Post-natal Depression and Chronic Stress
serene
Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2019
CompletedFebruary 12, 2020
August 1, 2018
2.5 years
March 11, 2017
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index
baseline at three 3 months of pregnancy and two months after labour delivery
Other Outcomes (1)
psychological functioning as a composite index including well-being, and stress control
baseline at three 3 months of pregnancy and two months after labour delivery
Eligibility Criteria
WOMEN DURING EARLY PREGNANCY
You may qualify if:
- Physiological pregnancy
- Follow-up of pregnancy in a participating maternity
- Female over 18 years
- Affiliated to a social security scheme
You may not qualify if:
- Multiple pregnancy
- Psychiatric, neurological, or endocrine or autoimmune diseases
- Hormonal or psychotropic treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marion Trousselard
Brétigny-sur-Orge, Not in US/Canada, 91223, France
Related Publications (1)
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.
PMID: 29724735DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior researcher
Study Record Dates
First Submitted
March 11, 2017
First Posted
March 23, 2017
Study Start
April 11, 2017
Primary Completion
October 11, 2019
Study Completion
October 11, 2019
Last Updated
February 12, 2020
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share