Childbirth-related Post-traumatic Stress DisorderSSPT-ANCT07827508
Assessment of Childbirth-Related Post-Traumatic Stress Disorder
A study testing City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization in people with Childbirth-related Post-traumatic Stress Disorder, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial summary
The main objective of this study is to estimate the prevalence of childbirth-related post-traumatic stress disorder (PTSD) among mothers treated at the maternity ward of Emile Muller Hospital (Mulhouse, Haut-Rhin, France). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth-related Post-traumatic Stress Disorder
- What is being tested?
- City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 or older
- Having given birth in the maternity ward at Emile Muller Hospital (Mulhouse, Haut-Rhin, France)
- Fluent in French
- Having provided written consent to participate in the study
- Being covered by a social security program
Who cannot join
- Women who gave birth anonymously
- Women who gave birth to a stillborn child or a fetus that died in utero
- Women under legal protection (guardianship, conservatorship, judicial protection).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Mulhouse, 68100
About this study
Official title: Assessment of Childbirth-Related Post-Traumatic Stress Disorder: A Single-Center Prospective Study
The main objective of this study is to estimate the prevalence of childbirth-related post-traumatic stress disorder (PTSD) among mothers treated at the maternity ward of Emile Muller Hospital (Mulhouse, Haut-Rhin, France).
Read the detailed description
Secondary objectives
- To identify risk factors associated with the development of PTSD, in order to determine which situations-particularly obstetric ones-could lead women to experience trauma, and understand the underlying psychological mechanisms. Risk factors identified in the literature or deemed relevant by the study's clinicians and psychologists will be gathered from medical records.
- To assess healthcare utilization in the context of the onset of childbirth-related PTSD from the women's perspective, using a questionnaire consisting of a series of questions about the different healthcare professionals consulted during the month following childbirth.
Conduct of research About one month after giving birth, women who have provided their consent will receive an email containing a personal link to the eCRF page where they will find the French version of the "City Birth Trauma Scale" (CBTS) questionnaire, as well as the questionnaire designed to assess their use of healthcare services.
After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD.
If the participant has not completed the questionnaire within 10 days of receiving the link, a follow-up email will be sent to her. If, after receiving this follow-up email, the participant has not completed the questionnaire or contacted the research team, she will be considered lost to follow-up.
- Being tested
- City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization
- Keywords
- Parturition, Post Traumatic Stress Disorder, Screening, City Birth Trauma Scale
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilizationDiagnostic test
About one month after giving birth, patients who have given their consent will receive an email containing a personal link to the eCRF page with the French version of the City Birth Trauma Scale (CBTS) questionnaire, as well as a questionnaire to assess their use of healthcare services.
After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD.
| Study group | Role | What they receive |
|---|---|---|
| Women who have given birth within the past month | Other | Not described Receives: Diagnostic Test: City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
City Birth Trauma Scale
The diagnosis of PTSD based on responses to the questionnaire will be made in accordance with the questionnaire's scoring method, which assesses 8 criteria based on the DSM-5 (criteria labeled A through H).
Measured: About 1 month after childbirth
Secondary outcomes (1)
Questionnaire on the assessment of healthcare utilization
A ten-item questionnaire to assess the use of healthcare services in the context of postpartum post-traumatic stress disorder from the women's perspective, enquiring about the healthcare professionals these women consulted during the month following childbirth.
Measured: About 1 month after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth-related Post-traumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Women who have given birth within the past month
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827508
- Sponsor's protocol ID
- GHRMSA 1497
- Other IDs
- ID-RCB 2026-A00733-48
- Acronym
- SSPT-A
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Childbirth-Related Post-Traumatic Stress Disorder: A Single-Center Prospective Study
- ClinicalTrials.gov ID
- NCT07827508
- Acronym / sponsor ID
- SSPT-A / GHRMSA 1497
- Keywords
- Parturition, Post Traumatic Stress Disorder, Screening, City Birth Trauma Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Sep 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 main objective of this study is to estimate the prevalence of childbirth-related post-traumatic stress disorder (PTSD) among mothers treated at the maternity ward of Emile Muller Hospital (Mulhouse, Haut-Rhin, France).
Detailed description
Secondary objectives
- To identify risk factors associated with the development of PTSD, in order to determine which situations-particularly obstetric ones-could lead women to experience trauma, and understand the underlying psychological mechanisms. Risk factors identified in the literature or deemed relevant by the study's clinicians and psychologists will be gathered from medical records.
- To assess healthcare utilization in the context of the onset of childbirth-related PTSD from the women's perspective, using a questionnaire consisting of a series of questions about the different healthcare professionals consulted during the month following childbirth.
Conduct of research About one month after giving birth, women who have provided their consent will receive an email containing a personal link to the eCRF page where they will find the French version of the "City Birth Trauma Scale" (CBTS) questionnaire, as well as the questionnaire designed to assess their use of healthcare services.
After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD.
If the participant has not completed the questionnaire within 10 days of receiving the link, a follow-up email will be sent to her. If, after receiving this follow-up email, the participant has not completed the questionnaire or contacted the research team, she will be considered lost to follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Women who have given birth within the past month
| Arm | Type | Receives |
|---|---|---|
| Women who have given birth within the past month | Other | Diagnostic Test: City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 or older
- Having given birth in the maternity ward at Emile Muller Hospital (Mulhouse, Haut-Rhin, France)
- Fluent in French
- Having provided written consent to participate in the study
- Being covered by a social security program
Key exclusion criteria (3 listed)
- Women who gave birth anonymously
- Women who gave birth to a stillborn child or a fetus that died in utero
- Women under legal protection (guardianship, conservatorship, judicial protection).
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 |
|---|---|---|
| City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilizationAbout one month after giving birth, patients who have given their consent will receive an email containing a personal link to the eCRF page with the French version of the City Birth Trauma Scale (CBTS) questionnaire, as well as a questionnaire to assess their use of healthcare services. After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD. | Diagnostic test | Women who have given birth within the past month |
Primary outcome
City Birth Trauma Scale
Time frame: About 1 month after childbirth
The diagnosis of PTSD based on responses to the questionnaire will be made in accordance with the questionnaire's scoring method, which assesses 8 criteria based on the DSM-5 (criteria labeled A through H).
1 secondary outcome
Questionnaire on the assessment of healthcare utilization
Time frame: About 1 month after childbirth
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 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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?
A study testing City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization in people with Childbirth-related Post-traumatic Stress Disorder, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Sep 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 France. 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 Edgar Yohny Montoya Ramirez, MD (+33 3 89 64 64 64, montoyaramireze@ghrmsa.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
City Birth Trauma Scale (time frame: About 1 month after childbirth). 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 18 Sep 2026.