Evaluation of the EPDS and PC-PTSD-5 Scales for Screening Postpartum Mental Health Disorders Among Migrant Women.
NCT07929272, Not applicable, Not yet recruiting, Fondation Hôpital Saint-Joseph
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of the EPDS and PC-PTSD-5 Scales for Screening Postpartum Mental Health Disorders Among Migrant Women. | ClinicalTrials.gov |
| NCT number | NCT07929272 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondation Hôpital Saint-Joseph | ClinicalTrials.gov |
| Conditions | Post Partum Depression | ClinicalTrials.gov |
| Interventions | psychiatric interview | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Comparison of PC-PTSD Score with psychiatric evaluation of PTSD | 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 | ClinicalTrials.gov |
| Primary | Comparison of EPDS Score with psychiatric evalution of post partum depression | 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. | ClinicalTrials.gov |
| Secondary | Description of post partum depression symptoms and PTSD symptoms | 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). | ClinicalTrials.gov |
| Secondary | 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 | 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). | ClinicalTrials.gov |
| Secondary | Proportion of false-positive generated by the EPDS and PC-PTSD-5 screening scales, compared to the psychiatric interview | 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 | ClinicalTrials.gov |
| Secondary | To assess women's perceptions of completing these self-administered questionnaires, particularly regarding the cultural relevance of the items and the mode of administration. | from enrollement to 10 weeks post partum | Qualitative characterization of false-positive cases based on findings from the interviews. | ClinicalTrials.gov |
| Secondary | Identification of potential adaptations of the EPDS and PC-PTSD-5 | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)