ACTRAMAT-D: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)

Conditions
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Pregnancy Loss

Intervention / Treatment
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* Diagnostic Test: telephone interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: loss pregnancy after 12 weeks of gestation consent to participate in the clinical study Exclusion Criteria: no french speaking psychiatric disease participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric, prospective, epidemiological, descriptive and analytical study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnosis and follow up arm<br> | Diagnostic Test: telephone interview<br>* questionnaire PDEQ et IES-R<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Telephone interviews are planned 30 days after fetal loss | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Traumatic Stress Disorder, Pregnancy loss