Early Pregnancy LossMISC-TRAINNCT06647849
Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
A study testing centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases and centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department in people with Early Pregnancy Loss and Spontaneous Miscarriage, run by University Hospital, Angers at 28 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Pregnancy Loss, Spontaneous Miscarriage
- What is being tested?
- centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases and centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 28 sitesFrance
- Study dates
- 11 Nov 2024to 11 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
University Hospital of Amiens
Amiens
University Hospital of Angers
Angers
University Hospital of Bordeaux
Bordeaux
University Hospital of Brest
Brest
Femme Mere Enfant Hospital
Bron
University Hospital of Caen
Caen
CH Chalon-sur-Saône
Chalon-sur-Saône
CH Cholet
Cholet
University Hospital of Clermont-Ferrand
Clermont-Ferrand
University Hospital of Dijon
Dijon
CHU Grenoble
Grenoble
Vendée Departmental Hospital center
La Roche-sur-Yon
Le Mans Hospital
Le Mans
Jeanne de Flandre Hospital
Lille
University Hospital of Limoges
Limoges
Hopital Nord (Marseille Public University Hospital System)
Marseille
La Conception Hospital (Marseille Public University Hospital System)
Marseille
University Hospital of Montpellier
Montpellier
University Hospital of Nancy
Nancy
University Hospital of Nantes
Nantes
CHU Nice
Nice
University Hospital of Nimes
Nîmes
CHU Orléans
Orléans
Poissy intercommunal hospital center
Poissy
University Hsopital of Reims
Reims
University Hospital of Rennes
Rennes
University Hospital of Rouen
Rouen
University Hospital of Saint Etienne
Saint-Etienne
About this study
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.
Read more
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.
- Conditions
- Early Pregnancy Loss, Spontaneous Miscarriage
- Being tested
- 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
- Keywords
- spontaneous miscarriage, early pregnancy loss, training for interns
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phasesProcedure or surgery
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.
centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency departmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 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. Receives: Other: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start11 Nov 2024
- Primary completion11 Jun 2027 (estimated)
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy LossStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Guillaume Legendre, MD, PhD, Study director, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647849
- Sponsor's protocol ID
- 49RC21_0257
- Other IDs
- 2024-A01244-43
- Acronym
- MISC-TRAIN
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
- ClinicalTrials.gov ID
- NCT06647849
- Acronym / sponsor ID
- MISC-TRAIN / 49RC21_0257
- Conditions
- Early Pregnancy Loss, Spontaneous Miscarriage
- Keywords
- spontaneous miscarriage, early pregnancy loss, training for interns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 607 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 11 Jun 2027 (estimated)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm "with training" | Experimental | Procedure: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phasesArm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases. |
| "Untrained" arm | Other | Other: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department"Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Unwanted pregnancy
- Spontaneous hemorrhagic miscarriage requiring surgical management
- Ectopic pregnancy
- Miscarriage resulting from assisted reproduction treatment
- Patient with history of miscarriage ≥ 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phasesThe 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. | Procedure or surgery | Arm "with training" |
| centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency departmentIn 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. | Other | "Untrained" arm |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Early Pregnancy Loss
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Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Abortion in First Trimester, Abortion Early
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Legendre, MD, PhD study director
University Hospital of Angers
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases and centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department in people with Early Pregnancy Loss and Spontaneous Miscarriage, run by University Hospital, Angers at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.