Pregnancy LossACTRAMAT-DNCT03433989
ACTRAMAT-D: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation
A study testing telephone interview in people with Pregnancy Loss, run by University Hospital, Angers at 1 site in France.
Trial summary
In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This situation is probably associated to a risk of post-traumatic stress disorder. As a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Loss
- What is being tested?
- telephone interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2018to 21 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- loss pregnancy after 12 weeks of gestation
- consent to participate in the clinical study
Who cannot join
- no french speaking
- psychiatric disease
- participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)
In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This situation is probably associated to a risk of post-traumatic stress disorder.
As a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term effects of a post-traumatic stress disorders.
The purpose of the present study is to estimate and analyze the prevalence of short-term (1 month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of gestation.The symptoms of post-traumatic stress disorder will be tracked using the Impact of Event Scale-revisited and the Peritraumatic Dissociative Experiences Questionnaires.The diagnosis of post-traumatic stress disorder will also be clinically confirmed by a psychiatrist during a specific consultation.
- Conditions
- Pregnancy Loss
- Being tested
- telephone interview
- Keywords
- Post-Traumatic Stress Disorder, Pregnancy loss
- 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.
telephone interviewDiagnostic test
questionnaire PDEQ et IES-R
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis and follow up arm | Experimental | Not described Receives: Diagnostic Test: telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of short-term post-traumatic stress disorder in women with fetal loss after 12 weeks of gestation with IES-R scale recorded at 30 days after fetal loss.
Assessment of the Impact of Events Scale-Revised (IES-R) score wil be performed by telephone interview by the principal investigator of the present study.
IES-R scale has been validated in 1997 (Weiss and Mar) and then validated in French in 2003 (Brunet and St Hilaire). This scale assesses the semi-retarded and retarded consequences of traumatic events. It consists in a 22 items questionnaire measuring symptoms of post-traumatic stress disorder (PTSD), just after traumatic event and after a while. It is based on three main PTSD's elements: avoidance symptoms (items 8, 11, 12, 13, 17, 22), intrusion symptoms (items 1, 3, 5, 6, 9, 16) and hyperarousal (items 2, 4, 10, 14, 15, 18, 21).The patient has to respond using Likert's scale.
score interpretations: 24-32: those with scores this high who do not have full PTSD will have partial PTSD. >33 this represents the best cutoff for a probable diagnosis of PTSD
Measured: Telephone interviews are planned 30 days after fetal loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start7 Mar 2018
- Primary completion21 Nov 2019
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy LossStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, prospective, epidemiological, descriptive and analytical study.
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- lucile Abiola, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433989
- Sponsor's protocol ID
- 2017-A02588-45
- Acronym
- ACTRAMAT-D
- Status last verified
- Dec 2019
- First submitted
- 12 Jan 2018
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abiola L, Legendre G, Spiers A, Parot-Schinkel E, Hamel JF, Duverger P, Bouet PE, Descamps P, Quelen C, Gillard P, Riquin E. Late fetal demise, a risk factor for post-traumatic stress disorder. Sci Rep. 2022 Jul 20;12(1):12364. doi: 10.1038/s41598-022-16683-5.
PubMed 35859001
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)
- ClinicalTrials.gov ID
- NCT03433989
- Acronym / sponsor ID
- ACTRAMAT-D / 2017-A02588-45
- Conditions
- Pregnancy Loss
- Keywords
- Post-Traumatic Stress Disorder, Pregnancy loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 15 Feb 2018 (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.
In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This situation is probably associated to a risk of post-traumatic stress disorder.
As a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term effects of a post-traumatic stress disorders.
The purpose of the present study is to estimate and analyze the prevalence of short-term (1 month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of gestation.The symptoms of post-traumatic stress disorder will be tracked using the Impact of Event Scale-revisited and the Peritraumatic Dissociative Experiences Questionnaires.The diagnosis of post-traumatic stress disorder will also be clinically confirmed by a psychiatrist during a specific consultation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, prospective, epidemiological, descriptive and analytical study.
| Arm | Type | Receives |
|---|---|---|
| Diagnosis and follow up arm | Experimental | Diagnostic Test: telephone interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- loss pregnancy after 12 weeks of gestation
- consent to participate in the clinical study
Key exclusion criteria (3 listed)
- no french speaking
- psychiatric disease
- participation in another clinical study
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 |
|---|---|---|
| telephone interviewquestionnaire PDEQ et IES-R | Diagnostic test | Diagnosis and follow up arm |
Primary outcome
Assessment of short-term post-traumatic stress disorder in women with fetal loss after 12 weeks of gestation with IES-R scale recorded at 30 days after fetal loss.
Time frame: Telephone interviews are planned 30 days after fetal loss
Assessment of the Impact of Events Scale-Revised (IES-R) score wil be performed by telephone interview by the principal investigator of the present study. IES-R scale has been validated in 1997 (Weiss and Mar) and then validated in French in 2003 (Brunet and St Hilaire). This scale assesses the semi-retarded and retarded consequences of traumatic events. It consists in a 22 items questionnaire measuring symptoms of post-traumatic stress disorder (PTSD), just after traumatic event and after a while. It is based on three main PTSD's elements: avoidance symptoms (items 8, 11, 12, 13, 17, 22), intrusion symptoms (items 1, 3, 5, 6, 9, 16) and hyperarousal (items 2, 4, 10, 14, 15, 18, 21).The patient has to respond using Likert's scale. score interpretations: 24-32: those with scores this high who do not have full PTSD will have partial PTSD. >33 this represents the best cutoff for a probable diagnosis of PTSD
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 6 May 2020.
- Derived from this study: PubMed 35859001Abiola L, Legendre G, Spiers A, Parot-Schinkel E, Hamel JF, Duverger P, Bouet PE, Descamps P, Quelen C, Gillard P, Riquin E. Late fetal demise, a risk factor for post-traumatic stress disorder. Sci Rep. 2022 Jul 20;12(1):12364. doi: 10.1038/s41598-022-16683-5.
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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.
lucile Abiola principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone interview in people with Pregnancy Loss, 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 2 inclusion and 3 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 6 May 2020. 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?
Assessment of short-term post-traumatic stress disorder in women with fetal loss after 12 weeks of gestation with IES-R scale recorded at 30 days after fetal loss. (time frame: Telephone interviews are planned 30 days after fetal loss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433989, which also lists 1 linked publication.
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 6 May 2020.