Childbirth-related PTSDNCT07159516
Identifying Birth-Related PTSD: Cutoffs for the City Birth Trauma Scale
An observational study of Childbirth-related PTSD and PTSD, run by Region Östergötland at 1 site in Sweden.
Trial summary
A total of 67 people were recruited from maternity units and social media to take part in the study. They first completed an online questionnaire, then filled out the CityBiTS measure, and finally took part in a diagnostic interview over the phone. 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, PTSD (Childbirth-Related)
- What is being tested?
- Diagnostic interview
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2023to 1 Nov 2024
- 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: Recruitment was performed from a risk group of individuals with a higher likelihood of having BR-PTSD than the average population, to decrease the number of needed diagnostic interviews. Recruitment was made achieved via two different paths. Since birth complications are important risk factors for BR-PTSD, individuals with documented medical complications during birth were recruited from nine birth units in different parts of Sweden for the first path. These were identified by the following diagnostic codes in medical records. Those meeting inclusion criteria were invited by postal mail, including information about the study as well as a link and QR-code to the first survey. The second recruitment path was via social media. The ad invited those who had recently given birth and experienced the birth as difficult.
Who may be able to join
- age 18 or more
- who had given birth with a minimum at four weeks prior to completing CityBiTS,
- who had a sufficient level of Swedish to participate.
Who cannot join
- Cases of stillbirth
Trial locations and contacts
1 site in 1 country.
About this study
A total of 67 people were recruited from maternity units and social media to take part in the study. They first completed an online questionnaire, then filled out the CityBiTS measure, and finally took part in a diagnostic interview over the phone. The CityBiTS scores were compared to the results of the interviews using ROC curve analysis. We looked at how well the scores identified cases (sensitivity), correctly identified non-cases (specificity), and overall accuracy to find the best cutoff scores and see how these compared to other available methods.
- Conditions
- Childbirth-related PTSD, PTSD, PTSD (Childbirth-Related), PTSD - Post Traumatic Stress Disorder, Post Traumatic Stress
- Being tested
- Diagnostic interview
- Keywords
- PTSD, childbirth, cut-off, CityBits, sensitivity, specificity, Diagnostic Interview, ROC curve
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic interviewDiagnostic test
SCID-5 Clinician Version (SCID-5-CV) was used as gold standard method for determining if diagnostic criteria of PTSD was met or not (First, 2023). SCID-5-CV has been validated for use via telephone with good results for PTSD (Osorio et al., 2019). Only the PTSD-chapter was used, and exclusively birth-related traumatic experiences were considered. This was done achieved by adding a question to the interview guide, addressing potentially traumatic experiences associated with healthcare during a physical examination, operation, intensive care or childbirth.
| Study group | Role | What they receive |
|---|---|---|
| Individuals recruited from birth units and social media who recently gave birth | Not described Receives: Diagnostic Test: Diagnostic interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants fulfilling the diagnostic criteria for BR-PTSD based on the diagnostic interview compared to CityBiTS
Measured: Day 1
Secondary outcomes (1)
Cut-offs for CityBits
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Nov 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
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
- 67 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
- NCT07159516
- Sponsor's protocol ID
- Dnr 2023-04534-01
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Birth-Related PTSD: Cutoffs for the City Birth Trauma Scale
- ClinicalTrials.gov ID
- NCT07159516
- Acronym / sponsor ID
- Dnr 2023-04534-01
- Conditions
- Childbirth-related PTSD, PTSD, PTSD (Childbirth-Related), PTSD - Post Traumatic Stress Disorder, Post Traumatic Stress
- Keywords
- PTSD, childbirth, cut-off, CityBits, sensitivity, specificity, Diagnostic Interview, ROC curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 Sep 2025 (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.
A total of 67 people were recruited from maternity units and social media to take part in the study. They first completed an online questionnaire, then filled out the CityBiTS measure, and finally took part in a diagnostic interview over the phone. The CityBiTS scores were compared to the results of the interviews using ROC curve analysis. We looked at how well the scores identified cases (sensitivity), correctly identified non-cases (specificity), and overall accuracy to find the best cutoff scores and see how these compared to other available methods.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals recruited from birth units and social media who recently gave birth | – | Diagnostic Test: Diagnostic interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Recruitment was performed from a risk group of individuals with a higher likelihood of having BR-PTSD than the average population, to decrease the number of needed diagnostic interviews. Recruitment was made achieved via two different paths. Since birth complications are important risk factors for BR-PTSD, individuals with documented medical complications during birth were recruited from nine birth units in different parts of Sweden for the first path. These were identified by the following diagnostic codes in medical records. Those meeting inclusion criteria were invited by postal mail, including information about the study as well as a link and QR-code to the first survey. The second recruitment path was via social media. The ad invited those who had recently given birth and experienced the birth as difficult.
Key inclusion criteria (3 listed)
- age 18 or more
- who had given birth with a minimum at four weeks prior to completing CityBiTS,
- who had a sufficient level of Swedish to participate.
Key exclusion criteria (1 listed)
- Cases of stillbirth
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 |
|---|---|---|
| Diagnostic interviewSCID-5 Clinician Version (SCID-5-CV) was used as gold standard method for determining if diagnostic criteria of PTSD was met or not (First, 2023). SCID-5-CV has been validated for use via telephone with good results for PTSD (Osorio et al., 2019). Only the PTSD-chapter was used, and exclusively birth-related traumatic experiences were considered. This was done achieved by adding a question to the interview guide, addressing potentially traumatic experiences associated with healthcare during a physical examination, operation, intensive care or childbirth. | Diagnostic test | Individuals recruited from birth units and social media who recently gave birth |
Primary outcome
Number of participants fulfilling the diagnostic criteria for BR-PTSD based on the diagnostic interview compared to CityBiTS
Time frame: Day 1
1 secondary outcome
Cut-offs for CityBits
Time frame: up to 6 months
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 8 Sep 2025.
- 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?
The sponsor lists 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 2025. 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?
Number of participants fulfilling the diagnostic criteria for BR-PTSD based on the diagnostic interview compared to CityBiTS (time frame: Day 1). 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 8 Sep 2025.