Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women (DISSUC)
The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
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.
Обзор исследования
Статус
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Amr S. Hamza, Assoc. Prof.
- Номер телефона: +41564863513
- Электронная почта: amr.hamza@ksb.ch
Учебное резервное копирование контактов
- Имя: Leonhard Schaeffer, Prof.
- Номер телефона: +41564863506
- Электронная почта: leonhard.schaeffer@ksb.ch
Места учебы
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Canton of Aargau
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Baden, Canton of Aargau, Швейцария, 5400
- Рекрутинг
- Kantonsspital Baden
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Контакт:
- Amr S. Hamza, Assoc. Prof.
- Номер телефона: +41564863513
- Электронная почта: amr.hamza@ksb.ch
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Контакт:
- Leonhard Schaeffer, Prof.
- Номер телефона: +41564863506
- Электронная почта: leonhard.schaeffer@ksb.ch
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Singleton, term pregnancy
- Elective cesarean section before labor onset or membrane rupture
- Maternal age >18 years
- Ability to provide informed consent
Exclusion Criteria:
- 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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Decidual Inclusion Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture.
All other operative steps will be performed according to the standardized study protocol.
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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. |
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Экспериментальный: Decidual Sparing Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture.
All other operative steps will be performed according to the standardized study protocol.
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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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Proportion of participants with a cesarean scar niche measured by ultrasound
Временное ограничение: 6 to 9 months post-operation
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Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound.
The outcome will be reported as the proportion of participants with a niche in each treatment group.
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6 to 9 months post-operation
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Residual-to-adjacent myometrial thickness ratio
Временное ограничение: 6 to 9 months post-operation
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Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
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6 to 9 months post-operation
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Operative time
Временное ограничение: Periprocedural
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Operative time in minutes
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Periprocedural
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Need for additional sutures for hemostasis
Временное ограничение: Periprocedural
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Need for additional hemostatic sutures, yes (how many: __ Number) /no
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Periprocedural
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Length of hospital stay
Временное ограничение: Postoperative day 2
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Length of postoperative hospital stay in days
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Postoperative day 2
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Postoperative pain intensity on the 11-point Numeric Rating Scale
Временное ограничение: Postoperative day 2
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Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Postoperative day 2
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Postoperative bleeding
Временное ограничение: Postoperative day 2
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Clinically relevant postoperative bleeding, yes/no
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Postoperative day 2
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Wound infection
Временное ограничение: Postoperative day 2
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Postoperative wound infection, yes/no
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Postoperative day 2
|
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Postoperative fever
Временное ограничение: Postoperative day 2
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Postoperative fever, yes/no
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Postoperative day 2
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Abnormal uterine bleeding
Временное ограничение: 6 to 9 months post-operation
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Abnormal uterine bleeding reported at follow-up, yes/no
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6 to 9 months post-operation
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Dysmenorrhea
Временное ограничение: 6 to 9 months post-operation
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Dysmenorrhea reported at follow-up, yes/no
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6 to 9 months post-operation
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Chronic pelvic pain
Временное ограничение: 6 to 9 months post-operation
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Chronic pelvic pain reported at follow-up, yes/no
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6 to 9 months post-operation
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Dyspareunia
Временное ограничение: 6 to 9 months post-operation
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Dyspareunia reported at follow-up, yes/no
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6 to 9 months post-operation
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Cesarean scar niche length measured by ultrasound in mm
Временное ограничение: 6 to 9 months post-operation
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Length of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Cesarean scar niche depth measured by ultrasound in mm
Временное ограничение: 6 to 9 months post-operation
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Depth of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Cesarean scar niche width measured by ultrasound in mm
Временное ограничение: 6 to 9 months post-operation
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Width of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
Временное ограничение: 6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
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6 to 9 months post-operation
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Presence of intrauterine fluid on ultrasound
Временное ограничение: 6 to 9 months post-operation
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Presence or absence of intrauterine fluid on ultrasound.
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6 to 9 months post-operation
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Amr S. Hamza, Assoc. Prof., Kantonsspital Baden
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Генитальные заболевания
- Психические расстройства
- Заболевания половых органов, мужчины
- Мужские мочеполовые заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Заболевания половых органов, Женский
- Сексуальная дисфункция, физиологическая
- Сексуальные дисфункции, психологические
- Диспареуния
Другие идентификационные номера исследования
- StudyKSBHAM001
Планирование данных отдельных участников (IPD)
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Изучает лекарственный продукт, регулируемый FDA США.
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