Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)

Delivery Clinical Trial

— ESPT-PP  

Official title:

Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04160273
• Other study ID #: 2019-A02369-48
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: November 2020

Study information

• Verified date: November 2019
• Source: University Hospital, Angers
• Contact: Guillaume LEGENDRE, MDPhD
• Phone: 33-(0)2-41-35-44-59
• Email: guillaume.legendre[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to estimate the prevalence of post-traumatic stress disorder (PTSD) at one month in women who have given birth at the University Hospital of Angers over a period of 1 year.

Description:

Childbirth is a natural process expected, prepared and imagined by all future parents.

A traumatic experience of childbirth and its consequences is a major problem that is often underestimated for women's health. Some women may develop Post Traumatic Stress Disorder (PTSD) after delivery. The literature reports a prevalence of PTSD in relation to childbirth of 1.3 to 6%.

Symptoms of post-traumatic stress can be triggered by any event, perceived as threatening to the life or physical integrity of the person or a third party and causing intense fear, helplessness and horror.

It may be thought that childbirth, by its psychological and physiological characteristics, can be described as an extreme experience and its experience depends on multiple factors. Thus, an innocent childbirth for caregivers can be traumatically experienced by the woman.

The symptoms described are symptoms of avoidance (inability to return to the scene of trauma, denial of trauma), symptoms of intrusion (nightmares, reviviscences) and symptoms of neuro-vegetative hyper activation (sleep disorders, anger, emotional indifference ).

The development of PTSD following childbirth is a known phenomenon, but minimized and very little diagnosed by obstetric teams.

Therefore, it seems interesting to assess the prevalence of PTSD during childbirth in order to optimize our management, that is to identify patients at risk of PTSD and offer them adapted psychological follow-up.

This study also aims to describe the kinetics of the development of post-traumatic postpartum symptoms and to study the risk factors for the development of PTSD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major and francophone patient,

• Giving birth (= 37 weeks of amenorrhea) to the maternity hospital of Angers University Hospital,

• Agree to participate in the study (signature of consent).

Exclusion Criteria:

• Personal antecedent (s) of psychiatric pathology (s),

• Birth of a child born lifeless,

• Patient deprived of liberty by judicial or administrative decision,

• Patient subject to a legal protection measure,

• Patient unable to express her consent.

Related Conditions & MeSH terms

• Delivery
• Post Partum
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Diagnostic Test:
• patient questionnaire and telephone follow-up
PDI scale is filled in before returning home and follow-up at one month and one year thanks to a telephone call during which the patient answers the PCL-S questionnaire

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The risk of PTSD at 1 month is detected using the PCL-S scale.	The risk of PTSD at 1 month is detected using the PCL-S scale. Patients are considered at high risk if they have a score = 44 on this scale. A consultation with a psychiatrist is offered to these patients at risk of PTSD in order to make the diagnosis and offer them appropriate care if necessary.	1 Month
Secondary	Determine the emotional distress of a person at the time of a traumatic event at 1 month and one year	Using the immediate postpartum PDI scale at 1 month and one year	1 month and 1year
Secondary	Detect a state of post-traumatic stress	Using the PCL-S scale at 1 month and 1 year	1 Month and 1 year
Secondary	Collect the risk factors associated with PTSD	The risk factors studied are as follows: socio-economic status, gestational-parity, obstetrical history, psycho-pathological antecedents, addictions , current pregnancy course, term childbirth, mode of delivery and its complications, course of the hospitalization	5 Days