- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07827508
Assessment of Childbirth-Related Post-Traumatic Stress Disorder (SSPT-A)
Assessment of Childbirth-Related Post-Traumatic Stress Disorder: A Single-Center Prospective Study
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Edgar Yohny Montoya Ramirez, MD
- Telefonnummer: +33 3 89 64 64 64
- E-post: montoyaramireze@ghrmsa.fr
Studieorter
-
-
-
Mulhouse, Frankrike, 68100
- Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
City Birth Trauma Scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Questionnaire on the assessment of healthcare utilization
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GHRMSA 1497
- ID-RCB 2026-A00733-48 (Annan identifierare: Agence nationale de sécurité du médicament et des produits de santé)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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