- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368208
Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression (DEPRECOVID)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Poitiers, France
- Bertrand GACHON
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia
Time Frame: 4-6 weeks postpartum
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proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum
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4-6 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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4-6 weeks postpartum
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Describe the experience and the satisfaction about delivery during the covid 19 pandemia
Time Frame: within the week after delivery
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Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfaction
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within the week after delivery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- COVID-19
- Depression, Postpartum
Other Study ID Numbers
- 2020-A01065-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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