Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Early pregnancy loss (or spontaneous miscarriage) is the loss of a pregnancy before 14 weeks of amenorrhea. Its incidence is estimated at between 10 and 15%, and increases with maternal age. Early pregnancy loss can have major psychological consequences for the woman, her partner and the couple in the aftermath, as well as on the experience and progress of a future pregnancy. In France, the vast majority of miscarriages are diagnosed in gynecological emergencies by interns still in training. Interns, sometimes at the beginning of their training, may find it difficult to announce a miscarriage, and may do so in a way that is clumsy or not adapted to the woman's emotions, which can lead to a bad experience for her. This bad experience could lead to psychological distress, post-traumatic stress and/or impair future fertility. The initiators of this project have already carried out a before-and-after, single-center study, showing a significant improvement in the specific Perinatal Grief Scale score following specific training for interns in first-trimester pregnancy loss. To date, no multicenter randomized study has been conducted to assess the impact of first-trimester pregnancy loss on women's psychological experience.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient

• Patient presenting to gynaecological emergency department

• Patient with a diagnosis of terminated pregnancy or spontaneous expulsion of a pregnancy \< 14 weeks' amenorrhea

• Patient whose spontaneous miscarriage was announced by an intern

• Patient affiliated to or benefiting from a social security scheme

• Patient having signed an informed consent form

Locations
Other Locations
France
University Hospital of Amiens
RECRUITING
Amiens
University Hospital of Angers
RECRUITING
Angers
University Hospital of Caen
RECRUITING
Caen
CH Chalon-sur-Saône
RECRUITING
Chalon-sur-saône
CH Cholet
RECRUITING
Cholet
University Hospital of Clermont-Ferrand
RECRUITING
Clermont-ferrand
University Hospital of Dijon
RECRUITING
Dijon
CHU Grenoble
RECRUITING
Grenoble
Vendée Departmental Hospital center
RECRUITING
La Roche-sur-yon
Le Mans Hospital
RECRUITING
Le Mans
Jeanne de Flandre Hospital
RECRUITING
Lille
University Hospital of Limoges
RECRUITING
Limoges
Hopital Nord (Marseille Public University Hospital System)
RECRUITING
Marseille
La Conception Hospital (Marseille Public University Hospital System)
RECRUITING
Marseille
University Hospital of Montpellier
RECRUITING
Montpellier
University Hospital of Nancy
RECRUITING
Nancy
University Hospital of Nantes
RECRUITING
Nantes
CHU Nice
RECRUITING
Nice
University Hospital of Nimes
RECRUITING
Nîmes
CHU Orléans
RECRUITING
Orléans
Poissy intercommunal hospital center
RECRUITING
Poissy
University Hsopital of Reims
RECRUITING
Reims
University Hospital of Rennes
RECRUITING
Rennes
University Hospital of Rouen
RECRUITING
Rouen
University Hospital of Saint Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Guillaume Lengendre, MD, PhD
guillaume.legendre@chu-angers.fr
+33 02 41 35 36 37
Backup
DRI UH Angers
drci-promotion-interne@chu-angers.fr
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2027-06-11
Participants
Target number of participants: 1000
Treatments
Experimental: Arm with training
Arm with training: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases.
Other: Untrained arm
Untrained arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers
Collaborators: Direction Générale de l'Offre de Soins

This content was sourced from clinicaltrials.gov