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

Primary Purpose

Delivery, Post Partum

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
patient questionnaire and telephone follow-up
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Delivery focused on measuring Posttraumatic stress disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UH Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnosis and follow-up arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Detect a state of post-traumatic stress
Using the PCL-S scale at 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

Full Information

First Posted
November 5, 2019
Last Updated
November 8, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04160273
Brief Title
Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)
Acronym
ESPT-PP
Official Title
Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery, Post Partum
Keywords
Posttraumatic stress disorder

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnosis and follow-up arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
patient questionnaire and telephone follow-up
Intervention Description
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
Primary Outcome Measure Information:
Title
The risk of PTSD at 1 month is detected using the PCL-S scale.
Description
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.
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Determine the emotional distress of a person at the time of a traumatic event at 1 month and one year
Description
Using the immediate postpartum PDI scale at 1 month and one year
Time Frame
1 month and 1year
Title
Detect a state of post-traumatic stress
Description
Using the PCL-S scale at 1 month and 1 year
Time Frame
1 Month and 1 year
Title
Collect the risk factors associated with PTSD
Description
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
Time Frame
5 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume LEGENDRE, MDPhD
Phone
33-(0)2-41-35-44-59
Email
guillaume.legendre@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Blanchet, MD
Email
sofiblanchet@hotmail.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume LEGENDRE, MDPhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume LEGENDRE, MDPhD
Email
guillaume.legendre@chu-angers.fr

12. IPD Sharing Statement

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

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