Aún no reclutaNCT07929272Registro de ClinicalTrials.gov

Evaluation of the EPDS and PC-PTSD-5 Scales for Screening Postpartum Mental Health Disorders Among Migrant Women.

Post Partum Depression

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - No especificado
Sexo admitido: Femenino
Voluntarios sanos: No aceptados
Participantes: 80 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Postpartum depression (affecting approximately 15% of women) and childbirth-related post-traumatic stress disorder (PTSD) (affecting approximately 5%) are major public health concerns due to their frequency and their impact on both maternal and child health. Diagnosis relies on specialized clinical interviews, which are difficult to offer systematically to all women after childbirth. Consequently, self-report screening tools are widely used, particularly the Edinburgh Postnatal Depression Scale (EPDS) for postpartum depression and the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) for PTSD.

However, these tools were developed and validated in the general population and may be less suitable for certain groups, particularly migrant women, who are at increased risk of postpartum mental health disorders. Their migration experiences are sometimes marked by traumatic events, which may contribute to complex forms of PTSD, and their clinical presentations may differ from those typically observed. Certain culturally specific expressions of psychological distress, dissociative symptoms, or somatic manifestations are not captured by current screening questionnaires.

Furthermore, cultural differences, perceptions of mental health, and language barriers may complicate the psychological assessment of these women and influence their responses to screening tools. These specific factors suggest that existing questionnaires may have insufficient diagnostic performance in some groups of migrant women.

The Psy4Mums project therefore aims to assess the relevance and performance of these screening tools in migrant populations that are particularly vulnerable from psychological, social, and economic perspectives. This evaluation may, if necessary, lead to adaptations in their content, cutoff scores, or methods of administration in order to improve the identification of postpartum mental health disorders. This approach is especially important in French Guiana, where more than half of all women giving birth are migrants.

¿Quién podría participar?

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Inclusion Criteria:

Adult woman (≥18 years old) Having delivered in one of the three participating centers during the inclusion period Migrant woman: born abroad, holding a foreign nationality, and delivering in France for the Paris Saint-Joseph and Montreuil sites Migrant woman (born abroad with a foreign nationality) or native woman (born in French Guiana) for the Cayenne site Covered or not covered by a health insurance scheme (see rationale in Appendix 3) French-speaking or non-French-speaking (non-French-speaking women may be included with the assistance of a professional interpreter or intercultural mediator) Having provided free, informed, and explicit oral consent to participate in the study

Exclusion Criteria:

dentified personal psychiatric history (major depressive disorder, bipolar disorder, psychotic disorder, or diagnosed PTSD), documented in the medical record or self-reported during the inclusion interview; current psychotropic medication use; or a psychiatric disorder diagnosed during the postpartum maternity stay prior to discharge Participation in another interventional research study classified as RIPH1 Individuals subject to a legal protection measure (safeguard of justice, guardianship, or curatorship) Individuals deprived of their liberty

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

psychatric interview

No informado en este registro.

Other: psychiatric interview

psychiatric interview OTHER

At 6 to 10 weeks postpartum, the patient attends an interview with a psychiatrist specialized in perinatal psychiatry. During this consultation, the patient completes the Edinburgh Postnatal Depression Scale (EPDS) and the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) questionnaires. The physician then assesses the patient's level of difficulty in completing these questionnaires. This is followed by a standard 45-minute psychiatric clinical assessment focusing on the patient's experience of pregnancy.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Comparison of PC-PTSD Score with psychiatric evaluation of PTSD

Plazo: from enrollement to 10 week post partum

Proportion of women with PTSD identified during the psychiatric interview (gold standard) but with a PC-PTSD-5 score \< 4, below the conventionally used screening cutoff (false-negative result of the scale), estimated separately in each of the two groups

Comparison of EPDS Score with psychiatric evalution of post partum depression

Plazo: from enrollement to 10 week post partum

Proportion of women with postpartum depression identified during the psychiatric interview (gold standard) but with an EPDS score \< 11, i.e., below the screening cutoff conventionally used in current clinical practice (false-negative result of the scale), estimated separately among migrant women in the Paris region (Île-de-France) and French Guiana, and among women native to French Guiana.