NCT03088319

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2019

Completed
Last Updated

February 12, 2020

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

March 11, 2017

Last Update Submit

February 10, 2020

Conditions

Keywords

postnatal depression stress mindfulness allostatic load

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

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

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

Locations