Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03344471 |
| Other study ID # |
PO17133 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2017 |
| Est. completion date |
December 14, 2019 |
Study information
| Verified date |
February 2022 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 ΒΌ 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.
