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CompletedNCT04160273ESPT-PPUpdated Jul 25, 2025

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

An interventional study of patient questionnaire and telephone follow-up in Delivery and Post Partum, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
1,451
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Delivery
  • Post Partum

Keywords

  • Posttraumatic stress disorder
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 1,451 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,451 participants (actual)

Study arms

  • Experimental
    Diagnosis and follow-up arm

    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

  • Diagnostic testpatient 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

06

What researchers measure

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.

    Time frame: 1 Month

Secondary outcomes

  1. 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

    Time frame: 1 month and 1year

  2. Detect a state of post-traumatic stress

    Using the PCL-S scale at 1 month and 1 year

    Time frame: 1 Month and 1 year

  3. 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

    Time frame: 5 Days

07

Study locations

1 site
  • UH Angers
    Angers, 49933, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04160273
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Nov 12, 2019
Start date
Mar 5, 2021
Primary completion
Mar 5, 2024
Completion
Mar 12, 2025
Last update
Jul 25, 2025

Study contacts

Guillaume LEGENDRE, MDPhD
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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