Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women

Официальное название

The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial

Обзор

This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery. Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.

Подробное описание

Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.

This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.

Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.

Вмешательства

• Процедура Single-Layered Non-Locked Closure with Decidual Inclusion
  During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health.
• Процедура Single-Layered Non-Locked Closure with Decidual Sparing
  Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications.

Первичные конечные точки

• Proportion of participants with a cesarean scar niche measured by ultrasound [Срок оценки: 6 to 9 months post-operation]

Вторичные конечные точки (12)

• Operative time [Срок оценки: Periprocedural]
• Need for additional sutures for hemostasis [Срок оценки: Periprocedural]
• Length of hospital stay [Срок оценки: Postoperative day 2]
• Postoperative pain intensity on the 11-point Numeric Rating Scale [Срок оценки: Postoperative day 2]
• Postoperative bleeding [Срок оценки: Postoperative day 2]
• Wound infection [Срок оценки: Postoperative day 2]
• Postoperative fever [Срок оценки: Postoperative day 2]
• Abnormal uterine bleeding [Срок оценки: 6 to 9 months post-operation]
• Dysmenorrhea [Срок оценки: 6 to 9 months post-operation]
• Chronic pelvic pain [Срок оценки: 6 to 9 months post-operation]
• Dyspareunia [Срок оценки: 6 to 9 months post-operation]
• Cesarean scar niche length measured by ultrasound in mm [Срок оценки: 6 to 9 months post-operation]

Критерии участия

Критерии включения

• Singleton, term pregnancy
• Elective cesarean section before labor onset or membrane rupture
• Maternal age >18 years
• Ability to provide informed consent

Критерии исключения

• Placenta previa
• Maternal substance abuse or infection
• Suspected placenta accreta
• Diabetes
• one or more prior cesarean section
• Vulnerable participants (e.g., mental health conditions)
• Emergency cesarean sections

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• Kantonsspital Baden — Baden

Идентификаторы

NCT: NCT07608874 · StudyKSBHAM001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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