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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03088319
Other study ID # 2016-A00887-44
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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