Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery (PREDICT)
15 de mayo de 2026 actualizado por: Katherine Seligman, University of British Columbia
The goal of this observational study is to learn whether early postpartum screening tools can predict the development of childbirth-related post-traumatic stress symptoms in individuals who undergo unplanned cesarean delivery.
The main questions it aims to answer are:
- Do scores on the Peritraumatic Distress Inventory (PDI) collected 24-48 hours after delivery predict childbirth-related PTSD symptoms at 6 weeks postpartum?
- Do scores on the City Birth Trauma Scale - Short Form (CityBiTS-SF) collected 24-48 hours after delivery predict childbirth-related PTSD symptoms at 6 weeks postpartum?
Participants will:
- Complete questionnaires within 24-48 hours after delivery, including the PDI, CityBiTS-SF, and Edinburgh Postnatal Depression Scale (EPDS).
- Complete follow-up questionnaires at 6 weeks and 3 months postpartum, including measures of PTSD symptoms (PTSD Checklist for DSM-5, PCL-5) and depressive symptoms.
Researchers will evaluate whether early screening scores are associated with later symptoms of childbirth-related PTSD and postpartum depression, and will assess the feasibility and acceptability of implementing routine inpatient screening for psychological birth trauma.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
Childbirth-related post-traumatic stress disorder (CB-PTSD) is increasingly recognized as a contributor to maternal morbidity and is more common among individuals who undergo unplanned cesarean delivery. Early identification of individuals at risk for CB-PTSD could allow timely referral to mental health support; however, screening for psychological birth trauma is not routinely performed in the immediate postpartum period.
This prospective observational cohort study will evaluate whether early postpartum screening tools can predict later PTSD symptoms following unplanned cesarean delivery. Participants will complete the Peritraumatic Distress Inventory (PDI), the City Birth Trauma Scale - Short Form (CityBiTS-SF), and the Edinburgh Postnatal Depression Scale (EPDS) within 24-48 hours postpartum. Follow-up surveys at 6 weeks and 3 months postpartum will assess PTSD symptoms using the PTSD Checklist for DSM-5 (PCL-5) and depressive symptoms using the EPDS.
The primary objective is to determine whether early postpartum screening scores on the PDI and CityBiTS-SF predict childbirth-related PTSD symptoms at 6 weeks postpartum. Secondary analyses will evaluate diagnostic performance of these tools, associations with postpartum depressive symptoms, and the feasibility of implementing routine postpartum screening for psychological birth trauma.
Tipo de estudio
De observación
Inscripción (Estimado)
420
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Katherine Seligman, MD
- Número de teléfono: 604-875-2158
- Correo electrónico: katie.seligman@cw.bc.ca
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3N1
- Reclutamiento
- BC Women's Hospital and Health Centre
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Contacto:
- Katherine Seligman, MD
- Número de teléfono: 6048752158
- Correo electrónico: katie.seligman@cw.bc.ca
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population consists of postpartum individuals who undergo an unplanned cesarean delivery at BC Women's Hospital & Health Centre, a tertiary maternity care center in Vancouver, Canada.
Descripción
Inclusion Criteria:
- Age ≥19 years
- Underwent unplanned cesarean delivery
- Able to provide informed consent
- Able to read and understand English questionnaires
Exclusion Criteria:
- Fetal or neonatal demise
- Unable to complete study questionnaires or provide informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Unplanned Cesarean Delivery Cohort
Postpartum individuals aged 19 years or older who undergo an unplanned cesarean delivery at BC Women's Hospital & Health Centre and consent to participate in the study.
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Participants complete validated screening questionnaires 24-48 hours postpartum, including the Peritraumatic Distress Inventory, City Birth Trauma Scale - Short Form, and Edinburgh Postnatal Depression Scale (EPDS).
Follow-up surveys at 6 weeks and 3 months postpartum include the PTSD Checklist for DSM-5, EPDS, and City Birth Trauma Scale - Long Form
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sensitivity of the Peritraumatic Distress Inventory (PDI ≥15) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum
Periodo de tiempo: 6 weeks postpartum
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Sensitivity of a Peritraumatic Distress Inventory score ≥15 obtained 24-48 hours postpartum for predicting childbirth-related post-traumatic stress symptoms at 6 weeks postpartum, defined as a PTSD Checklist for DSM-5 (PCL-5) score ≥33.
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6 weeks postpartum
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Sensitivity of the City Birth Trauma Scale - Short Form (CityBiTS-SF ≥4) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum
Periodo de tiempo: 6 weeks postpartum
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Sensitivity of a City Birth Trauma Scale - Short Form score ≥4 obtained 24-48 hours postpartum for predicting childbirth-related post-traumatic stress symptoms at 6 weeks postpartum, defined as a PTSD Checklist for DSM-5 (PCL-5) score ≥33.
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6 weeks postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic Accuracy of Early Postpartum Peritraumatic Distress Inventory (PDI) Screening for Childbirth-Related PTSD Symptoms
Periodo de tiempo: 6 weeks & 3 Months Postpartum
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Specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and area under the receiver operating characteristic curve for a Peritraumatic Distress Inventory score ≥15 obtained 24-48 hours postpartum for predicting childbirth-related PTSD symptoms defined as PTSD Checklist for DSM-5 (PCL-5) score ≥33.
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6 weeks & 3 Months Postpartum
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Diagnostic Accuracy of Early Postpartum City Birth Trauma Scale - Short Form (CityBiTS-SF) Screening for Childbirth-Related PTSD Symptoms
Periodo de tiempo: 6 weeks & 3 Months Postpartum
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Specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and area under the receiver operating characteristic curve for a City Birth Trauma Scale - Short Form score ≥4 obtained 24-48 hours postpartum for predicting childbirth-related PTSD symptoms defined as PTSD Checklist for DSM-5 (PCL-5) score ≥33.
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6 weeks & 3 Months Postpartum
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Association Between Early Peritraumatic Distress Inventory Scores and Postpartum Depression Symptoms
Periodo de tiempo: 6 weeks & 3 Months Postpartum
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Correlation and predictive accuracy of Peritraumatic Distress Inventory scores obtained 24-48 hours postpartum for identifying clinically significant postpartum depressive symptoms, defined as Edinburgh Postnatal Depression Scale score ≥13.
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6 weeks & 3 Months Postpartum
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Feasibility of Inpatient Postpartum Psychological Screening
Periodo de tiempo: 24-48 hours postpartum
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Feasibility will be evaluated by screening completion rates, administration time, and the proportion of eligible participants who complete psychological screening questionnaires within 24-48 hours postpartum.
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24-48 hours postpartum
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Participant Acceptability of Postpartum Psychological Screening
Periodo de tiempo: 24-48 hours postpartum
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Acceptability will be assessed using structured participant feedback surveys evaluating comfort with screening, perceived relevance, and perceived burden of completing screening questionnaires.
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24-48 hours postpartum
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Themes Associated with Traumatic Birth Experiences
Periodo de tiempo: 24-48 hours postpartum
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Qualitative thematic analysis of open-ended participant responses describing distressing or traumatic aspects of childbirth.
Themes will be identified using structured coding methods and summarized using frequency counts.
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24-48 hours postpartum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Horsch A, Garthus-Niegel S, Ayers S, Chandra P, Hartmann K, Vaisbuch E, Lalor J. Childbirth-related posttraumatic stress disorder: definition, risk factors, pathophysiology, diagnosis, prevention, and treatment. Am J Obstet Gynecol. 2024 Mar;230(3S):S1116-S1127. doi: 10.1016/j.ajog.2023.09.089. Epub 2024 Jan 9.
- Dopfer R, Niethammer D. Report on the international workshop of the Kind Philipp Foundation on late effects after bone marrow transplantation in childhood malignancies. Pediatr Hematol Oncol. 1993 Jan-Mar;10(1):63-84. doi: 10.3109/08880019309016530.
- Dekel S, Papadakis JE, Quagliarini B, Pham CT, Pacheco-Barrios K, Hughes F, Jagodnik KM, Nandru R. Preventing posttraumatic stress disorder following childbirth: a systematic review and meta-analysis. Am J Obstet Gynecol. 2024 Jun;230(6):610-641.e14. doi: 10.1016/j.ajog.2023.12.013. Epub 2023 Dec 18.
- Ayers S, Horsch A, Garthus-Niegel S, Nieuwenhuijze M, Bogaerts A, Hartmann K, Karlsdottir SI, Oosterman M, Tecirli G, Turner JD, Lalor J; COST Action CA18211. Traumatic birth and childbirth-related post-traumatic stress disorder: International expert consensus recommendations for practice, policy, and research. Women Birth. 2024 Mar;37(2):362-367. doi: 10.1016/j.wombi.2023.11.006. Epub 2023 Dec 8.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de mayo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
24 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos relacionados con el trauma y el estrés
- Enfermedades urogenitales
- Desordenes mentales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Trastornos del estado de ánimo
- Trastornos Puerperales
- Trastornos de Estrés, Traumáticos
- Desorden depresivo
- Depresión, Posparto
- Trastornos de estrés postraumático
Otros números de identificación del estudio
- H25-03700
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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