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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03433989
Acronym
ACTRAMAT-D
Enrollment
115
Registered
2018-02-15
Start date
2018-03-07
Completion date
2020-02-21
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Loss

Keywords

Post-Traumatic Stress Disorder, Pregnancy loss

Brief 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 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.

Interventions

DIAGNOSTIC_TESTtelephone interview

questionnaire PDEQ et IES-R

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Monocentric, prospective, epidemiological, descriptive and analytical study.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.Telephone interviews are planned 30 days after fetal lossAssessment 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026