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

NCT03433989 | Completed

• 1 other identifier: 2017-A02588-45
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Loss

Keywords

Post-Traumatic Stress Disorder; Pregnancy loss

Outcome Measures

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.

  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

Study Arms (1)

Diagnosis and follow up arm

EXPERIMENTAL

Diagnostic Test: telephone interview

Interventions

telephone interview DIAGNOSTIC_TEST

questionnaire PDEQ et IES-R

Diagnosis and follow up arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• loss pregnancy after 12 weeks of gestation
• consent to participate in the clinical study

You may not qualify if:

• no french speaking
• psychiatric disease
• participation in another clinical study

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49100, France

Location

Related Publications (1)

• 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.

  PMID: 35859001 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• lucile Abiola

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective, epidemiological, descriptive and analytical study.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 15, 2018
• Study Start: March 7, 2018
• Primary Completion: November 21, 2019
• Study Completion: February 21, 2020
• Last Updated: May 6, 2020

Record last verified: 2019-12

Locations

FR (1)