Recruiting NCT07561632

Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery

— Observational Post Traumatic Stress Disorder Post Partum Depression Acute Stress Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Postpartum Psychological Screening.
Who it may be relevant to: Registry conditions: Post Traumatic Stress Disorder, Post Partum Depression, Acute Stress Symptoms. Basic parameters: from 19 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Canada
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

Other Postpartum Psychological Screening
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

Primary outcome measures

Sensitivity of the Peritraumatic Distress Inventory (PDI ≥15) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum [Time frame: 6 weeks postpartum]
Sensitivity of the City Birth Trauma Scale - Short Form (CityBiTS-SF ≥4) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum [Time frame: 6 weeks postpartum]

Secondary outcome measures (6)

Diagnostic Accuracy of Early Postpartum Peritraumatic Distress Inventory (PDI) Screening for Childbirth-Related PTSD Symptoms [Time frame: 6 weeks & 3 Months Postpartum]
Diagnostic Accuracy of Early Postpartum City Birth Trauma Scale - Short Form (CityBiTS-SF) Screening for Childbirth-Related PTSD Symptoms [Time frame: 6 weeks & 3 Months Postpartum]
Association Between Early Peritraumatic Distress Inventory Scores and Postpartum Depression Symptoms [Time frame: 6 weeks & 3 Months Postpartum]
Feasibility of Inpatient Postpartum Psychological Screening [Time frame: 24-48 hours postpartum]
Participant Acceptability of Postpartum Psychological Screening [Time frame: 24-48 hours postpartum]
Themes Associated with Traumatic Birth Experiences [Time frame: 24-48 hours postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Canada · 1 center

BC Women's Hospital and Health Centre — Vancouver

Publications

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. PMID 8443054
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. PMID 38122842
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. PMID 38233316
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. PMID 38071102

Identifiers

NCT: NCT07561632 · H25-03700

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗