Post-natal Depression and Chronic Stress

Depression, Postpartum Clinical Trial

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Official title:

Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088319
• Other study ID #: 2016-A00887-44
• Status: Completed
• Start date: April 11, 2017
• Est. completion date: October 11, 2019

Study information

• Verified date: August 2018
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Locations

Country	Name	City	State
France	Marion Trousselard	Brétigny-sur-Orge	Not In US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	psychological functioning as a composite index including well-being, and stress control	change in psychological functioning two months after labour delivery	baseline at three 3 months of pregnancy and two months after labour delivery
Primary	post natal depression	change in Edimbourg Post-Partum Depression scale at two months after labour delivery	baseline at three 3 months of pregnancy and two months after labour delivery
Secondary	allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index	change in allostatic load two months after labour delivery	baseline at three 3 months of pregnancy and two months after labour delivery