- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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post natal depression
Tidsram: 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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
psychological functioning as a composite index including well-being, and stress control
Tidsram: baseline at three 3 months of pregnancy and two months after labour delivery
|
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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2016-A00887-44
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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