Post Traumatic Stress DisorderPREDICTNCT07561632
Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery
An observational study of Post Traumatic Stress Disorder and Post Partum Depression, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Post Traumatic Stress Disorder, Post Partum Depression, Acute Stress Symptoms
- What is being tested?
- Postpartum Psychological Screening
- How many people
- 420 participants
- Where
- 1 siteCanada
- Study dates
- 8 May 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥19 years
- Underwent unplanned cesarean delivery
- Able to provide informed consent
- Able to read and understand English questionnaires
Who cannot join
- Fetal or neonatal demise
- Unable to complete study questionnaires or provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Women's Hospital and Health Centre
Vancouver, British Columbia, V6H 3N1
Katherine Seligman, MD, 6048752158, katie.seligman@cw.bc.ca
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- Postpartum Psychological Screening
- Keywords
- Childbirth Related PTSD, Psychological birth trauma, Peritraumatic Distress Inventory, City Birth Trauma Scale
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Psychological ScreeningOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Postpartum Psychological Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Peritraumatic Distress Inventory (PDI ≥15) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum
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.
Measured: 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
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.
Measured: 6 weeks postpartum
Secondary outcomes (6)
Diagnostic Accuracy of Early Postpartum Peritraumatic Distress Inventory (PDI) Screening for Childbirth-Related PTSD Symptoms
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.
Measured: 6 weeks & 3 Months Postpartum
Diagnostic Accuracy of Early Postpartum City Birth Trauma Scale - Short Form (CityBiTS-SF) Screening for Childbirth-Related PTSD Symptoms
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.
Measured: 6 weeks & 3 Months Postpartum
Association Between Early Peritraumatic Distress Inventory Scores and Postpartum Depression Symptoms
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.
Measured: 6 weeks & 3 Months Postpartum
Feasibility of Inpatient Postpartum Psychological Screening
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.
Measured: 24-48 hours postpartum
Participant Acceptability of Postpartum Psychological Screening
Acceptability will be assessed using structured participant feedback surveys evaluating comfort with screening, perceived relevance, and perceived burden of completing screening questionnaires.
Measured: 24-48 hours postpartum
Themes Associated with Traumatic Birth Experiences
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.
Measured: 24-48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start8 May 2026
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Responsible party
- Principal investigator, Katherine Seligman, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561632
- Sponsor's protocol ID
- H25-03700
- Acronym
- PREDICT
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 8443054Dekel 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.
PubMed 38122842Horsch 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.
PubMed 38233316Ayers 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.
PubMed 38071102
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07561632
- Acronym / sponsor ID
- PREDICT / H25-03700
- Keywords
- Childbirth Related PTSD, Psychological birth trauma, Peritraumatic Distress Inventory, City Birth Trauma Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Study start
- 8 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unplanned Cesarean Delivery Cohort | – | Other: Postpartum Psychological ScreeningPostpartum 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥19 years
- Underwent unplanned cesarean delivery
- Able to provide informed consent
- Able to read and understand English questionnaires
Key exclusion criteria (2 listed)
- Fetal or neonatal demise
- Unable to complete study questionnaires or provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum Psychological ScreeningParticipants 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 | Other | Unplanned Cesarean Delivery Cohort |
Primary outcome
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 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.
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
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 8443054Dopfer 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.
- Background: PubMed 38122842Dekel 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.
- Background: PubMed 38233316Horsch 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.
- Background: PubMed 38071102Ayers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Post Partum Depression, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Seligman, MD (604-875-2158, katie.seligman@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Peritraumatic Distress Inventory (PDI ≥15) for Predicting Childbirth-Related PTSD Symptoms at 6 Weeks Postpartum (time frame: 6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561632, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.