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

NCT04160273 | Completed

• 1 other identifier: 2019-A02369-48
• Study Type: interventional
• Target: 1,451
• Locations: 1 country
• Sites: 1

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.

Conditions

Delivery; Post Partum

Keywords

Posttraumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• 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 ≥ 26 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 Outcomes (3)

• Determine the emotional distress of a person at the time of a traumatic event at 1 month and one year

  1 month and 1year

• Detect a state of post-traumatic stress

  1 Month and 1 year

• Collect the risk factors associated with PTSD

  5 Days

Study Arms (1)

Diagnosis and follow-up arm

EXPERIMENTAL

Patients are informed during the 9th month pregnancy 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 Peritraumatic Distress Inventory, the peritraumatic dissociation questionnaire and the Edinburgh peritraumatic dissociation questionnaire are completed before returning home. Follow-up at 1 month and 1 year is carried out by the investigators and the patient answers to 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 ≥ 26 at 1 month. A consultation with a psychiatrist is offered to these patients at risk of PTSD.

Diagnostic Test: patient questionnaire and telephone follow-up

Interventions

patient questionnaire and telephone follow-up DIAGNOSTIC_TEST

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

Diagnosis and follow-up arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

UH Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Guillaume LEGENDRE, MDPhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 12, 2019
• Study Start: March 5, 2021
• Primary Completion: March 5, 2024
• Study Completion: March 12, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

FR (1)