search
Back to results

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

Primary Purpose

Pregnancy Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telephone interview
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy Loss focused on measuring Post-Traumatic Stress Disorder, Pregnancy loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnosis and follow up arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
May 4, 2020
Sponsor
University Hospital, Angers
search

1. Study Identification

Unique Protocol Identification Number
NCT03433989
Brief Title
ACTRAMAT-D: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation
Acronym
ACTRAMAT-D
Official Title
Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Loss
Keywords
Post-Traumatic Stress Disorder, Pregnancy loss

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric, prospective, epidemiological, descriptive and analytical study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnosis and follow up arm
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
telephone interview
Intervention Description
questionnaire PDEQ et IES-R
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Telephone interviews are planned 30 days after fetal loss

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lucile Abiola
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35859001
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs