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Interest of Simulation Traini...

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

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2027-06-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Early Pregnancy Loss Spontaneous Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The study will be single-blind. The patient will not know the intern's level of training (trained or untrained).

Study Groups

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Arm "with training"

Arm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

"Untrained" arm

"Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department.

Group Type OTHER

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

Intervention Type OTHER

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.

Interventions

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

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers