Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients (MISC-TRAIN)

November 17, 2025 updated by: University Hospital, Angers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
      • Angers, France
      • Bordeaux, France
        • Not yet recruiting
        • University Hospital of Bordeaux
        • Contact:
          • Loic Sentilhes
      • Brest, France
        • Not yet recruiting
        • University Hospital of Brest
        • Contact:
          • Karine MORCEL
      • Bron, France
        • Not yet recruiting
        • Femme Mere Enfant Hospital
        • Contact:
          • Charles-André PHILIP
      • Caen, France
        • Recruiting
        • University hospital of Caen
        • Contact:
      • Chalon-sur-Saône, France
        • Recruiting
        • CH Chalon-sur-Saône
        • Contact:
      • Cholet, France
        • Recruiting
        • CH Cholet
        • Contact:
          • Mariette BRUAND
      • Clermont-Ferrand, France
        • Recruiting
        • University Hospital of Clermont-Ferrand
        • Contact:
      • Dijon, France
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • Thierry MICHY
      • La Roche-sur-Yon, France
        • Recruiting
        • Vendée Departmental Hospital center
        • Contact:
      • Le Mans, France
        • Recruiting
        • Le Mans Hospital
        • Contact:
      • Lille, France
      • Limoges, France
      • Marseille, France
        • Recruiting
        • Hopital Nord (Marseille Public University Hospital System)
        • Contact:
      • Marseille, France
        • Recruiting
        • La Conception Hospital (Marseille Public University Hospital System)
        • Contact:
      • Montpellier, France
      • Nancy, France
        • Recruiting
        • University Hospital of Nancy
        • Contact:
      • Nantes, France
      • Nice, France
        • Recruiting
        • CHU Nice
        • Contact:
          • Jérôme DELOTTE
      • Nîmes, France
      • Orléans, France
        • Recruiting
        • CHU Orléans
        • Contact:
          • Hélène GBAGUIDI
      • Poissy, France
        • Recruiting
        • Poissy intercommunal hospital center
        • Contact:
      • Reims, France
        • Recruiting
        • University Hsopital of Reims
        • Contact:
      • Rennes, France
      • Rouen, France
      • Saint-Etienne, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient
  • Patient presenting to gynaecological emergency department
  • Patient with a diagnosis of terminated pregnancy or spontaneous expulsion of a pregnancy < 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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm "with training"
Arm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases.
Procedure: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases

The simulation training sessions for the announcement consultation are set up directly in the centers participating in the "with training" arm of the study, after the first phase of patient inclusion. These sessions will take place "in situ" in the center's maternity ward, and will be run by a single team trained in simulation and announcement.

This team of trainers is identical for all centers randomized in the "with training" arm, and is made up of two trainers: an obstetrician-gynecologist and a psychologist.
Other: "Untrained" arm
"Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department.
Other: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department

In the participating centers included in the "no training" arm, interns will have no specific training in announcement. Patients will receive information concerning the diagnosis of a terminated pregnancy or miscarriage from interns not trained in simulation.

During the course of the study, training in the announcement of a miscarriage will be offered to interns from centers in the "no training" group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
Time Frame: The primary endpoint was the significant change in the Perinatal Grief Scale at 3 months post-miscarriage linked to the implementation of the simulation training
The primary endpoint was the significant change in the Perinatal Grief Scale at 3 months post-miscarriage linked to the implementation of the simulation training

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the impact on the psychological experience of short-term miscarriage at 1 month
Time Frame: Modification of the "Impact of event scale-revised" post-traumatic stress score at 1 month
Modification of the "Impact of event scale-revised" post-traumatic stress score at 1 month
evaluation of the patient's feelings about the miscarriage announcement made by the intern at 1 month
Time Frame: Modification of the patient's perception of the announcement of the miscarriage by the resident, using a 1-month questionnaire
Modification of the patient's perception of the announcement of the miscarriage by the resident, using a 1-month questionnaire
Assessing the impact of long-term miscarriage on psychological experience
Time Frame: Modification in the Perinatal Grief Scale score at 6 and 12 months post-miscarriage linked to the introduction of simulated announcement training
Modification in the Perinatal Grief Scale score at 6 and 12 months post-miscarriage linked to the introduction of simulated announcement training
Fertility assessment at 6 and 12 months
Time Frame: Time to decision to have a new pregnancy and increase in clinical pregnancy rates, progressive pregnancy rates > 14 weeks' amenorrhea at 6 and 12 months
Time to decision to have a new pregnancy and increase in clinical pregnancy rates, progressive pregnancy rates > 14 weeks' amenorrhea at 6 and 12 months
Comparing the difference of " Impact of event scale-revised" score in patients depending on whether they are cared for by an intern whose most recent training in prognosis was less than or more than 6 months ago
Time Frame: 18 months
18 months
Comparing the difference of " Impact of event scale-revised" score in patients depending on whether they were cared for by an intern who had received a single training course less than 6 months old, or by an intern who had received two training courses
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Direction Générale de l'Offre de Soins

Investigators

  • Study Director: Guillaume Legendre, MD, PhD, University hospital of Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

May 11, 2026

Study Completion (Estimated)

June 11, 2027

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC21_0257
  • 2024-A01244-43 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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