Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06647849

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here