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Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
Sponsor: University Hospital, Angers
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2024-11-11
Completion Date
2027-06-11
Last Updated
2025-11-18
Healthy Volunteers
No
Interventions
centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases
The simulation training sessions for the announcement consultation are set up directly in the centers participating in the "with training" arm of the study, after the first phase of patient inclusion. These sessions will take place "in situ" in the center's maternity ward, and will be run by a single team trained in simulation and announcement. This team of trainers is identical for all centers randomized in the "with training" arm, and is made up of two trainers: an obstetrician-gynecologist and a psychologist.
centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department
In the participating centers included in the "no training" arm, interns will have no specific training in announcement. Patients will receive information concerning the diagnosis of a terminated pregnancy or miscarriage from interns not trained in simulation. During the course of the study, training in the announcement of a miscarriage will be offered to interns from centers in the "no training" group.
Locations (28)
University Hospital of Amiens
Amiens, France
University Hospital of Angers
Angers, France
University Hospital of Bordeaux
Bordeaux, France
University Hospital of Brest
Brest, France
Femme Mere Enfant Hospital
Bron, France
University Hospital of Caen
Caen, France
CH Chalon-sur-Saône
Chalon-sur-Saône, France
CH Cholet
Cholet, France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
University Hospital of Dijon
Dijon, France
CHU Grenoble
Grenoble, France
Vendée Departmental Hospital center
La Roche-sur-Yon, France
Le Mans Hospital
Le Mans, France
Jeanne de Flandre Hospital
Lille, France
University Hospital of Limoges
Limoges, France
Hopital Nord (Marseille Public University Hospital System)
Marseille, France
La Conception Hospital (Marseille Public University Hospital System)
Marseille, France
University Hospital of Montpellier
Montpellier, France
University Hospital of Nancy
Nancy, France
University Hospital of Nantes
Nantes, France
CHU Nice
Nice, France
University Hospital of Nimes
Nîmes, France
CHU Orléans
Orléans, France
Poissy intercommunal hospital center
Poissy, France
University Hsopital of Reims
Reims, France
University Hospital of Rennes
Rennes, France
University Hospital of Rouen
Rouen, France
University Hospital of Saint Etienne
Saint-Etienne, France