- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487171
Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic (COVIE-19/20)
March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Postpartum depression (PPD) represent around 15% of birth in developed countries.
The context of the COVID-19 epidemy represents a possible source of additional emotional distress.
The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
248
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arthur Foulon, MD
- Phone Number: (33)322087382
- Email: foulon.arthur@chu-amiens.fr
Study Contact Backup
- Name: Xavier BENAROUS, MD
- Phone Number: (33)322087630
- Email: benarous.xavier@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80480
- Recruiting
- CHU Amiens
-
Contact:
- Arthur Foulon, MD
- Phone Number: (33)322087382
- Email: foulon.arthur@chu-amiens.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Single baby delivery
- alive new born child without admission in neonatal intensive care unit
- French-speaking mother
- mother older than 18 years old
Exclusion Criteria:
- Patients who refuses the inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variation of prevalence of clinically-significant post-partum depressive symptoms
Time Frame: up to 35 days after delivery
|
Variation of prevalence of clinically-significant post-partum depressive symptoms
|
up to 35 days after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Arthur FOULON, MD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2020
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
July 24, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- COVID-19
- Depression, Postpartum
Other Study ID Numbers
- PI2020_843_0049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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