Post-partum DepressionPPD-GARENCT07200323
Prevalence of Postpartum Depression Among Patients of the CHUM GARE Clinic
An observational study of Post-partum Depression and Maternal Health, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-partum Depression, Maternal Health, Mental Health Issue
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Inability to comprehend and/or complete the EPDS
- Declines participation or does not provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
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.
Read the detailed description
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.
- Conditions
- Post-partum Depression, Maternal Health, Mental Health Issue
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline EPDS score (Day 0)
Secondary outcomes (4)
Orientation to a medical or psychosocial resource based on EPDS score and decision algorithm
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).
Measured: Immediately after EPDS completion
Repeat EPDS score at 2-week follow-up (for scores between 13 and 16 only)
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.
Measured: 2 weeks after initial EPDS score
Number of days before the first contact with referred service
Number of days between the initial referral (Day 0) and confirmed access to the referred service (by patient report).
Measured: Assessed at two-week and, if needed, six-week follow-up calls
Clinical and obstetrical factors associated with EPDS ≥13
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.
Measured: Chart review conducted following Day 0 visit and consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start20 Oct 2025
- Primary completion18 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-partum DepressionStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Lavoie, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200323
- Sponsor's protocol ID
- 2026-13020
- Acronym
- PPD-GARE
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Postpartum Depression Among Patients of the CHUM GARE Clinic
- ClinicalTrials.gov ID
- NCT07200323
- Acronym / sponsor ID
- PPD-GARE / 2026-13020
- Conditions
- Post-partum Depression, Maternal Health, Mental Health Issue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to comprehend and/or complete the EPDS
- Declines participation or does not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Orientation to a medical or psychosocial resource based on EPDS score and decision algorithm
Time frame: Immediately after EPDS completion
Repeat EPDS score at 2-week follow-up (for scores between 13 and 16 only)
Time frame: 2 weeks after initial EPDS score
Number of days before the first contact with referred service
Time frame: Assessed at two-week and, if needed, six-week follow-up calls
Clinical and obstetrical factors associated with EPDS ≥13
Time frame: Chart review conducted following Day 0 visit and consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Lavoie, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-partum Depression and Maternal Health, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of postpartum depression in the study population (time frame: Baseline EPDS score (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.