Preterm DeliveryPTSD-pretermNCT03344471
Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery
A study testing Passation of questionnaires in people with Preterm Delivery, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- Passation of questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 14 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- mothers with acute or chronic psychotic disorders,
- mothers with alcohol and/or drug abuse or dependence
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Preterm Delivery
- Being tested
- Passation of questionnaires
- Keywords
- preterm delivery, PTSD, prematurity, birth, personality
- Medical subject headings
- Premature Birth, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passation of questionnairesOther
Specific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality)
| Study group | Role | What they receive |
|---|---|---|
| women with PTSD after preterm deliver | Other | Not described Receives: Other: Passation of questionnaires |
| women without PTSD after preterm deliver | Other | Not described Receives: Other: Passation of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPQ (Perinatal PTSD Questionnaire)
The PPQ is widely used to assess symptoms of PTSD after preterm delivery.
Measured: Day 0
NEO-FFI
self-administered questionnaire used to measure 5 dimensions of personality (Neuroticism, Extraversion, Openness, Agreeability and Conscientiousness)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Dec 2017
- Primary completion14 May 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344471
- Sponsor's protocol ID
- PO17133
- Acronym
- PTSD-preterm
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2017
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery
- ClinicalTrials.gov ID
- NCT03344471
- Acronym / sponsor ID
- PTSD-preterm / PO17133
- Conditions
- Preterm Delivery
- Keywords
- preterm delivery, PTSD, prematurity, birth, personality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with PTSD after preterm deliver | Other | Other: Passation of questionnaires |
| women without PTSD after preterm deliver | Other | Other: Passation of questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- mothers with acute or chronic psychotic disorders,
- mothers with alcohol and/or drug abuse or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passation of questionnairesSpecific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality) | Other | women with PTSD after preterm deliver, women without PTSD after preterm deliver |
Primary outcome
PPQ (Perinatal PTSD Questionnaire)
Time frame: Day 0
The PPQ is widely used to assess symptoms of PTSD after preterm delivery.
NEO-FFI
Time frame: Day 0
self-administered questionnaire used to measure 5 dimensions of personality (Neuroticism, Extraversion, Openness, Agreeability and Conscientiousness)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passation of questionnaires in people with Preterm Delivery, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPQ (Perinatal PTSD Questionnaire) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.