Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07929272
Not yet recruitingNCT07929272ClinicalTrials.gov record

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

Post Partum Depression

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
Female
Healthy volunteers
Not accepted
Participants
80 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
psychatric interview

Not reported in this registry record.

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Comparison of PC-PTSD Score with psychiatric evaluation of PTSD

Time frame: 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

Time frame: 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.

Secondary measures

Description of post partum depression symptoms and PTSD symptoms

Time frame: from enrollement to 10 weeks post partum

Nature and significance of the symptoms identified during the psychiatric interview that are not covered by the items included in the two screening scales (qualitative component of the primary outcome).

Evaluation ofthe performance of the EPDS and PC-PTSD-5 as screening tools for postpartum depression (PPD) and post-traumatic stress disorder (PTSD) among groups of migrant women in the Paris region (Île-de-France) and French Guiana, as well as a group of

Time frame: from enrollement to 10 weeks post partum

Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for different EPDS (PPD) and PC-PTSD-5 (PTSD) cutoff scores, estimated separately in each group (migrant women; native women from French Guiana), and subsequently according to the level of obstetric risk (exploratory analyses).

Proportion of false-positive generated by the EPDS and PC-PTSD-5 screening scales, compared to the psychiatric interview

Time frame: from enrollement to 10 weeks post partum

Proportion of false-positive results on the EPDS (score ≥ 11 without confirmed PPD) and the PC-PTSD-5 (score ≥ 4 without confirmed PTSD) based on the psychiatric interview among migrant women in the Paris region and French Guiana, and among a group of non-migrant women in French Guiana

To assess women's perceptions of completing these self-administered questionnaires, particularly regarding the cultural relevance of the items and the mode of administration.

Time frame: from enrollement to 10 weeks post partum

Qualitative characterization of false-positive cases based on findings from the interviews.

Identification of potential adaptations of the EPDS and PC-PTSD-5

Time frame: from enrollement to 10 weeks post partum

Women's perceptions of completing the questionnaires and their suggestions for adaptation (qualitative analysis), including modifications of cutoff scores, the addition of questions, and adaptations to the content

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

Ch MontreuilMontreuil, FranceStatus unknown
Hôpital Paris Saint JosephParis, FranceStatus unknown
CHU CayenneCayenne, French GuianaStatus unknown

Study team and timeline

Lead sponsor
Fondation Hôpital Saint-Joseph
Study start
2026-12 Estimated
Primary completion
2027-09 Estimated
Study completion
2027-12 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

juliette COURTIADE MAHLERCONTACTjcourtiade@ghpsj.fr+3314412793
Official study title

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026