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

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.

Study Overview

• Status: Unknown
• Conditions: Post Partum; Delivery
• Intervention / Treatment: Diagnostic test: patient questionnaire and telephone follow-up

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume LEGENDRE, MDPhD; Phone Number: 33-(0)2-41-35-44-59; Email: guillaume.legendre@chu-angers.fr
• Study Contact Backup: Name: Sophie Blanchet, MD; Email: sofiblanchet@hotmail.fr

Study Locations

• France
  • Angers, France, 49933
    • UH Angers
    • Contact: Guillaume LEGENDRE, MDPhD; Email: guillaume.legendre@chu-angers.fr

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnosis and follow-up arm; Patients are informed during the 9th month pregnancy consultation consultation at Angers University Hospital by the midwife or obstetrician in charge of the consultation. They are included in the 48 hours following the delivery after their hospitalization in the maternity ward. During hospitalization, socio-demographic and medical data are collected and the IDP scale is completed before returning home. Follow-up at one month and one year is carried out by the investigators by means of a telephone call during which the patient answers the PCL-S questionnaire. Also collected during this call are information on the physical and mental state of the patient, the state of health of her newborn and the progress of the return home. Patients are considered at high risk of PTSD if they have a PCL-S score ≥ 44 at 1 month. 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Detect a state of post-traumatic stress	Using the PCL-S scale at 1 month and 1 year	1 Month and 1 year
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Guillaume LEGENDRE, MDPhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Posttraumatic stress disorder
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2019-A02369-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No