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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487171
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
Sponsor:
Collaborators:
Centre Hospitaler Beauvais
Central Hospital Saint Quentin
Centre Hospitalier Compiègne
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Covid19 Prevalence Social Distance Other: Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Questionnaire
    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 Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women who deliver
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487171


Contacts
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Contact: Arthur FOULON, MD (33)322087382 foulon.arthur@chu-amiens.fr
Contact: Xavier BENAROUS, MD (33)322087630 benarous.xavier@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Arthur Foulon, MD    (33)322087382    foulon.arthur@chu-amiens.fr   
Contact: MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Centre Hospitaler Beauvais
Central Hospital Saint Quentin
Centre Hospitalier Compiègne
Investigators
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Principal Investigator: Arthur FOULON, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04487171    
Other Study ID Numbers: PI2020_843_0049
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Postpartum Depression
Covid19
Prevalence
Social Distance
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications