NCT07561632

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2028

Study Start

First participant enrolled

April 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Childbirth Related PTSDPsychological birth traumaPeritraumatic Distress InventoryCity Birth Trauma Scale

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 weeks postpartum

Secondary Outcomes (6)

  • Diagnostic Accuracy of Early Postpartum Peritraumatic Distress Inventory (PDI) Screening for Childbirth-Related PTSD Symptoms

    6 weeks & 3 Months Postpartum

  • Diagnostic Accuracy of Early Postpartum City Birth Trauma Scale - Short Form (CityBiTS-SF) Screening for Childbirth-Related PTSD Symptoms

    6 weeks & 3 Months Postpartum

  • Association Between Early Peritraumatic Distress Inventory Scores and Postpartum Depression Symptoms

    6 weeks & 3 Months Postpartum

  • Feasibility of Inpatient Postpartum Psychological Screening

    24-48 hours postpartum

  • Participant Acceptability of Postpartum Psychological Screening

    24-48 hours postpartum

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Postpartum Psychological Screening

Interventions

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

Unplanned Cesarean Delivery Cohort

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age ≥19 years
  • Underwent unplanned cesarean delivery
  • Able to provide informed consent
  • Able to read and understand English questionnaires

You may not qualify if:

  • Fetal or neonatal demise
  • Unable to complete study questionnaires or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (4)

  • 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: 8443054BACKGROUND
  • 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: 38122842BACKGROUND
  • 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: 38233316BACKGROUND
  • 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: 38071102BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression, Postpartum

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Central Study Contacts

Katherine Seligman, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Katherine M. Seligman MD FRCPC D.ABA

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations