DeliveryESPT-PPNCT04160273
Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)
A study testing patient questionnaire and telephone follow-up in people with Delivery and Post Partum, run by University Hospital, Angers at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery, Post Partum
- What is being tested?
- patient questionnaire and telephone follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,451 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2021to 12 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Delivery, Post Partum
- Being tested
- patient questionnaire and telephone follow-up
- Keywords
- Posttraumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient questionnaire and telephone follow-upDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: patient questionnaire and telephone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Using the immediate postpartum PDI scale at 1 month and one year
Measured: 1 month and 1year
Detect a state of post-traumatic stress
Using the PCL-S scale at 1 month and 1 year
Measured: 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
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start5 Mar 2021
- Primary completion5 Mar 2024
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliveryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume LEGENDRE, MDPhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160273
- Sponsor's protocol ID
- 2019-A02369-48
- Acronym
- ESPT-PP
- Status last verified
- Jul 2025
- First submitted
- 5 Nov 2019
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)
- ClinicalTrials.gov ID
- NCT04160273
- Acronym / sponsor ID
- ESPT-PP / 2019-A02369-48
- Conditions
- Delivery, Post Partum
- Keywords
- Posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,451 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis and follow-up arm | Experimental | Diagnostic Test: patient questionnaire and telephone follow-upPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient questionnaire and telephone follow-upPDI 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 | Diagnostic test | Diagnosis and follow-up arm |
Primary outcome
The risk of PTSD at 1 month is detected using the PCL-S scale.
Time frame: 1 Month
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.
3 secondary outcomes
Determine the emotional distress of a person at the time of a traumatic event at 1 month and one year
Time frame: 1 month and 1year
Detect a state of post-traumatic stress
Time frame: 1 Month and 1 year
Collect the risk factors associated with PTSD
Time frame: 5 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume LEGENDRE, MDPhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient questionnaire and telephone follow-up in people with Delivery and Post Partum, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The risk of PTSD at 1 month is detected using the PCL-S scale. (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.