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RecruitingNCT06042972DeTaPoPUpdated Mar 19, 2024

Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines

An observational study in Post Partum Depression, sponsored by Centre Médical Porte Verte. Recruiting at 1 site in France. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Centre Médical Porte Verte · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 65 Years
Sex
Female
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Study summary

This observational study aims to estimate the prevalence of women from 1 to 4 years postpartum in Yvelines, who are suspected to suffer from postpartum depression, using the Edinburg Post natal Depression Scale (EPDS) and the Patient Heath Questionnaire 2 (PHQ2) and evaluate the factors that could be linked to it.

Read the 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.

02

Conditions studied

  • Post Partum Depression

Keywords

  • 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
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's planned enrollment of 800 is above the median of 200 across 88 observational studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Centre Médical Porte Verte is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Mothers of children aged from 1 year to 4 years living in Yvelines

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestionnaire 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.

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What researchers measure

Primary outcomes

  1. Edinburgh Postnatal Depression Scale and Patient Health Questionnaire 2

    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

    Time frame: Through study completion, an average of 10 months

07

Study locations

1 of 1 sites recruiting
  • Hôpital de la Porte Verte
    Versailles, Île-de-France 78000, France
    Recruiting
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References and documents

Publications

  • 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. PubMed 24844913 ↗
  • 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. doi: 10.1177/1745506519854864. PubMed 31035856 ↗
  • 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. PubMed 25455250 ↗
  • 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
  • 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. PubMed 14583691 ↗
  • 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. PubMed 3651732 ↗
  • 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. PubMed 19698604 ↗
  • 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. PubMed 2224383 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06042972
Lead sponsor
Centre Médical Porte Verte
Responsible party
Cyriane Courtois (Principal Investigator, Centre Médical Porte Verte) — Principal investigator
First posted
Sep 21, 2023
Start date
Sep 30, 2023
Primary completion
Oct 30, 2024 (estimated)
Completion
Oct 30, 2024 (estimated)
Last update
Mar 19, 2024

Study contacts

Cyriane COURTOIS-B, DR
Contact
etudedetapop@gmail.com
0139543712 ext. +33
Fatima IZEDAREN, CRA
Contact
FIzedaren@hopitalporteverte.com
0139637451 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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