Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness

Ankara City Hospital

Status: Enrolling

Conditions: Caesarean Section; Cesarean Scar Defect (Isthmococele); Postpartum Complications; Clinical Outcomes; Myometrial Thickness; Cesarean Scar Closure

Treatments: Procedure: Single-Layer Cesarean Scar Repair; Procedure: Double-Layer Cesarean Scar Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT07323355

TABED 1-25-1872

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

- 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups

Double-Layer Cesarean Scar Repair

Experimental group

Description:

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.

Treatment:

Procedure: Double-Layer Cesarean Scar Repair

Single-Layer Cesarean Scar Repair

Experimental group

Description:

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.

Treatment:

Procedure: Single-Layer Cesarean Scar Repair