Childbirth-related PTSDSwIntersectNCT06207916
International Survey of Childbirth-Related Trauma - Swedish Part
An observational study of Childbirth-related PTSD and PTSD, run by Region Östergötland at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth-related PTSD, PTSD, Postnatal Depression
- How many people
- 619 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Adult, Older adult
Study population: All women who had given birth at the participated clinics and whom answered to the inclusion and exclusion criteria
Inclusion Criteria: having given birth 6-16 weeks previously -
Exclusion Criteria: having given birth to a child that did not survive
-
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Childbirth-related PTSD, PTSD, Postnatal Depression, Fear of Childbirth, Post Traumatic Stress Disorder, Postpartum Sadness
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of childbirth-related PTSD
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth-related PTSDStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Grundström, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207916
- Sponsor's protocol ID
- SwIntersect
- Acronym
- SwIntersect
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Survey of Childbirth-Related Trauma - Swedish Part
- ClinicalTrials.gov ID
- NCT06207916
- Acronym / sponsor ID
- SwIntersect / SwIntersect
- Conditions
- Childbirth-related PTSD, PTSD, Postnatal Depression, Fear of Childbirth, Post Traumatic Stress Disorder, Postpartum Sadness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 17 Jan 2024 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All women who had given birth at the participated clinics and whom answered to the inclusion and exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of childbirth-related PTSD
Time frame: 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Childbirth-related PTSD and PTSD, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Jan 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of childbirth-related PTSD (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2024.