Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines (DeTaPoP)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06042972 |
|
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : March 19, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Post Partum Depression | Other: Questionnaire including Edinburgh postnatal depression scale, Patient Health Questionnaire 2 and background variables |
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 : | Observational |
| Estimated Enrollment : | 800 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines |
| Actual Study Start Date : | September 30, 2023 |
| Estimated Primary Completion Date : | October 30, 2024 |
| Estimated Study Completion Date : | October 30, 2024 |
- Other: Questionnaire including Edinburgh postnatal depression scale, Patient Health Questionnaire 2 and background variables
Patients meeting the inclusion criteria will be recruited by health professionals who have agreed to participate in the study.
Patients must fill out an anonymous self-questionnaire which will consist of 2 tests aimed to help diagnose postpartum depression, recommended in France by the Haute Autorité de Santé (HAS), and background variables.
The self-questionnaire will be given back by the patient in a sealed envelope. Each questionnaire will only be filled out once per patient.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042972
| Contact: Cyriane COURTOIS-B, DR | 0139543712 ext +33 | etudedetapop@gmail.com | |
| Contact: Fatima IZEDAREN, CRA | 0139637451 ext +33 | FIzedaren@hopitalporteverte.com |
| France | |
| Hôpital de la Porte Verte | Recruiting |
| Versailles, Île-de-France, France, 78000 | |
Publications:
| Responsible Party: | Cyriane Courtois, Principal Investigator, Centre Médical Porte Verte |
| ClinicalTrials.gov Identifier: | NCT06042972 |
| Other Study ID Numbers: |
2023-A01411-44 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | March 19, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
postpartum depression depressive disorder mental disorder Edinburgh postnatal depression scale EPDS patient health questionnaire PHQ2 pregnancy complications puerperal disorders |
moods disorders maternity complications behavioral symptoms maternity maternal distress mental health postnatal depression social health primary care |
|
Depression, Postpartum Depression Depressive Disorder Behavioral Symptoms Mood Disorders |
Mental Disorders Puerperal Disorders Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |