Skip to main content
OpenTrials
Completed

NCT Number: NCT03433989

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Loss Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telephone interview

Diagnostic Test

questionnaire PDEQ et IES-R

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: ACTRAMAT-D

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 15, 2018
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.