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

NCT ID: NCT04160273

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2025-03-12

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.

Conditions

Delivery; Post Partum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

patient questionnaire and telephone follow-up

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume LEGENDRE, MDPhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

UH Angers

Angers, , France

Countries

France

Other Identifiers

2019-A02369-48

Identifier Type: -

Identifier Source: org_study_id