Back to resultsScreening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic (COVIE-19/20)
Primary Purpose
Postpartum Depression, Covid19, Prevalence
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional other trial for Postpartum Depression focused on measuring Postpartum Depression, Covid19, Prevalence, Social Distance
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
Variation of prevalence of clinically-significant post-partum depressive symptoms
Variation of prevalence of clinically-significant post-partum depressive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT04487171
First Posted
July 24, 2020
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier de Beauvais, Central Hospital Saint Quentin, Centre Hospitalier Compiègne
1. Study Identification
Unique Protocol Identification Number
NCT04487171
Brief Title
Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
Acronym
COVIE-19/20
Official Title
Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier de Beauvais, Central Hospital Saint Quentin, Centre Hospitalier Compiègne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Covid19, Prevalence, Social Distance
Keywords
Postpartum Depression, Covid19, Prevalence, Social Distance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
The mothers were administrated three questionnaires, (i) the Edinburgh Postnatal Depression Scale (EPDS), (ii) the State-Trait Anxiety Inventory (STAI-YA), and (iii) the Mother-to-Infant Bonding Scale (MIBS) in two stages, on days 2-3 after delivery and during a phone call between days 25-35.
Primary Outcome Measure Information:
Title
Variation of prevalence of clinically-significant post-partum depressive symptoms
Description
Variation of prevalence of clinically-significant post-partum depressive symptoms
Time Frame
up to 35 days after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women who deliver
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur FOULON, MD
Phone
(33)322087382
Email
foulon.arthur@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier BENAROUS, MD
Phone
(33)322087630
Email
benarous.xavier@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur FOULON, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Foulon, MD
Phone
(33)322087382
Email
foulon.arthur@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
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