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

NCT ID: NCT07323355

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-11
• Study Completion Date: 2026-11-15

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Double-Layer Cesarean Scar Repair

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.

Group Type: EXPERIMENTAL

Double-Layer Cesarean Scar Repair

Intervention Type: 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.

Single-Layer Cesarean Scar Repair

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.

Group Type: EXPERIMENTAL

Single-Layer Cesarean Scar Repair

Intervention Type: 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.

Interventions

Double-Layer Cesarean Scar Repair

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.

Intervention Type: PROCEDURE

Single-Layer Cesarean Scar Repair

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Merve Didem Eşkin Tanrıverdi

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merve Didem Eşkin Tanrıverdi

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, Not Valid, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Merve Didem Eşkin Tanrıverdi, MD

Role: CONTACT

mrvddm@hotmail.com

+905354071467

Facility Contacts

Merve Didem Eşkin Tanrıverdi, MD

Role: primary

mrvddm@hotmail.com

+903125526000

Other Identifiers

TABED 1-25-1872

Identifier Type: -

Identifier Source: org_study_id