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

23 de agosto de 2026 actualizado por: Amr Sherif Hamza, Kantonsspital Baden

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

374

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Amr S. Hamza, Assoc. Prof.
  • Número de teléfono: +41564863513
  • Correo electrónico: amr.hamza@ksb.ch

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Suiza
    • Canton of Aargau
      • Baden, Canton of Aargau, Suiza, 5400
        • Reclutamiento
        • Kantonsspital Baden
        • Contacto:
          • Amr S. Hamza, Assoc. Prof.
          • Número de teléfono: +41564863513
          • Correo electrónico: amr.hamza@ksb.ch
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Procedimiento: 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.
Experimental: 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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of participants with a cesarean scar niche measured by ultrasound
Periodo de tiempo: 6 to 9 months post-operation
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.
6 to 9 months post-operation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Residual-to-adjacent myometrial thickness ratio
Periodo de tiempo: 6 to 9 months post-operation
Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
6 to 9 months post-operation
Operative time
Periodo de tiempo: Periprocedural
Operative time in minutes
Periprocedural
Need for additional sutures for hemostasis
Periodo de tiempo: Periprocedural
Need for additional hemostatic sutures, yes (how many: __ Number) /no
Periprocedural
Length of hospital stay
Periodo de tiempo: Postoperative day 2
Length of postoperative hospital stay in days
Postoperative day 2
Postoperative pain intensity on the 11-point Numeric Rating Scale
Periodo de tiempo: Postoperative day 2
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.
Postoperative day 2
Postoperative bleeding
Periodo de tiempo: Postoperative day 2
Clinically relevant postoperative bleeding, yes/no
Postoperative day 2
Wound infection
Periodo de tiempo: Postoperative day 2
Postoperative wound infection, yes/no
Postoperative day 2
Postoperative fever
Periodo de tiempo: Postoperative day 2
Postoperative fever, yes/no
Postoperative day 2
Abnormal uterine bleeding
Periodo de tiempo: 6 to 9 months post-operation
Abnormal uterine bleeding reported at follow-up, yes/no
6 to 9 months post-operation
Dysmenorrhea
Periodo de tiempo: 6 to 9 months post-operation
Dysmenorrhea reported at follow-up, yes/no
6 to 9 months post-operation
Chronic pelvic pain
Periodo de tiempo: 6 to 9 months post-operation
Chronic pelvic pain reported at follow-up, yes/no
6 to 9 months post-operation
Dyspareunia
Periodo de tiempo: 6 to 9 months post-operation
Dyspareunia reported at follow-up, yes/no
6 to 9 months post-operation
Cesarean scar niche length measured by ultrasound in mm
Periodo de tiempo: 6 to 9 months post-operation
Length of cesarean scar niche in mm measured by ultrasound.
6 to 9 months post-operation
Cesarean scar niche depth measured by ultrasound in mm
Periodo de tiempo: 6 to 9 months post-operation
Depth of cesarean scar niche in mm measured by ultrasound.
6 to 9 months post-operation
Cesarean scar niche width measured by ultrasound in mm
Periodo de tiempo: 6 to 9 months post-operation
Width of cesarean scar niche in mm measured by ultrasound.
6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
Periodo de tiempo: 6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
6 to 9 months post-operation
Presence of intrauterine fluid on ultrasound
Periodo de tiempo: 6 to 9 months post-operation
Presence or absence of intrauterine fluid on ultrasound.
6 to 9 months post-operation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Kantonsspital Baden

Investigadores

  • Investigador principal: Amr S. Hamza, Assoc. Prof., Kantonsspital Baden

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de junio de 2026

Finalización primaria (Estimado)

1 de mayo de 2029

Finalización del estudio (Estimado)

30 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

27 de agosto de 2025

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2026

Publicado por primera vez (Actual)

27 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • StudyKSBHAM001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

De-identified individual participant data will not be shared outside the research team because no external data-sharing process has been approved by the ethics committee or institution. Aggregate study results may be shared through publication or presentation.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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