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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double-Layer Cesarean Scar Repair | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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, %) | 6 months postoperatively |
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Inclusion Criteria:
Complete blood count (CBC), biochemical profile, prothrombin time (PT), activated partial thromboplastin time (aPTT), blood group determination. No abnormalities detected in the above assessments.
Exclusion Criteria:
- Presence of chronic diseases, including: Rheumatologic diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, thyroid disease, congenital hematologic disorders.
This study includes female participants only, as it investigates the effects of single-layer versus double-layer cesarean scar repair on uterine myometrial thickness and related clinical outcomes. Only women who are undergoing cesarean delivery and meet the inclusion criteria are eligible for participation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merve Didem Eşkin Tanrıverdi, MD | Contact | +905354071467 | mrvddm@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Merve Didem Eşkin Tanrıverdi | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Recruiting | Ankara | Not Valid | 06100 | Turkey (Türkiye) |
IPD are available which may be shared in necessary conditions.
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| Single-Layer Cesarean Scar Repair | Procedure | 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. |
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| 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, %) | 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, %) | 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) | 6 months postoperatively |