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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04368208
Other study ID # 2020-A01065-34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 29, 2020
Est. completion date November 27, 2020

Study information

Verified date April 2020
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 501
Est. completion date November 27, 2020
Est. primary completion date October 21, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
France Bertrand GACHON Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum 4-6 weeks postpartum
Secondary Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia 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 4-6 weeks postpartum
Secondary Describe the experience and the satisfaction about delivery during the covid 19 pandemia Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfaction within the week after delivery
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