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

NCT07323355 | Recruiting

• 1 other identifier: TABED 1-25-1872
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

Caesarean Section; Cesarean Scar Closure; Isthmococele; Myometrial Thickness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Cesarean Scar-Related Symptoms

  6 months postoperatively

• Cesarean Scar Defect (Isthmocele)

  6 months postoperatively

• Major Uterine Scar-Related Complications

  Up to 6 months postoperatively

• Morphological Characteristics of Cesarean Scar Defect

  6 months postoperatively

Study Arms (2)

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.

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.

Procedure: Single-Layer Cesarean Scar Repair

Interventions

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.

Double-Layer Cesarean Scar Repair

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.

Single-Layer Cesarean Scar Repair

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Not Valid, 06100, Turkey (Türkiye)

RECRUITING

Study Officials

• Merve Didem Eşkin Tanrıverdi

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Didem Eşkin Tanrıverdi, MD

CONTACT

+905354071467; mrvddm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 7, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)