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

NCT ID: NCT03433989

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2020-02-21

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnosis and follow up arm

Group Type: EXPERIMENTAL

telephone interview

Intervention Type: DIAGNOSTIC_TEST

questionnaire PDEQ et IES-R

Interventions

telephone interview

questionnaire PDEQ et IES-R

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lucile Abiola

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

CHU Angers

Angers, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35859001 (View on PubMed)

Other Identifiers

2017-A02588-45

Identifier Type: -

Identifier Source: org_study_id