Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
MISC-TRAIN
2 other identifiers
interventional
1,000
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Typical duration for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2024
CompletedFirst Posted
Study publicly available on registry
October 18, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 11, 2027
November 18, 2025
June 1, 2025
1.5 years
October 9, 2024
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
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 Outcomes (6)
Evaluation of the impact on the psychological experience of short-term miscarriage 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
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
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 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
18 months
- +1 more secondary outcomes
Study Arms (2)
Arm "with training"
EXPERIMENTALArm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases.
"Untrained" arm
OTHER"Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University Hospital of Amiens
Amiens, France
University Hospital of Angers
Angers, France
University Hospital of Bordeaux
Bordeaux, France
University Hospital of Brest
Brest, France
Femme Mere Enfant Hospital
Bron, France
University Hospital of Caen
Caen, France
CH Chalon-sur-Saône
Chalon-sur-Saône, France
CH Cholet
Cholet, France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
University Hospital of Dijon
Dijon, France
CHU Grenoble
Grenoble, France
Vendée Departmental Hospital center
La Roche-sur-Yon, France
Le Mans Hospital
Le Mans, France
Jeanne de Flandre Hospital
Lille, France
University Hospital of Limoges
Limoges, France
Hopital Nord (Marseille Public University Hospital System)
Marseille, France
La Conception Hospital (Marseille Public University Hospital System)
Marseille, France
University Hospital of Montpellier
Montpellier, France
University Hospital of Nancy
Nancy, France
University Hospital of Nantes
Nantes, France
CHU Nice
Nice, France
University Hospital of Nimes
Nîmes, France
CHU Orléans
Orléans, France
Poissy intercommunal hospital center
Poissy, France
University Hsopital of Reims
Reims, France
University Hospital of Rennes
Rennes, France
University Hospital of Rouen
Rouen, France
University Hospital of Saint Etienne
Saint-Etienne, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guillaume Legendre, MD, PhD
University Hospital of Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The study will be single-blind. The patient will not know the intern's level of training (trained or untrained).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2024
First Posted
October 18, 2024
Study Start
November 11, 2024
Primary Completion (Estimated)
May 11, 2026
Study Completion (Estimated)
June 11, 2027
Last Updated
November 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share