Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery
PTSD-preterm
1 other identifier
interventional
48
1 country
1
Brief Summary
Each year in France, between 50,000 and 60,000 children are born prematurely (\< 37 weeks of amenorrhea). Literature has shown that preterm deliveries can be associated with the development of PTSD (Post-Traumatic Stress Disorder) in mothers. Around ¼ of women suffer from a PTSD after giving birth prematurely. Moreover, studies highlighted the consequences of a PTSD on the child-mother relationship. Beyond the importance of early detection, it could be important to predict factors that make women more likely to develop a PTSD. This study will focus on personal factors (5 dimensions of personality). Our hypothesis is that personality traits are associated with the likeliness of developing a PTSD after a preterm delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Typical duration for not_applicable
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
November 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2019
CompletedFebruary 18, 2022
February 1, 2022
1.4 years
November 14, 2017
February 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PPQ (Perinatal PTSD Questionnaire)
The PPQ is widely used to assess symptoms of PTSD after preterm delivery.
Day 0
NEO-FFI
self-administered questionnaire used to measure 5 dimensions of personality (Neuroticism, Extraversion, Openness, Agreeability and Conscientiousness)
Day 0
Study Arms (2)
women with PTSD after preterm deliver
OTHERwomen without PTSD after preterm deliver
OTHERInterventions
Specific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality)
Eligibility Criteria
You may qualify if:
- mothers who have given birth prematurely (\<33 weeks of amenorrhea)
- mothers who speak French fluently
- mothers consenting to participate to the study
- mothers enrolled in the national healthcare insurance program
- mothers older than 18 years
You may not qualify if:
- mothers with acute or chronic psychotic disorders,
- mothers with alcohol and/or drug abuse or dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Damien JOLLY
Reims, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 17, 2017
Study Start
December 13, 2017
Primary Completion
May 14, 2019
Study Completion
December 14, 2019
Last Updated
February 18, 2022
Record last verified: 2022-02