenital hematologic disorders.
- Suspected or confirmed placenta previa or placenta accreta spectrum.
- Clinical chorioamnionitis.
- Anterior wall uterine myomas.
- History of low transverse nonstandard uterine incision.
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 |
|---|---|---|
| Double-Layer Cesarean Scar RepairParticipants in this arm undergo double-layer closure of the uterine incision during cesarean delivery. The procedure involves suturing the full thickness of the myometrium in the first layer, followed by a second continuous suture approximating the outer myometrium and serosa. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the single-layer cesarean scar repair arm. | Procedure or surgery | Double-Layer Cesarean Scar Repair |
| Single-Layer Cesarean Scar RepairParticipants in this arm undergo single-layer closure of the uterine incision during cesarean delivery. The procedure involves a single continuous suture approximating the full thickness of the uterine wall. Outcomes such as myometrial thickness, scar integrity, and clinical parameters are measured. This arm is compared in parallel with the double-layer cesarean scar repair arm. | Procedure or surgery | Single-Layer Cesarean Scar Repair |
Primary outcome
Myometrial Thickness at Cesarean Scar Site
Time frame: 6 months postoperatively
Myometrial thickness at the cesarean scar site will be measured using transvaginal ultrasonography (TVUSG) by a qualified obstetrician at 6 months after surgery to compare the effects of single-layer versus double-layer cesarean scar closure. Measurement Tool / Parameter: TVUSG; residual myometrial thickness (mm). Units of Measure: Millimeters (mm).
4 secondary outcomes
Cesarean Scar-Related Symptoms
Time frame: 6 months postoperatively
Cesarean Scar Defect (Isthmocele)
Time frame: 6 months postoperatively
Major Uterine Scar-Related Complications
Time frame: Up to 6 months postoperatively
Morphological Characteristics of Cesarean Scar Defect
Time frame: 6 months postoperatively
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 7 Jan 2026.
- Individual participant dataSharing planned: No. IPD are available which may be shared in necessary conditions.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Merve Didem Eşkin Tanrıverdi principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-Layer Cesarean Scar Repair and Single-Layer Cesarean Scar Repair in people with Caesarean Section and Cesarean Scar Closure, run by Ankara City Hospital Bilkent 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 4 inclusion and 6 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 7 Jan 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 Merve Didem Eşkin Tanrıverdi, MD (+905354071467, mrvddm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myometrial Thickness at Cesarean Scar Site (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.