Depression, PostpartumDEPRESSIONPPNCT06469476
Evaluation of Access to Screening for Post-partum Depression Via the Postnatal Interview Within 8 Weeks of Birth in Women Who Have Gave Birth at the Troyes Hospital ( DEPRESSIONPP )
An observational study of Depression, Postpartum, run by Centre Hospitalier de Troyes at 1 site in France.
Trial summary
Post-partum depression is defined as a depressive disorder with onset of symptoms in the year following childbirth. Several international studies have reported a prevalence of this condition of around pathology of around 15%. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- depression post partum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 31 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: the adult women who have given birth at the Centre Hospitalier de Troyes between July 2022 and October 2023.
Who may be able to join
- The study will include adult women who have given birth at the Centre hospitalier de Troyes from July 2022 to October 2023
- and agreeing to take part in the study.
- non inclusion criteria
- minors under the age of 18
- those protected by law (guardianship, curatorship and safeguard of justice)
- patients refusing to take part in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Troyes
Troyes, Grand Est, 10000
Stéphane Sanchez, MD, 0625036892
About this study
Post-partum depression is defined as a depressive disorder with onset of symptoms in the year following childbirth. Several international studies have reported a prevalence of this condition of around pathology of around 15%. Santé publique France's 2021 national perinatal survey corroborated these figures, finding a prevalence of post-partum depression in France of in France of 16.7%. It is therefore a frequent pathology that can cause complications for both mother and child.
The complications both for the mother and for the mother-child bond. Indeed, post-partum depression can lead to an increased risk of infanticide, weaker mother-child attachment, and altered parental behaviour. post-partum depression can lead to maternal suicide (the second leading cause cause of maternal mortality in France). Despite the potential seriousness of severe depression and its impact on the on the mother-child bond, just under half of those suffering from severe depression suffering from severe depression consult a healthcare professional.
Read more
Fear of being judged or stigmatised, linked to misperceptions about the episode, is one of the main obstacles to consultation.
Of being judged or stigmatised, linked to erroneous representations of the depressive episode. Given the scale of this condition, and the difficulties young mothers face in seeking help for young mothers to seek help, it is vital to screen postpartum women as widely and post-partum women as early as possible. In view of the extent of this condition and the difficulties young mothers have in seeking help for young mothers, it is vital to screen post-partum women as widely and as post-partum. With this in mind, from July 2022, a compulsory early post-natal interview has been introduced, designed to screen for postpartum depression.
Read the detailed description
Main objective: To evaluate the associated factors, in particular referral by a professional as a determinant of whether or not the 'compulsory' early interview.
Secondary objective: To assess the economic, geographical and other factors associated and other factors associated with the compulsory early postnatal interview. Type of study: Observational, retrospective study. Population: Women who gave birth at the Centre Hospitalier de Troyes from July 2022 to October 2023. Assessment criteria : To be referred or not by a health professional during the early postnatal interview. Investigation plan: Send the information note and no objection to all eligible eligible women, together with the questionnaire and a T envelope to return the completed questionnaire. Inclusion criteria The study will include adult women who have given birth at the Centre hospitalier de Troyes between July 2022 and October 2023 and agreeing to take part in the study. Non-inclusion criteria The following will not be included in the study
- minors under the age of 18
- those protected by law (guardianship, curatorship and safeguard of justice)
- patients refusing to participate in the study
- Conditions
- Depression, Postpartum
- Being tested
- depression post partum
- Keywords
- depression post partum
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depression post partumBehavioural
visit post partum
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure if the patient is yes or not to be referred by a healthcare professional during the early postnatal interview.
question
Measured: 3 months
Secondary outcomes (4)
Measure the socio-economic status
financial parameter
Measured: 3 months
measure the declaration of a financial or non-financial obstacle
financial parameter
Measured: 3 months
measure the knowledge about post-partum depression
question first contact
Measured: 3 months
measure the knowledge about early post-natal interview.
question
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Troyes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amjad KATTINI, DR, Principal investigator, Centre Hospitalier de Troyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469476
- Sponsor's protocol ID
- 2023-A02394-41
- Acronym
- DEPRESSIONPP
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Access to Screening for Post-partum Depression Via the Postnatal Interview Within 8 Weeks of Birth in Women Who Have Gave Birth at the Troyes Hospital ( DEPRESSIONPP )
- ClinicalTrials.gov ID
- NCT06469476
- Acronym / sponsor ID
- DEPRESSIONPP / 2023-A02394-41
- Conditions
- Depression, Postpartum
- Keywords
- depression post partum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier de TroyesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 21 Jun 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.
Post-partum depression is defined as a depressive disorder with onset of symptoms in the year following childbirth. Several international studies have reported a prevalence of this condition of around pathology of around 15%. Santé publique France's 2021 national perinatal survey corroborated these figures, finding a prevalence of post-partum depression in France of in France of 16.7%. It is therefore a frequent pathology that can cause complications for both mother and child.
The complications both for the mother and for the mother-child bond. Indeed, post-partum depression can lead to an increased risk of infanticide, weaker mother-child attachment, and altered parental behaviour. post-partum depression can lead to maternal suicide (the second leading cause cause of maternal mortality in France). Despite the potential seriousness of severe depression and its impact on the on the mother-child bond, just under half of those suffering from severe depression suffering from severe depression consult a healthcare professional.
Fear of being judged or stigmatised, linked to misperceptions about the episode, is one of the main obstacles to consultation.
Of being judged or stigmatised, linked to erroneous representations of the depressive episode. Given the scale of this condition, and the difficulties young mothers face in seeking help for young mothers to seek help, it is vital to screen postpartum women as widely and post-partum women as early as possible. In view of the extent of this condition and the difficulties young mothers have in seeking help for young mothers, it is vital to screen post-partum women as widely and as post-partum. With this in mind, from July 2022, a compulsory early post-natal interview has been introduced, designed to screen for postpartum depression.
Detailed description
Main objective: To evaluate the associated factors, in particular referral by a professional as a determinant of whether or not the 'compulsory' early interview.
Secondary objective: To assess the economic, geographical and other factors associated and other factors associated with the compulsory early postnatal interview. Type of study: Observational, retrospective study. Population: Women who gave birth at the Centre Hospitalier de Troyes from July 2022 to October 2023. Assessment criteria : To be referred or not by a health professional during the early postnatal interview. Investigation plan: Send the information note and no objection to all eligible eligible women, together with the questionnaire and a T envelope to return the completed questionnaire. Inclusion criteria The study will include adult women who have given birth at the Centre hospitalier de Troyes between July 2022 and October 2023 and agreeing to take part in the study. Non-inclusion criteria The following will not be included in the study
- minors under the age of 18
- those protected by law (guardianship, curatorship and safeguard of justice)
- patients refusing to participate in the study
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the adult women who have given birth at the Centre Hospitalier de Troyes between July 2022 and October 2023.
Key inclusion criteria (6 listed)
- The study will include adult women who have given birth at the Centre hospitalier de Troyes from July 2022 to October 2023
- and agreeing to take part in the study.
- non inclusion criteria
- minors under the age of 18
- those protected by law (guardianship, curatorship and safeguard of justice)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| depression post partumvisit post partum | Behavioural | – |
Primary outcome
Measure if the patient is yes or not to be referred by a healthcare professional during the early postnatal interview.
Time frame: 3 months
question
4 secondary outcomes
Measure the socio-economic status
Time frame: 3 months
measure the declaration of a financial or non-financial obstacle
Time frame: 3 months
measure the knowledge about post-partum depression
Time frame: 3 months
measure the knowledge about early post-natal interview.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- 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. This study is not recruiting at the moment.
Amjad KATTINI, DR principal investigator
Centre Hospitalier de Troyes
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 Depression, Postpartum, run by Centre Hospitalier de Troyes 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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Sanchez, DR (0325497561, recherche.clinique@hcs-sante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure if the patient is yes or not to be referred by a healthcare professional during the early postnatal interview. (time frame: 3 months). 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 21 Jun 2024.