Actively Recruiting
Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
Led by University Hospital, Angers · Updated on 2025-11-18
1000
Participants Needed
28
Research Sites
134 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Angers
Lead Sponsor
D
Direction Générale de l'Offre de Soins
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient
- Patient presenting to gynecological emergency department
- Diagnosis of terminated pregnancy or spontaneous loss before 14 weeks of amenorrhea
- Miscarriage announced by an intern
- Affiliated with or benefiting from a social security scheme
- Signed informed consent form
You will not qualify if you...
- Unwanted pregnancy
- Hemorrhagic miscarriage requiring surgery
- Ectopic pregnancy
- Miscarriage from assisted reproduction treatment
- History of three or more miscarriages
- Poor understanding of French language
- Person deprived of liberty
- Under forced psychiatric care
- Subject to legal protection measures
- Unable to give consent
AI-Screening
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Trial Site Locations
Total: 28 locations
1
University Hospital of Amiens
Amiens, France
Actively Recruiting
2
University Hospital of Angers
Angers, France
Actively Recruiting
3
University Hospital of Bordeaux
Bordeaux, France
Not Yet Recruiting
4
University Hospital of Brest
Brest, France
Not Yet Recruiting
5
Femme Mere Enfant Hospital
Bron, France
Not Yet Recruiting
6
University Hospital of Caen
Caen, France
Actively Recruiting
7
CH Chalon-sur-Saône
Chalon-sur-Saône, France
Actively Recruiting
8
CH Cholet
Cholet, France
Actively Recruiting
9
University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
10
University Hospital of Dijon
Dijon, France
Actively Recruiting
11
CHU Grenoble
Grenoble, France
Actively Recruiting
12
Vendée Departmental Hospital center
La Roche-sur-Yon, France
Actively Recruiting
13
Le Mans Hospital
Le Mans, France
Actively Recruiting
14
Jeanne de Flandre Hospital
Lille, France
Actively Recruiting
15
University Hospital of Limoges
Limoges, France
Actively Recruiting
16
Hopital Nord (Marseille Public University Hospital System)
Marseille, France
Actively Recruiting
17
La Conception Hospital (Marseille Public University Hospital System)
Marseille, France
Actively Recruiting
18
University Hospital of Montpellier
Montpellier, France
Actively Recruiting
19
University Hospital of Nancy
Nancy, France
Actively Recruiting
20
University Hospital of Nantes
Nantes, France
Actively Recruiting
21
CHU Nice
Nice, France
Actively Recruiting
22
University Hospital of Nimes
Nîmes, France
Actively Recruiting
23
CHU Orléans
Orléans, France
Actively Recruiting
24
Poissy intercommunal hospital center
Poissy, France
Actively Recruiting
25
University Hsopital of Reims
Reims, France
Actively Recruiting
26
University Hospital of Rennes
Rennes, France
Actively Recruiting
27
University Hospital of Rouen
Rouen, France
Actively Recruiting
28
University Hospital of Saint Etienne
Saint-Etienne, France
Actively Recruiting
Research Team
G
Guillaume Lengendre, MD, PhD
CONTACT
D
DRI UH Angers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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