Uso versus no uso del cateterismo vesical en el parto por cesárea electiva
Un ensayo controlado aleatorio del uso versus la no utilización del cateterismo vesical en el parto por cesárea electiva
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
-
Calgary, Alberta, Canadá, T2N 2T9
- University of Calgary
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.
Exclusion criteria:
- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Bladder catheterization
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section. |
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section. |
|
Sin intervención: Non-use of bladder catheterization
Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to ambulation
Periodo de tiempo: Prior to discharge, assessed up to 3 days postpartum
|
Time to ambulation will be collected via a form that will be distributed by the postpartum nursing team. |
Prior to discharge, assessed up to 3 days postpartum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of urinary retention
Periodo de tiempo: Prior to discharge, assessed up to 3 days postpartum
|
Urinary retention will be defined based on a patient's inability to spontaneously void requiring either in-and-out catheterization or placement of an indwelling catheter during the post operative course |
Prior to discharge, assessed up to 3 days postpartum
|
|
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
Periodo de tiempo: first 4 weeks postpartum
|
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum |
first 4 weeks postpartum
|
|
Incidence of bladder injury in surgery
Periodo de tiempo: During surgery
|
Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
During surgery
|
|
Operating time
Periodo de tiempo: During surgery
|
Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
During surgery
|
|
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
Periodo de tiempo: At discharge, assessed up to 3 days postpartum
|
Patients will be asked to complete the Maternal Satisfaction for Cesarean Section questionnaire at discharge. The minimum and maximum values are 7 and 154 and higher scores mean a better outcome. |
At discharge, assessed up to 3 days postpartum
|
|
Time to discharge
Periodo de tiempo: At discharge, assessed up to 3 days postpartum
|
Time to discharge; date and time of discharge will be collected during chart review |
At discharge, assessed up to 3 days postpartum
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephen L. Wood, MD, MSc, University of Calgary
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REB24-0044
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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