Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele (CESARIS)

30 de octubre de 2026 actualizado por: Cristina Mula Navarro, Hospital Clinic of Barcelona

Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele and Its Ultrasound and Molecular Characteristics: a Randomized Controlled Trial

Pregnant women, irrespective of their pregnancy risk, who undergo a cesarean section for any reason will be randomized to one of two suturing techniques: conventional suture or barbed suture for uterine repair after the cesarean section. Following surgery, these patients will be followed up for clinical outcomes, ultrasound evaluation of the uterine scar, and study of the hypoxic-inflammatory environment of the uterine cavity.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

A randomized controlled trial will be conducted among pregnant women, irrespective of their pregnancy risk, undergoing cesarean sections at a tertiary care hospital. Participants will be randomly assigned to one of two groups: the intervention group, which will receive barbed suture for myometrial repair following the cesarean section, or the control group, which will receive conventional smooth suture. This study aims to compare a range of outcomes related to clinical, ultrasonographic, and molecular parameters of the uterine scar and the development of isthmocele.

Main hypothesis: The use of barbed suture for hysterorrhaphy during cesarean section, compared to conventional smooth sutures, results in reduced ischemia and necrosis of the myometrial tissue, facilitating better healing. This is associated with a lower incidence of isthmocele at six months postpartum, and a decrease in its ultrasound dimensions, evaluated by transvaginal ultrasound with hysterosonography.

Secondary hypothesis:

  • The use of barbed suture during cesarean delivery leads to a reduction in molecular biomarker levels of hypoxia and inflammation within the uterine cavity.
  • The employment of barbed suture is associated with a decrease in the frequency of symptoms related to isthmocele in the short term, or a lower intensity of symptoms if they occur, compared to conventional suture.
  • Patients who develop isthmocele after cesarean delivery present predisposing myometrial characteristics and additional risk factors compared to patients with normal healing.
  • The study of myometrial texture patterns based on ultrasound images of the uterine wall in the postpartum period following cesarean delivery may provide predictive data regarding the risk of developing isthmocele at six months postpartum.
  • The stiffness of the uterine scar measured by the strain ratio (SR) is lower among patients included in the barbed suture group than in patients in the conventional suture group.
  • Uterine repair with barbed suture during the cesarean section leads to better perinatal outcomes in the subsequent pregnancies.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

420

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: Cristina Mula
  • Número de teléfono: +34 635486919
  • Correo electrónico: mula@clinic.cat

Ubicaciones de estudio

  • España
      • Barcelona, España
        • Reclutamiento
        • Hospital Clínic de Barcelona
        • Contacto:
          • Cristina Mula
          • Número de teléfono: +34 635486919
          • Correo electrónico: mula@clinic.cat

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Pregnant women who deliver at Hospital Clinic of Barcelona by a planned, intrapartum or urgent cesarean section, irrespective of their pregnancy risk.
  • Had accepted to participate in the study during the third trimester of gestation.
  • Patients who accept a 6-month follow-up visit.
  • Minimal maternal age of 18 years old.

Exclusion Criteria:

  • Patients who end up delivering in another center.
  • Patients who deliver by vaginal route.
  • Patients diagnosed with isthmocele prior to the current pregnancy.
  • Need for histerectomy in the following 6 months after delivery.
  • Patients with known allergies to any of the components of the barbed suture.

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: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Study Group: Uterine repair with barbed suture

Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique.
Dispositivo: Barbed suture

Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
Comparador activo: Control Group: Uterine repair with conventional smooth suture

Uterine repair following cesarean section is performed using a conventional smooth polyglactin suture with a continuous single-layer, endometrium-free technique, in accordance with the standard procedure at our center.
Dispositivo: Conventional smooth suture

Size 1 smooth multifilament absorbable polyglactin suture.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of Isthmocele
Periodo de tiempo: Nine to twelve months after cesarean section.

Rate of isthmocele at nine to twelve months after cesarean section examined by transvaginal ultrasonography with hysterosonography.
Nine to twelve months after cesarean section.
Ultrasonographic Measurements of Isthmocele
Periodo de tiempo: Nine to twelve months after cesarean section.

Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100[%]).
Nine to twelve months after cesarean section.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intrauterine molecular markers of hypoxia and inflammation
Periodo de tiempo: Nine to twelve months after cesarean section.

Concentrations of the following biomarkers will be assessed by analyzing an endocavitary lavage of the uterus: SDF-1/CXCL12 (an indirect marker of tissue hypoxia), G-CSF, IL-1β, IL-6, IL-10 and TNF-α (inflammatory cytokines).
Nine to twelve months after cesarean section.
Symptoms
Periodo de tiempo: Nine to twelve months after cesarean section.

Evaluation of symptoms related to CSD six months after cesarean section, measured as the presence of one or more of the following: prolonged postpartum bleeding, spotting, abnormal menstrual bleeding, dysmenorrhea, pelvic pain and/or dyspareunia.
Nine to twelve months after cesarean section.
Risk factors
Periodo de tiempo: Through study completion, an average of 2 years.

Collection of individual data in relation to the patient characteristics and the surgical procedure to evaluate potential risk factors.

Individual data: Age at inclusion, ethnicity, educational level, parity, number of cesarean deliveries, history of uterine surgery or other abdominal surgeries, body mass index, smoking status, gestational or pregestational diabetes, hypertension, other medical conditions.

Surgical data: Location of the hysterotomy, need for additional hemostatic sutures, need for hemostatic material at the surgical site, requirement for antifibrinolytic or uterotonic treatment to control bleeding, estimated blood loss during the surgery.
Through study completion, an average of 2 years.
Ultrasonographic myometrial texture patterns
Periodo de tiempo: Nine to twelve months after cesarean section.
Nine to twelve months after cesarean section.
Stiffness of the uterine scar
Periodo de tiempo: Nine to twelve months after cesarean section.

Stiffness differences of the uterine scar between the two groups will be compared by measuring the strain ratio (SR).
Nine to twelve months after cesarean section.
Perinatal outcomes in following pregnancies
Periodo de tiempo: Through study completion, an average of 4 years.

Perinatal outcomes in subsequent pregnancies will be measured as the presence of one of the following: miscarriage, ectopic pregnancy, uterine rupture, placental accretism, cesarean delivery among others.
Through study completion, an average of 4 years.

Colaboradores e Investigadores

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

Patrocinador

Hospital Clinic of Barcelona

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)

22 de noviembre de 2024

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de noviembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

14 de noviembre de 2024

Publicado por primera vez (Actual)

15 de noviembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

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

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HCB/2024/0196

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

producto fabricado y exportado desde los 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. .

Suscribir