- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06042972
Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines (DeTaPoP)
Study Overview
Status
Conditions
Detailed Description
The majority of studies and literature on maternal psychology focus on mothers of infants and newborns. The psychological experience of mothers with older children is still yet to be one of the subjects covered in the research on maternal psychology.
Postpartum depression characterizes itself in a depressive episode without psychotic characteristics, where symptoms appear in the year following delivery.
These symptoms reach their peak between 3 and 6 weeks postpartum. The diagnosis of postpartum depression is made by health professionals with the help of questionnaires such as the Edinburgh Postnatal Depression Scale (EPDS) or the Patient Health Questionnaire 2 (PHQ2).
According to the last national perinatal survey from Santé Publique France (Edition 2021), the rate of women having postpartum depression was estimated at 16.7%.
In France, the current psychological follow-up exam for women after giving birth includes a postnatal interview which is systematically offered between the 4th and the 8th week after delivery. It can be followed by another interview between the 10th and 14th week postpartum if judged necessary by the healthcare provider. It can also be offered by request.
Currently, there are no screening consultations for postpartum depression beyond the 14th week postpartum. Health care professionals are trained to be vigilant in the 1st year postpartum but not beyond this time frame.
A multicentric Australian study based on 1,507 women described the prevalence of maternal depression from early pregnancy to 4 years postpartum. It also covered the risk factors for depressive symptoms at 4 years postpartum.
The study concluded that maternal depression is more common at 4 years postpartum than at any time in the first 12 months postpartum. The prevalence of depressive symptoms at 4 years postpartum was 14.5% which was higher than at any time-point in the first 12 months post partum.
Currently, no French study focuses on the number of women suffering from maternal depression beyond 12 months postpartum.
This study aims to assess the prevalence of women 1 to 4 years postpartum who are suspected to have maternal depression and its linked factors.
Depression in one's lifetime can lead to negative consequences on a mother's psychological health and her quality of life, as well as her children's health.
The impact on children can include physical or mental developmental delay, regressed cognitive or language development, and general infant health issues.
Thus, if this study shows a significant risk for women to develop delayed maternal depression, extending a psychological follow-up exam of women beyond the 1st year postpartum could be necessary.
Moreover, screening and treating these women could limit the consequences on their children's development and well-being.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Cyriane COURTOIS-B, DR
- Phone Number: +33 0139543712
- Email: etudedetapop@gmail.com
Study Contact Backup
- Name: Fatima IZEDAREN, CRA
- Phone Number: +33 0139637451
- Email: FIzedaren@hopitalporteverte.com
Study Locations
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Île-de-France
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Versailles, Île-de-France, France, 78000
- Recruiting
- Hôpital de la Porte Verte
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women over 18 years old
- Women from 1 year to 4 years postpartum or having children aged from 1 to 4 years old
- Patient gave their consent to participate in the study
- Patient lives in Yvelines
- Patient speaks and understands French
- Patient reads and writes in French
Exclusion Criteria:
- Patient suffered from postpartum depression in the 1st year after giving birth or is currently being treated for postpartum depression that started showing symptoms in the 1st year after giving birth.
- Patient is currently pregnant
- Patient gave birth less than 1 year prior or more than 4 years prior; or has a child who is less than one year old; or 5 or more years old
- Patient didn't give her consent to participate in the study
- Patient is under guardianship or judicial safeguard
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Postnatal Depression Scale and Patient Health Questionnaire 2
Time Frame: Through study completion, an average of 10 months
|
The primary outcome is positive if the Edinburgh Postnatal Depression Scale (EPDS) or the Patient Health Questionnaire 2 (PHQ2) are positive, meaning a score superior or equal to 10.5 for the EPDS or a score superior or equal to 3 for the PHQ2
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Through study completion, an average of 10 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
- Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14.
- Slomian J, Honvo G, Emonts P, Reginster JY, Bruyere O. Consequences of maternal postpartum depression: A systematic review of maternal and infant outcomes. Womens Health (Lond). 2019 Jan-Dec;15:1745506519844044. doi: 10.1177/1745506519844044. Erratum In: Womens Health (Lond). 2019 Jan-Dec;15:1745506519854864.
- Woolhouse H, Gartland D, Mensah F, Brown SJ. Maternal depression from early pregnancy to 4 years postpartum in a prospective pregnancy cohort study: implications for primary health care. BJOG. 2015 Feb;122(3):312-21. doi: 10.1111/1471-0528.12837. Epub 2014 May 21.
- Depression and Suicide Screening Gregory Plemmons MD, MFA, in Adolescent Health Screening: an Update in the Age of Big Data, 2019
- Référentiel de psychiatrie. Collège national des universitaires en psychiatrie. Presses universitaires François Rabelais, 3ème édition, 2021
- Guedeney N, Fermanian J. Validation study of the French version of the Edinburgh Postnatal Depression Scale (EPDS): new results about use and psychometric properties. Eur Psychiatry. 1998;13(2):83-9. doi: 10.1016/S0924-9338(98)80023-0.
- Murray L, Carothers AD. The validation of the Edinburgh Post-natal Depression Scale on a community sample. Br J Psychiatry. 1990 Aug;157:288-90. doi: 10.1192/bjp.157.2.288.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- mental health
- primary care
- postpartum depression
- depressive disorder
- postnatal depression
- behavioral symptoms
- mental disorder
- pregnancy complications
- social health
- Edinburgh postnatal depression scale
- EPDS
- patient health questionnaire
- PHQ2
- puerperal disorders
- moods disorders
- maternity complications
- maternity
- maternal distress
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A01411-44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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