- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07653646
Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the Auvergne Rhone-Alpes Region (AuRA) (VISIMAT)
Restrictions on Maternity Ward Visits: Current Situation, Challenges and Recommendations in the AuRA Region
Maternal mental health in the postpartum period is a major public health issue in France. The 2021 National Perinatal Survey highlights high prevalence rates of mental health disorders among mothers, with 27.6% experiencing anxiety disorders, 16.7% experiencing depressive disorders and 5.4% having suicidal thoughts. Between 2016 and 2018, suicide was also the leading cause of maternal mortality in the year following childbirth, underscoring the severity and frequency of these disorders. In response, international guidelines, notably those of the World health Organisation (WHO), as well as national policies such as the 'First 1,000 Days' strategy, emphasise the importance of early, enhanced and individualised postnatal support. In France, this postpartum care tends to be structured around the Early Postnatal Interview and the recommended use of validated screening tools such as the Edinburgh Postnatal Depression Scale (EPDS).
However, the quality of postpartum care depends not only on screening and clinical follow-up, but also on organisational and environmental factors. Among these, the arrangements for maternity ward visits constitute a potential determinant of patients' experiences, likely to influence both their mental state, their rest, the establishment of breastfeeding and, indirectly, the health of the newborn. The exceptional measures implemented during the Covid-19 pandemic, notably the restriction of visits, have shown generally favourable effects, with improved satisfaction among patients and healthcare staff, better conditions for rest, facilitation of breastfeeding and a perceived improvement in working conditions.
However, these data were collected in an exceptional health context, which may introduce biases linked to the social, emotional and organisational constraints specific to this period. Their extrapolation to routine practice therefore remains uncertain. Furthermore, in the absence of specific national guidelines governing maternity ward visits, the current regulatory framework remains unclear and practices vary between institutions, often relying on local decisions that have not been scientifically evaluated.
Against this backdrop, the VISIMAT study aims to characterise maternity ward visiting arrangements outside of any exceptional circumstances and to assess their impact on the health of mothers and newborns, as well as on healthcare workers' working conditions. Its aim is to provide a scientific basis to inform the development of standardised recommendations and prevention messages.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marion Beucher, PhD
- Número de teléfono: +33 +33450637032
- Correo electrónico: mbeucher@ch-annecygenevois.fr
Ubicaciones de estudio
-
-
Auvergne-Rhône-Alpes
-
Épagny, Auvergne-Rhône-Alpes, Francia, 74370
- CH Annecy Genevois
-
Contacto:
- Marion Beucher, PhD
- Número de teléfono: +33 +33450637032
- Correo electrónico: mbeucher@ch-annecygenevois.fr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult female patient (aged 18 or over),
- Female patient admitted to the maternity ward with her newborn baby or babies,
- Length of stay in the maternity ward of 48 hours or more,
- Female patient who has been informed about the study and has given her free, informed verbal consent to participate in the study.
Exclusion Criteria:
- Patients who have already participated in this study,
- Patients whose newborn(s) are hospitalised in neonatal units, neonatal intensive care units or neonatal resuscitation units,
- Patients who have given birth to three or more newborns (triplets or more),
- Patient whose newborn(s) has/have died,
- Patient unable to understand spoken or written French, making self-assessment impossible,
- Patient under guardianship, curatorship or placed under judicial protection,
- Patient not covered by the French social security system.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Intervention (additionnal psychological assessment)
The only intervention prompted by the research involves referring patients with an EPDS score of ≥10 and/or a positive response to item 10 of the scale ('has already thought about harming themselves') to a psychologist.
|
The only intervention resulting from the research consists of referring patients with an EPDS score ≥ 10 and/or a positive response to item 10 of this scale ('has already thought about harming themselves') to a psychologist.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effect of visitor restriction levels implemented in maternity wards on mothers' postnatal depressive symptoms
Periodo de tiempo: At discharge from hospitalization in the maternity ward, on average 48 hours
|
The incidence of depressive symptoms in the mother using the Edinburgh Postnatal Depression Scale (EPDS)
|
At discharge from hospitalization in the maternity ward, on average 48 hours
|
|
Effect of visitor restriction levels implemented in maternity wards on early indicators of newborn health.
Periodo de tiempo: Until discharge from hospitalization in the maternity ward, on average 48 hours.
|
Neonatal weight change between birth and discharge from the maternity ward, reflecting the newborn's early health status.
|
Until discharge from hospitalization in the maternity ward, on average 48 hours.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Noëllie FANTINATO, Midwife, Centre Hospitalier Annecy Genevois
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- 24-08
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.
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. .