NCT06042972

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

September 6, 2023

Last Update Submit

March 16, 2024

Conditions

Keywords

postpartum depressiondepressive disordermental disorderEdinburgh postnatal depression scaleEPDSpatient health questionnairePHQ2pregnancy complicationspuerperal disordersmoods disordersmaternity complicationsbehavioral symptomsmaternitymaternal distressmental healthpostnatal depressionsocial healthprimary care

Outcome Measures

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

    Through study completion, an average of 10 months

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Porte Verte

Versailles, Île-de-France Region, 78000, France

RECRUITING

Related Publications (9)

  • 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.

    PMID: 24844913BACKGROUND
  • 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.

    PMID: 31035856BACKGROUND
  • 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.

    PMID: 25455250BACKGROUND
  • Depression and Suicide Screening Gregory Plemmons MD, MFA, in Adolescent Health Screening: an Update in the Age of Big Data, 2019

    BACKGROUND
  • Référentiel de psychiatrie. Collège national des universitaires en psychiatrie. Presses universitaires François Rabelais, 3ème édition, 2021

    BACKGROUND
  • 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.

    PMID: 14583691BACKGROUND
  • 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.

    PMID: 3651732BACKGROUND
  • 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.

    PMID: 19698604BACKGROUND
  • 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.

    PMID: 2224383BACKGROUND

Related Links

MeSH Terms

Conditions

Depression, PostpartumDepressive DisorderMental DisordersPregnancy ComplicationsPuerperal DisordersBehavioral SymptomsPsychological Well-Being

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMood DisordersBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Cyriane COURTOIS-B, DR

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 21, 2023

Study Start

September 30, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations