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Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression (DEPRECOVID)

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: NCT04368208
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health.

The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression.

It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.


Condition or disease Intervention/treatment
Postnatal Depression Other: Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : October 29, 2020
Estimated Study Completion Date : December 14, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery
    The Edinburgh questionnaire is a self questionnaire validated for postnatal depression between 4 and 6 weeks postnatal
    Other Names:
    • Assessment of satisfaction about childbirth using the WOMBLSQ4 questionnaire within the week after delivery
    • Retrospective assessment of prenatal anxiety within the week after the delivery
    • Assessment of pelvic floor disorders using the PFDI questionnaire between 4 and 6 weeks after delivery
    • Assessment of self rated health for the woman and the child using the WHO question about self rated health between 4 and 6 weeks after delivery


Primary Outcome Measures :
  1. Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia [ Time Frame: 4-6 weeks postpartum ]
    proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum


Secondary Outcome Measures :
  1. Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia [ Time Frame: 4-6 weeks postpartum ]
    Existence of an association with postnatal depression and these factors: socio demographic women's characteristics, modalities of pregnancy management, satisfaction and experience about delivery, postnatal pelvic floor disorders, self rated health for the woman and the child, modalities of delivery, prenatal anxiety

  2. Describe the experience and the satisfaction about delivery during the covid 19 pandemia [ Time Frame: within the week after delivery ]
    Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfaction



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population

Women who deliver of a single baby, at term and in cephalic presentation whatever is the modalities of delivery (instrumental, cesarean, spontaneous delivery) will be included after their delivery.

Premature and non cephalic birth will be excluded because they are specific deliveries that may be assoictaed with a specific maternal anxietey. Women with psychiatric disorders are excluded since we investigated the occurrence of postnatal depression which is a psychiatric disorder.

Women without any internet access are excluded because women will have to fill online questionnaires. Finally women will be informed, as well as their doctors, in case of postnatal depression with an advice of planning a medical consultation.

Criteria

Inclusion Criteria:

  • women older than 18 years
  • women who deliver of a singleton, term neonate in cephalic presentation

Exclusion Criteria:

  • women younger than 18 years
  • women who deliver of a baby in non cephalic presentation
  • women with pre term Birth
  • women without any internet access
  • women with psychiatric disorders
  • women who do not understand french language
  • women who refuse to be aware of the results of the postnatal depression screening and who refuse that her doctor be ware of the results

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): NCT04368208


Contacts
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Contact: Bertrand GACHON, MD, PhD student 0549444444 bertrand.gachon@chu-poitiers.fr

Locations
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France
Bertrand GACHON Recruiting
Poitiers, France
Sponsors and Collaborators
Poitiers University Hospital
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04368208    
Other Study ID Numbers: 2020-A01065-34
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: April 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 Poitiers University Hospital:
childbirth
covid 19
satisfaction
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications