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

Last updated: November 25, 2024
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 with metrorrhagia and/orpelvic pain

  • 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, 2026

Connect with a study center

  • University Hospital of Amiens

    Amiens,
    France

    Active - Recruiting

  • University Hospital of Angers

    Angers,
    France

    Active - Recruiting

  • University Hospital of Caen

    Caen,
    France

    Active - Recruiting

  • University Hospital of Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • University Hospital of Dijon

    Dijon,
    France

    Active - Recruiting

  • Vendée Departmental Hospital center

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • Le Mans Hospital

    Le Mans,
    France

    Active - Recruiting

  • Jeanne de Flandre Hospital

    Lille,
    France

    Active - Recruiting

  • University Hospital of Limoges

    Limoges,
    France

    Active - Recruiting

  • Hopital Nord (Marseille Public University Hospital System)

    Marseille,
    France

    Active - Recruiting

  • La Conception Hospital (Marseille Public University Hospital System)

    Marseille,
    France

    Active - Recruiting

  • University Hospital of Montpellier

    Montpellier,
    France

    Active - Recruiting

  • University Hospital of Nancy

    Nancy,
    France

    Active - Recruiting

  • University Hospital of Nantes

    Nantes,
    France

    Active - Recruiting

  • University Hospital of Nimes

    Nimes,
    France

    Active - Recruiting

  • Poissy intercommunal hospital center

    Poissy,
    France

    Active - Recruiting

  • University Hsopital of Reims

    Reims,
    France

    Active - Recruiting

  • University Hospital of Rennes

    Rennes,
    France

    Active - Recruiting

  • University Hospital of Rouen

    Rouen,
    France

    Active - Recruiting

  • University Hospital of Saint Etienne

    Saint Etienne,
    France

    Active - Recruiting

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