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NCT Number: NCT07200323

Prevalence of Postpartum Depression Among Patients of the CHUM GARE Clinic

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.

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Key information

Conditions

Post-partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Maternal Health Mental Disorders Mental Health Issue Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

About this study

Postpartum depression (PPD) is a common complication in the weeks following childbirth, with potential consequences for maternal health and early infant development. Although validated tools such as the Edinburgh Postnatal Depression Scale (EPDS) exist, systematic screening is not uniformly integrated into routine postpartum care. This prospective observational study aims to evaluate the implementation of a structured protocol for the identification and referral of postpartum depression in a high-risk obstetric population.

The study will include 100 postpartum patients followed at the high-risk pregnancy clinic of the CHUM. All participants will be systematically screened for symptoms of postpartum depression using the EPDS during their scheduled postpartum visit. For patients with a score of 13 or higher, medical orientation will be guided by a standardized clinical algorithm that defines the recommended follow-up. Two follow-up telephone calls will be conducted, at two weeks and six weeks after the initial screening, to confirm whether the recommended referrals have been completed and to evaluate the time required to access appropriate services.

The primary objective of the study is to estimate the prevalence of postpartum depression in this population. The secondary objective is to assess the feasibility of implementing a systematic screening protocol combined with a clinical algorithm to guide referral and follow-up. The study also seeks to explore clinical characteristics associated with elevated EPDS scores, including age, level of education, lifestyle habits (smoking, alcohol or drug consumption), psychiatric, medical and obstetric history (including history of miscarriage), mode of delivery and method of perinatal analgesia, breastfeeding, iron-deficiency anemia or iron deficiency, obstetric, anesthetic, or neonatal complications and skin-to-skin contact in the delivery room within the first 24 hours after birth.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Prevalence of postpartum depression in the study population

    Time frame: Baseline EPDS score (Day 0)

    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.

Secondary outcomes

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

    Time frame: Immediately after EPDS completion

    Categorical outcome measuring the type of referral initiated following EPDS screening (e.g., pamphlet of information, primary care health services, psychiatrist, primary care physician, emergency department).

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

    Time frame: 2 weeks after initial EPDS score

    EPDS score collected by telephone at 2 weeks for patients with a Day 0 score between 13 and 16. Outcome measured as the proportion of patients whose score remains ≥13. The Edimburgh Postnatal Depression Scale (EPDS) is a validated 10-item questionnaire designed to identify symptoms of depression in postnatal mothers.

  3. Number of days before the first contact with referred service

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

    Number of days between the initial referral (Day 0) and confirmed access to the referred service (by patient report).

  4. Clinical and obstetrical factors associated with EPDS ≥13

    Time frame: Chart review conducted following Day 0 visit and consent

    Exploratory analysis to evaluate associations between an elevated EPDS score (≥13) and selected clinical variables, including age, level of education, lifestyle habits (smoking, alcohol or drug consumption), psychiatric, medical and obstetric history (including history of miscarriage), mode of delivery and method of perinatal analgesia, breastfeeding, iron-deficiency anemia or iron deficiency, obstetric, anesthetic, or neonatal complications, and skin-to-skin contact in the delivery room within the first 24 hours after birth.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: PPD-GARE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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