- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03088319
Post-natal Depression and Chronic Stress (serene)
Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
The risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The PND appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.
This study aim to follow a cohort of pregnant women to determine the predictive psychobiological factors of the emergence of postnatal depression
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The prevalence of postnatal depression is high in civilian settings (20%). In mechanistic terms, the risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The post natal depression appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.
- On the one hand, the repetition of stressors during pregnancy corresponds to a natural chronic stress model of several months and thus allows to study the biological cost of responses to repeated stresses, and the adaptive mechanisms leading to From functional drift to psychic dysfunction.
- On the other hand, isolated vulnerability factors characterize a mirroring psychological profile of a Mindfulness type of functioning. Mindfulness or full consciousness has been described as a state of consciousness which results from intentionally, at the present moment, without judging the experience that unfolds moment by moment. This psychological resource has been associated with resilient or even resilient psychic functioning.
This study aim to follow a cohort of pregnant women from the first trimester of pregnancies to 2 months after the delivery to determine the predictive psychobiological factors of the emergence of postnatal depression
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Not In US/Canada
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Brétigny-sur-Orge, Not In US/Canada, Frankrike, 91223
- Marion Trousselard
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Physiological pregnancy
- Follow-up of pregnancy in a participating maternity
- Female over 18 years
- Affiliated to a social security scheme
Exclusion Criteria:
- Multiple pregnancy
- Psychiatric, neurological, or endocrine or autoimmune diseases
- Hormonal or psychotropic treatments
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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post natal depression
Tidsramme: baseline at three 3 months of pregnancy and two months after labour delivery
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change in Edimbourg Post-Partum Depression scale at two months after labour delivery
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baseline at three 3 months of pregnancy and two months after labour delivery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index
Tidsramme: baseline at three 3 months of pregnancy and two months after labour delivery
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change in allostatic load two months after labour delivery
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baseline at three 3 months of pregnancy and two months after labour delivery
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
psychological functioning as a composite index including well-being, and stress control
Tidsramme: baseline at three 3 months of pregnancy and two months after labour delivery
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change in psychological functioning two months after labour delivery
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baseline at three 3 months of pregnancy and two months after labour delivery
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016-A00887-44
Plan for individuelle deltakerdata (IPD)
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