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Идёт набор NCT07323355

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

Без фазы С лечением Caesarean Section Cesarean Scar Closure Cesarean Scar Defect (Isthmococele) Myometrial Thickness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Double-Layer Cesarean Scar Repair, Single-Layer Cesarean Scar Repair.
Кому может быть актуально
Состояния в реестре: Caesarean Section, Cesarean Scar Closure, Cesarean Scar Defect (Isthmococele), Myometrial Thickness. Базовые параметры: 18 лет — 44 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Процедура 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.
  • Процедура 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.

Первичные конечные точки

  • Myometrial Thickness at Cesarean Scar Site [Срок оценки: 6 months postoperatively]
Вторичные конечные точки (4)
  • Cesarean Scar-Related Symptoms [Срок оценки: 6 months postoperatively]
  • Cesarean Scar Defect (Isthmocele) [Срок оценки: 6 months postoperatively]
  • Major Uterine Scar-Related Complications [Срок оценки: Up to 6 months postoperatively]
  • Morphological Characteristics of Cesarean Scar Defect [Срок оценки: 6 months postoperatively]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT07323355 · TABED 1-25-1872

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗