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Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression (COVIDDEPERINAT)

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ClinicalTrials.gov Identifier: NCT04516668
Recruitment Status : Not yet recruiting
First Posted : August 18, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.

Condition or disease
Post Partum Depression

Detailed Description:

The pandemic of COVID-19 (coronavirus desease 19) led to a strict quarantine from 15 March 2020 to 11 May 2020. Maternal depression is a current pathology , especially in the post-partum (more than 15%). The quarantine could lead to anxious and/or depressive symptoms and difficulties in parents-children bonding.

Women who have experenced post-partum period have more chance to developp subsequent depression.

Among women who have experienced post-partum depression, those who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Evaluation of Hospital anxiety and depression scale (HAD) [ Time Frame: 15 minutes ]

    To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation

    Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case



Secondary Outcome Measures :
  1. Evaluation of Edinburgh Postpartum Depression Scale (EPDS) [ Time Frame: 15 minutes ]
    To compare the result of EPDS in women who have a child of less 2 years old according to a follow-up or not by tele-consultation during the quarantine

  2. Evaluation of HAD score in fathers [ Time Frame: 15 minutes ]
    Anxiety and depression of fathers will be assessed with HAD scale

  3. Evaluation of EPDS in fathers [ Time Frame: 15 minutes ]
    EPDS will be assessed in fathers who have a child of less than 2 years old

  4. Study of the relationship between maternals and paternals symptoms [ Time Frame: 15 minutes ]
    The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptoms

  5. Study of difficuties in child during the quarantine [ Time Frame: 15 minutes ]
    Look for a correlation between the difficulties in child during the quarantine describe by parents and anxiety and depression symptoms in parents The difficulties in child will be illustrated with the rate of children with difficulties describe by the parents

  6. Risk and protection factors [ Time Frame: 15 minutes ]
    Description of risk factors and protection factors setting up by the family during this quarantine period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who were treated by the psychiatry department at Bicêtre hospital for post-partum depression between 2013 and late 2019 and their partner
Criteria

Inclusion Criteria:

Women above 18 years old

Who have experienced a post-partum depression between 2013 and late of 2019

Who have benefit a psychiatry post-partum follow-up (hospitalizations in psychiatry post-partum unity and/or medical consultation) by Bicêtre psychiatry service

Who have a child less than 7 years old (preschool age)

Speaking and reading in french

And their partner (above 18 years old)

In the main analyze, only women with a indication of following psychiatric follow-up by tele-consultation (with a psychiatric follow-up at the begenning of the quarantine, who have not been follow-up by psychiatrist in hospitalization or in face to face consultation) will be analyzed

Exclusion Criteria:

People with chronic psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders:DSM-5 criteria)

People with mental handicap

People who are not able to give their consent

People subject to protection measure

People refusing to participate in the study


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): NCT04516668


Contacts
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Contact: Florence Gressier, Dr 01 45 21 27 43 florence.gressier@aphp.fr
Contact: Emmanuelle Corruble, Pr 01 45 21 27 43 emmanuelle.corruble@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Florence Gressier, Dr Bicêtre Hospital
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04516668    
Other Study ID Numbers: APHP200878
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: July 2020

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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 Assistance Publique - Hôpitaux de Paris:
Post Partum Depression
Tele-consultation
COVID-19
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications