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

Last updated: November 17, 2025
Sponsor: University Hospital, Angers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Miscarriage

Treatment

centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases

centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department

Clinical Study ID

NCT06647849
49RC21_0257
2024-A01244-43
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient

  • Patient presenting to gynaecological emergency department

  • Patient with a diagnosis of terminated pregnancy or spontaneous expulsion of apregnancy < 14 weeks' amenorrhea

  • Patient whose spontaneous miscarriage was announced by an intern

  • Patient affiliated to or benefiting from a social security scheme

  • Patient having signed an informed consent form

Exclusion

Exclusion Criteria:

  • Unwanted pregnancy

  • Spontaneous hemorrhagic miscarriage requiring surgical management

  • Ectopic pregnancy

  • Miscarriage resulting from assisted reproduction treatment

  • Patient with history of miscarriage ≥ 3

  • Poor understanding of the French language

  • Person deprived of liberty by judicial or administrative decision

  • Person under forced psychiatric care

  • Person subject to a legal protection measure

  • Person unable to give consent

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases
Phase:
Study Start date:
November 11, 2024
Estimated Completion Date:
June 11, 2027

Connect with a study center

  • University Hospital of Amiens

    Amiens,
    France

    Site Not Available

  • University Hospital of Amiens

    Amiens 3037854,
    France

    Active - Recruiting

  • University Hospital of Angers

    Angers,
    France

    Site Not Available

  • University Hospital of Angers

    Angers 3037656,
    France

    Active - Recruiting

  • University Hospital of Bordeaux

    Bordeaux 3031582,
    France

    Site Not Available

  • University Hospital of Brest

    Brest 3030300,
    France

    Site Not Available

  • Femme Mere Enfant Hospital

    Bron 3029931,
    France

    Site Not Available

  • University Hospital of Caen

    Caen,
    France

    Site Not Available

  • University Hospital of Caen

    Caen 3029241,
    France

    Active - Recruiting

  • CH Chalon-sur-Saône

    Chalon-sur-Saône,
    France

    Site Not Available

  • CH Chalon-sur-Saône

    Chalon-sur-Saône 3027484,
    France

    Active - Recruiting

  • CH Cholet

    Cholet,
    France

    Site Not Available

  • CH Cholet

    Cholet 3025053,
    France

    Active - Recruiting

  • University Hospital of Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • University Hospital of Clermont-Ferrand

    Clermont-Ferrand 3024635,
    France

    Active - Recruiting

  • University Hospital of Dijon

    Dijon,
    France

    Site Not Available

  • University Hospital of Dijon

    Dijon 3021372,
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU Grenoble

    Grenoble 3014728,
    France

    Active - Recruiting

  • Vendée Departmental Hospital center

    La Roche-sur-Yon,
    France

    Site Not Available

  • Vendée Departmental Hospital center

    La Roche-sur-Yon 3006767,
    France

    Active - Recruiting

  • Le Mans Hospital

    Le Mans,
    France

    Site Not Available

  • Le Mans Hospital

    Le Mans 3003603,
    France

    Active - Recruiting

  • Jeanne de Flandre Hospital

    Lille,
    France

    Site Not Available

  • Jeanne de Flandre Hospital

    Lille 2998324,
    France

    Active - Recruiting

  • University Hospital of Limoges

    Limoges,
    France

    Site Not Available

  • University Hospital of Limoges

    Limoges 2998286,
    France

    Active - Recruiting

  • Hopital Nord (Marseille Public University Hospital System)

    Marseille,
    France

    Site Not Available

  • La Conception Hospital (Marseille Public University Hospital System)

    Marseille,
    France

    Active - Recruiting

  • Hopital Nord (Marseille Public University Hospital System)

    Marseille 2995469,
    France

    Active - Recruiting

  • La Conception Hospital (Marseille Public University Hospital System)

    Marseille 2995469,
    France

    Active - Recruiting

  • University Hospital of Montpellier

    Montpellier,
    France

    Site Not Available

  • University Hospital of Montpellier

    Montpellier 2992166,
    France

    Active - Recruiting

  • University Hospital of Nancy

    Nancy,
    France

    Site Not Available

  • University Hospital of Nancy

    Nancy 2990999,
    France

    Active - Recruiting

  • University Hospital of Nantes

    Nantes,
    France

    Site Not Available

  • University Hospital of Nantes

    Nantes 2990969,
    France

    Active - Recruiting

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CHU Nice

    Nice 2990440,
    France

    Active - Recruiting

  • University Hospital of Nimes

    Nimes,
    France

    Site Not Available

  • University Hospital of Nimes

    Nîmes 2990363,
    France

    Active - Recruiting

  • CHU Orléans

    Orléans,
    France

    Site Not Available

  • CHU Orléans

    Orléans 2989317,
    France

    Active - Recruiting

  • Poissy intercommunal hospital center

    Poissy,
    France

    Site Not Available

  • Poissy intercommunal hospital center

    Poissy 2986501,
    France

    Active - Recruiting

  • University Hsopital of Reims

    Reims,
    France

    Site Not Available

  • University Hsopital of Reims

    Reims 2984114,
    France

    Active - Recruiting

  • University Hospital of Rennes

    Rennes,
    France

    Site Not Available

  • University Hospital of Rennes

    Rennes 2983990,
    France

    Active - Recruiting

  • University Hospital of Rouen

    Rouen,
    France

    Site Not Available

  • University Hospital of Rouen

    Rouen 2982652,
    France

    Active - Recruiting

  • University Hospital of Saint Etienne

    Saint Etienne,
    France

    Site Not Available

  • University Hospital of Saint Etienne

    Saint-Etienne 2980291,
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.