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

Pregnancy Loss Clinical Trial

— ACTRAMAT-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433989
• Other study ID #: 2017-A02588-45
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: February 21, 2020

Study information

• Verified date: December 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 21, 2020
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fetal Death
• Pregnancy Loss
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Diagnostic Test:
• telephone interview
questionnaire PDEQ et IES-R

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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