NCT07200323

Brief Summary

Postpartum depression (PPD) is a frequent complication of the postnatal period but remains underdetected in routine clinical practice. This prospective clinical study, conducted at the high-risk pregnancy clinic of the CHUM, aims to estimate the prevalence of PPD among patients seen in postpartum follow-up. It also assesses the feasibility of implementing a standardized screening protocol that combines the administration of the Edinburgh Postnatal Depression Scale (EPDS) with a clinical decision-support algorithm to guide appropriate medical follow-up. The study also seeks to explore clinical characteristics associated with higher EPDS scores.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Oct 2025

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

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Study Timeline

Key milestones and dates

Study Progress46%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

September 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

October 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

September 15, 2025

Last Update Submit

February 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of postpartum depression in the study population

    Proportion of patients with an EPDS score ≥13 at the 4 to 8-week postpartum visit. The Edimburgh Postnatal Depression Scale (EPDS) is a validated 10-item questionnaire designed to identify symptoms of depression in postnatal mothers. Each question asks about feelings and experiences over the past seven days, covering various emotional and psychological aspects related to perinatal mood. For each question, there are four possible responses, scored from 0 to 3, with higher numbers indicating more severe symptoms. The total EPDS score indicates the severity of potential depressive symptoms: a score of 13 or above often suggests a high risk of developing a depressive disorder.

    Baseline EPDS score (Day 0)

Secondary Outcomes (4)

  • Orientation to a medical or psychosocial resource based on EPDS score and decision algorithm

    Immediately after EPDS completion

  • Repeat EPDS score at 2-week follow-up (for scores between 13 and 16 only)

    2 weeks after initial EPDS score

  • Number of days before the first contact with referred service

    Assessed at two-week and, if needed, six-week follow-up calls

  • Clinical and obstetrical factors associated with EPDS ≥13

    Chart review conducted following Day 0 visit and consent

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who gave birth within the last 4 weeks to 6 months at CHUM
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the high-risk pregnancy clinic (GARE - Grossesse à risque élevé) of the Centre hospitalier de l'Université de Montréal (CHUM) coming in for their post-partum visit with obstetrician

You may qualify if:

  • Patients aged 18 years or more
  • Patient who gave birth within the last 4 weeks to 6 months
  • Ability to understand French or English and complete the EPDS questionnaire
  • Physically present at their post-partum visit at the clinic

You may not qualify if:

  • Inability to comprehend and/or complete the EPDS
  • Declines participation or does not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Anne Lavoie, MD

    CHUM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2025

First Posted

October 1, 2025

Study Start

October 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations