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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Delivery
• Intervention / Treatment: Other: Passation of questionnaires

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Damien JOLLY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: women with PTSD after preterm deliver	Other: Passation of questionnaires; Specific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality)
Other: women without PTSD after preterm deliver	Other: Passation of questionnaires; Specific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): December 14, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: PTSD; preterm delivery; prematurity; birth; personality
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Premature Birth
• Other Study ID Numbers: PO17133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No