Clinical trial NCT03088319: Post-natal Depression and Chronic Stress
Official title: Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Postpartum
Keywords: postnatal depression stress mindfulness allostatic load
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2017-03-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: WOMEN DURING EARLY PREGNANCY

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: post natal depression
timeFrame: baseline at three 3 months of pregnancy and two months after labour delivery
Secondary outcomes:
measure: allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index
timeFrame: baseline at three 3 months of pregnancy and two months after labour delivery
Other outcomes:
measure: psychological functioning as a composite index including well-being, and stress control
timeFrame: baseline at three 3 months of pregnancy and two months after labour delivery
Locations:
city: Brétigny-sur-Orge
country: France
facility: Marion Trousselard
state: Not In US/Canada
Study officials:
References:
citation: Tharwat D, Trousselard M, Bales M, Sutter-Dallay AL, Fromage D, Spitz E, Dallay D, Harvey T, Welter E, Coatleven F, Cherier L, Teissedre F, Pouly JL, Dutheil F, Duffaud AM. Chronic Stress protection for postnatal dEpREssioN prEvention (SERENE): a protocol for an exploratory study. BMJ Open. 2018 May 3;8(5):e018317. doi: 10.1136/bmjopen-2017-018317.