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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01244-43 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm "with training" | Experimental | Arm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases. |
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| "Untrained" arm | Other | "Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Legendre, MD, PhD | University Hospital of Angers | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Amiens | Amiens | France | ||||
| University Hospital of Angers |
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The study will be single-blind. The patient will not know the intern's level of training (trained or untrained).
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| centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department | 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. |
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| 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 |
| 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 | 18 months |
| 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 |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015337 | Multicenter Studies as Topic |
| ID | Term |
|---|---|
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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