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Recruiting Not applicable

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

NCT07323355 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-11
Last updated
2026-01-07

Condition(s) studied

Caesarean SectionCesarean Scar ClosureCesarean Scar Defect (Isthmococele)Myometrial ThicknessPostpartum ComplicationsClinical Outcomes

Investigational drug(s) / intervention(s)

Double-Layer Cesarean Scar RepairSingle-Layer Cesarean Scar Repair

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
44 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Myometrial Thickness at Cesarean Scar Site — 6 months postoperatively
    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).

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara Not Valid Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07323355 on ClinicalTrials.gov ↗ ← All trials in Turkey