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

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT03433989
Collaborator
(none)
115
1
1
23.5
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: telephone interview
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Monocentric, prospective, epidemiological, descriptive and analytical study.Monocentric, prospective, epidemiological, descriptive and analytical study.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)
Actual Study Start Date :
Mar 7, 2018
Actual Primary Completion Date :
Nov 21, 2019
Actual Study Completion Date :
Feb 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnosis and follow up arm

Diagnostic Test: telephone interview
questionnaire PDEQ et IES-R

Outcome Measures

Primary Outcome Measures

  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. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Angers Angers France 49100

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

  • Principal Investigator: lucile Abiola, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT03433989
Other Study ID Numbers:
  • 2017-A02588-45
First Posted:
Feb 15, 2018
Last Update Posted:
May 6, 2020
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Angers
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2020