Assessment of Childbirth-Related Post-Traumatic Stress Disorder (SSPT-A)
Assessment of Childbirth-Related Post-Traumatic Stress Disorder: A Single-Center Prospective Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Secondary objectives
To identify risk factors associated with the development of PTSD, in order to determine which situations-particularly obstetric ones-could lead women to experience trauma, and understand the underlying psychological mechanisms.
Risk factors identified in the literature or deemed relevant by the study's clinicians and psychologists will be gathered from medical records.
- To assess healthcare utilization in the context of the onset of childbirth-related PTSD from the women's perspective, using a questionnaire consisting of a series of questions about the different healthcare professionals consulted during the month following childbirth.
Conduct of research About one month after giving birth, women who have provided their consent will receive an email containing a personal link to the eCRF page where they will find the French version of the "City Birth Trauma Scale" (CBTS) questionnaire, as well as the questionnaire designed to assess their use of healthcare services.
After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD.
If the participant has not completed the questionnaire within 10 days of receiving the link, a follow-up email will be sent to her. If, after receiving this follow-up email, the participant has not completed the questionnaire or contacted the research team, she will be considered lost to follow-up.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Edgar Yohny Montoya Ramirez, MD
- Número de teléfono: +33 3 89 64 64 64
- Correo electrónico: montoyaramireze@ghrmsa.fr
Ubicaciones de estudio
-
-
-
Mulhouse, Francia, 68100
- Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Women aged 18 or older
- Having given birth in the maternity ward at Emile Muller Hospital (Mulhouse, Haut-Rhin, France)
- Fluent in French
- Having provided written consent to participate in the study
- Being covered by a social security program
Exclusion Criteria:
- Women who gave birth anonymously
- Women who gave birth to a stillborn child or a fetus that died in utero
- Women under legal protection (guardianship, conservatorship, judicial protection).
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: Women who have given birth within the past month
|
About one month after giving birth, patients who have given their consent will receive an email containing a personal link to the eCRF page with the French version of the City Birth Trauma Scale (CBTS) questionnaire, as well as a questionnaire to assess their use of healthcare services. After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
City Birth Trauma Scale
Periodo de tiempo: About 1 month after childbirth
|
The diagnosis of PTSD based on responses to the questionnaire will be made in accordance with the questionnaire's scoring method, which assesses 8 criteria based on the DSM-5 (criteria labeled A through H).
|
About 1 month after childbirth
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Questionnaire on the assessment of healthcare utilization
Periodo de tiempo: About 1 month after childbirth
|
A ten-item questionnaire to assess the use of healthcare services in the context of postpartum post-traumatic stress disorder from the women's perspective, enquiring about the healthcare professionals these women consulted during the month following childbirth.
|
About 1 month after childbirth
|
Colaboradores e Investigadores
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GHRMSA 1497
- ID-RCB 2026-A00733-48 (Otro identificador: Agence nationale de sécurité du médicament et des produits de santé)
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. .