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
56 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 defined as the loss of a pregnancy before 14 weeks of amenorrhea and occurs in about 10 to 15% of pregnancies, with higher risks as maternal age increases. This research investigates how specific simulation training for interns on announcing early pregnancy loss affects the psychological experience of women following miscarriage, addressing the emotional impact and potential long-term effects such as psychological distress and fertility concerns. The study is a randomized, single-blind, multicenter trial conducted by the University Hospital, Angers. Participants are assigned to one of two groups: the "with training" group includes centers where interns receive specialized simulation training on delivering miscarriage news, conducted by a team of an obstetrician-gynecologist and a psychologist within the maternity ward. The "untrained" group centers follow standard care where interns do not receive this specific training. Interns in the untrained group will be offered training after the study period. The training aims to improve communication skills and patient experience during the announcement of early spontaneous miscarriage. Women enrolled in the study are evaluated over time with psychological assessments including the Perinatal Grief Scale at 3, 6, and 12 months post-miscarriage, and the Impact of Event Scale-Revised at 1 and 18 months. Additional evaluations include patients' feelings about how the miscarriage announcement was made, and fertility outcomes such as time to new pregnancy and pregnancy rates beyond 14 weeks. The study measures how simulated training may influence these outcomes, with follow-up visits and questionnaires conducted to monitor the psychological impact and fertility status.
CONDITIONS
Brief 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
- Presenting to gynecological emergency department
- Diagnosed with terminated pregnancy or spontaneous miscarriage before 14 weeks' amenorrhea
- Miscarriage announced by an intern
- Affiliated to or benefiting from social security
- Signed informed consent form
You will not qualify if you...
- Unwanted pregnancy
- Spontaneous hemorrhagic miscarriage requiring surgical management
- Ectopic pregnancy
- Miscarriage from assisted reproduction treatment
- History of 3 or more miscarriages
- Poor understanding of French language
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person under legal protection measure
- Unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At time of diagnosis and announcement
Participants receive miscarriage announcement by interns who either have simulation training in early miscarriage announcement or standard care without specific training.
1 visit (in-person) at the emergency department
Duration - Up to 18 months post-miscarriage
Participants' psychological experience and fertility outcomes are assessed at multiple time points after miscarriage announcement.
Assessments at 1 month, 3 months, 6 months, 12 months, and 18 months
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
D
DRI UH Angers
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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