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Post-natal Depression and Chronic Stress (serene)

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ClinicalTrials.gov Identifier: NCT03088319
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Marion Trousselard, Institut de Recherche Biomedicale des Armees

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


Condition or disease
Depression, Postpartum

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


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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : October 11, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. post natal depression [ Time Frame: baseline at three 3 months of pregnancy and two months after labour delivery ]
    change in Edimbourg Post-Partum Depression scale at two months after labour delivery


Secondary Outcome Measures :
  1. allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index [ Time Frame: baseline at three 3 months of pregnancy and two months after labour delivery ]
    change in allostatic load two months after labour delivery


Other Outcome Measures:
  1. psychological functioning as a composite index including well-being, and stress control [ Time Frame: baseline at three 3 months of pregnancy and two months after labour delivery ]
    change in psychological functioning two months after labour delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
WOMEN DURING EARLY PREGNANCY
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088319


Contacts
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Contact: catherine verret, PHD MD 00 33 1 65 78 12 55 catherine.verret@intradef.gouv.fr

Locations
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France
Marion Trousselard Recruiting
Brétigny-sur-Orge, Not In US/Canada, France, 91223
Contact: marion trousselard    0603771727    marion.trousselard@gmail.com   
Sponsors and Collaborators
Institut de Recherche Biomedicale des Armees

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marion Trousselard, senior researcher, Institut de Recherche Biomedicale des Armees
ClinicalTrials.gov Identifier: NCT03088319     History of Changes
Other Study ID Numbers: 2016-A00887-44
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marion Trousselard, Institut de Recherche Biomedicale des Armees:
postnatal depression stress mindfulness allostatic load
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications