Oral Feeding During Established Labor at Our Institution
12 de abril de 2018 actualizado por: Hospices Civils de Lyon
Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)
Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia.
To date, no study assessed how these guidelines are followed in clinical practice.
This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
195
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.
Ubicaciones de estudio
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Bron, Francia, 69677
- Hopital Femme Mere Enfant
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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
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
All adult women who were in labor in our hospital interviewed within 2 hours after vaginal delivery or cesarean section decided during the labor
Descripción
Inclusion Criteria:
- All adult woman who has been in labor in our hospital
Exclusion Criteria:
- Patient refusal
- Elective cesarean section, or emergency cesarean section in a woman not in labor
- Intrauterine fetal death
- Therapeutic abortion
- Patient consent not available (for example, in case of severe post-partum hemorrhage)
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Rate of parturients who declared to have ingested clear fluid during the labor.
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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The survey will be completed within 2 hours following the delivery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Determine the instructions given by health professionals, their spontaneous or non-spontaneous character and the information related to the given fast, according to the parturient
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Determine the instructions given by health professionals, whether they are spontaneous or not
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The survey will be completed within 2 hours following the delivery
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Specify the type of liquid ingested (water or sweet liquid) and its volume
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Nature and volume of liquids ingested
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The survey will be completed within 2 hours following the delivery
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Specify the frequency of ingestion of solid foods during labor
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Nature and quantity of ingested solids
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The survey will be completed within 2 hours following the delivery
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Assess the degree of discomfort associated with thirst that was felt during labor
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Degree of discomfort related to thirst on a simple numeric scale (0: no discomfort at 10: very uncomfortable)
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The survey will be completed within 2 hours following the delivery
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Assess the degree of discomfort associated with hunger that was felt during labor
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Degree of discomfort related to hunger on a simple numeric scale (0: no discomfort at 10: very uncomfortable)
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The survey will be completed within 2 hours following the delivery
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Evaluate women's satisfaction with the fasting instructions received
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Satisfaction with fasting instructions given on a simple numerical scale (0: very high dissatisfaction, 10: maximum satisfaction)
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The survey will be completed within 2 hours following the delivery
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Determine if nausea and vomiting are more common in women who have ingested fluids during labor
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Incidence of at least one episode of nausea and vomiting during labor
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The survey will be completed within 2 hours following the delivery
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Analyze the factors associated with fasting during work and their concordance with the French recommendations on fasting during labor
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Analysis of independent risk factors for the patient's strict fasting during labor
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The survey will be completed within 2 hours following the delivery
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Indicate the total duration of fast and solid fasting before birth
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Total duration of liquid fasting and solids preceding birth
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The survey will be completed within 2 hours following the delivery
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Compare fasting instructions received by patients and practices reported by professionals
Periodo de tiempo: The survey will be completed within 2 hours following the delivery
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Fasting instructions received by patients and practices reported by professionals obtained during a practice survey
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The survey will be completed within 2 hours following the delivery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
25 de agosto de 2017
Finalización primaria (Actual)
25 de noviembre de 2017
Finalización del estudio (Actual)
25 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2017
Publicado por primera vez (Actual)
8 de agosto de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de abril de 2018
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 69HCL17_0454
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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