- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07561632
Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery (PREDICT)
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Katherine Seligman, MD
- Numéro de téléphone: 604-875-2158
- E-mail: katie.seligman@cw.bc.ca
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- Recrutement
- BC Women's Hospital and Health Centre
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Contact:
- Katherine Seligman, MD
- Numéro de téléphone: 6048752158
- E-mail: katie.seligman@cw.bc.ca
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensitivity of the Peritraumatic Distress Inventory (PDI ≥15) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diagnostic Accuracy of Early Postpartum Peritraumatic Distress Inventory (PDI) Screening for Childbirth-Related PTSD Symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles liés aux traumatismes et aux facteurs de stress
- Maladies urogénitales
- Les troubles mentaux
- Maladies urogénitales féminines et complications de la grossesse
- Complications de grossesse
- Troubles de l'humeur
- Troubles puerpéraux
- Troubles de stress, traumatiques
- Dépression
- Dépression, post-partum
- Troubles de stress, post-traumatique
Autres numéros d'identification d'étude
- H25-03700
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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