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Recruiting NCT07323355

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

No phase Interventional Caesarean Section Cesarean Scar Closure Cesarean Scar Defect (Isthmococele) Myometrial Thickness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Double-Layer Cesarean Scar Repair, Single-Layer Cesarean Scar Repair.
Who it may be relevant to
Registry conditions: Caesarean Section, Cesarean Scar Closure, Cesarean Scar Defect (Isthmococele), Myometrial Thickness. Basic parameters: 18 years — 44 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Single-Layer Versus Double-Layer Cesarean Scar Repair on Myometrial Thickness and Associated Clinical Outcomes

Overview

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.

Interventions

  • Procedure 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.
  • 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.

Primary outcome measures

  • Myometrial Thickness at Cesarean Scar Site [Time frame: 6 months postoperatively]
Secondary outcome measures (4)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT07323355 · TABED 1-25-1872

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗