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临床试验/NCT07323355
NCT07323355招募中不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年11月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
Myometrial Thickness at Cesarean Scar Site

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • - 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.

研究组 & 干预措施

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.

干预措施: Double-Layer Cesarean Scar Repair (Procedure)

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.

干预措施: Single-Layer Cesarean Scar Repair (Procedure)

结局指标

主要结局

Myometrial Thickness at Cesarean Scar Site

时间窗: 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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Didem Eşkin Tanrıverdi

Medical Doctor

Ankara City Hospital Bilkent

研究点 (1)

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