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Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery (PTSD-preterm)

Primary Purpose

Preterm Delivery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Passation of questionnaires
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Preterm Delivery focused on measuring preterm delivery, PTSD, prematurity, birth, personality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • mothers with acute or chronic psychotic disorders,
  • mothers with alcohol and/or drug abuse or dependence

Sites / Locations

  • Damien JOLLY

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

women with PTSD after preterm deliver

women without PTSD after preterm deliver

Arm Description

Outcomes

Primary Outcome Measures

PPQ (Perinatal PTSD Questionnaire)
The PPQ is widely used to assess symptoms of PTSD after preterm delivery.
NEO-FFI
self-administered questionnaire used to measure 5 dimensions of personality (Neuroticism, Extraversion, Openness, Agreeability and Conscientiousness)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2017
Last Updated
February 17, 2022
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT03344471
Brief Title
Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery
Acronym
PTSD-preterm
Official Title
Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
PTSD : Post-Traumatic Stress Disorder. This syndrome can be found in people after they experience a traumatic event. Literature has shown that preterm delivery can lead to the development of PTSD in mothers. PTSD is characterized by symptoms such as: Re-experiencing the trauma through intrusive distressing recollections of the event, flashbacks, and nightmares. Emotional numbness and avoidance of places, people, and activities that are reminders of the trauma. Increased arousal such as difficulty sleeping and concentrating, feeling jumpy, and being easily irritated and angered. Each year in France, between 50,000 and 60,000 children are born prematurely (< 37 weeks of amenorrhea). Literature has shown that preterm deliveries are 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. ) In order to test our hypothesis, we will have two groups: (1) women who gave birth prematurely and developed a PTSD and (2) women who gave birth prematurely and did not develop a PTSD. Mothers will be recruited in the hospital of Reims a month after delivery. If they accept to participate in the study, a face-to-face-1-hour appointment will be scheduled. During this appointment, women of both groups will take a PTSD questionnaire (the PPQ - Perinatal PTSD Questionnaire) as well as a personality test (the NEO-FFI, see outcome measures) to assess 5 dimensions of their personality (Neuroticism, Extraversion, Openness, Agreeability and Conscientiousness). Individual data will also be collected such as the age of the mother, baby's birth weight, severity of prematurity. Statistical analyzes will be performed to analyze our results. Student t will be used to compare factors associated with PTSD between both groups. Correlation tests (such as Bravais-Pearson) will also be used to highlight links between personality dimensions and the likeliness to develop a PTSD after a preterm delivery. NB: Although no intervention is planned in this research, every woman getting a positive score in the PPQ will be addressed to the department's psychologist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery
Keywords
preterm delivery, PTSD, prematurity, birth, personality

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
women with PTSD after preterm deliver
Arm Type
Other
Arm Title
women without PTSD after preterm deliver
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Passation of questionnaires
Intervention Description
Specific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality)
Primary Outcome Measure Information:
Title
PPQ (Perinatal PTSD Questionnaire)
Description
The PPQ is widely used to assess symptoms of PTSD after preterm delivery.
Time Frame
Day 0
Title
NEO-FFI
Description
self-administered questionnaire used to measure 5 dimensions of personality (Neuroticism, Extraversion, Openness, Agreeability and Conscientiousness)
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: mothers with acute or chronic psychotic disorders, mothers with alcohol and/or drug abuse or dependence
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France

12. IPD Sharing Statement

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Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery

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