Clinical trial NCT06042972: Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines
Official title: Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Centre Médical Porte Verte
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers of children aged from 1 year to 4 years living in Yvelines

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale and Patient Health Questionnaire 2
timeFrame: Through study completion, an average of 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Versailles
country: France
facility: Hôpital de la Porte Verte
state: Île-de-France
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Depression and Suicide Screening Gregory Plemmons MD, MFA, in Adolescent Health Screening: an Update in the Age of Big Data, 2019
citation: Référentiel de psychiatrie. Collège national des universitaires en psychiatrie. Presses universitaires François Rabelais, 3ème édition, 2021
citation: 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.
citation: 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.
citation: 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.
citation: 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.