NCT06207916

Brief Summary

The goal of this cross-sectional observational study is to analyze childbirth-related PTSD, traumatic birth experiences and stress symptoms postpartum. The main questions it aims to answer are:

  • What is the prevalence of traumatic birth experiences, PTSD and stress symptoms in a Swedish postnatal sample?
  • What are the risk factors for postnatal mental ill-health? Additional goals are to make cross-cultural translations of the instruments City BiTS and Birth Satisfaction Scale - Revised. Participants will answer an online surveys including several instruments measuring postnatal stress and mental ill-health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
619

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 5, 2024

Last Update Submit

January 5, 2024

Conditions

Childbirth-related PTSDPTSDPostnatal DepressionFear of ChildbirthPost Traumatic Stress DisorderPostpartum Sadness

Outcome Measures

Primary Outcomes (1)

  • Prevalence of childbirth-related PTSD

    2022

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women who had given birth at the participated clinics and whom answered to the inclusion and exclusion criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrinnevisjukhuset

Norrköping, Sweden

Location

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

September 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)