Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06647849
NA

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

Sponsor: University Hospital, Angers

View on ClinicalTrials.gov

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

PROCEDURE

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.

OTHER

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