Clinical trial NCT06647849: Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
Official title: Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Pregnancy Loss
Spontaneous Miscarriage
Keywords: spontaneous miscarriage
early pregnancy loss
training for interns
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2024-10-18
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient presenting to gynaecological emergency department with metrorrhagia and/or pelvic pain
* 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

Primary outcomes:
measure: evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
timeFrame: 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:
measure: Evaluation of the impact on the psychological experience of short-term miscarriage at 1 month
timeFrame: Modification of the "Impact of event scale-revised" post-traumatic stress score at 1 month
measure: evaluation of the patient's feelings about the miscarriage announcement made by the intern at 1 month
timeFrame: Modification of the patient's perception of the announcement of the miscarriage by the resident, using a 1-month questionnaire
measure: Assessing the impact of long-term miscarriage on psychological experience
timeFrame: Modification in the Perinatal Grief Scale score at 6 and 12 months post-miscarriage linked to the introduction of simulated announcement training
measure: Fertility assessment at 6 and 12 months
timeFrame: 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
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital of Amiens
city: Angers
country: France
facility: University Hospital of Angers
city: Caen
country: France
facility: University Hospital of Caen
city: Clermont-Ferrand
country: France
facility: University Hospital of Clermont-Ferrand
city: Dijon
country: France
facility: University Hospital of Dijon
city: La Roche-sur-Yon
country: France
facility: Vendée Departmental Hospital center
city: Le Mans
country: France
facility: Le Mans Hospital
city: Lille
country: France
facility: Jeanne de Flandre Hospital
city: Limoges
country: France
facility: University Hospital of Limoges
city: Marseille
country: France
facility: Hopital Nord (Marseille Public University Hospital System)
city: Marseille
country: France
facility: La Conception Hospital (Marseille Public University Hospital System)
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nancy
country: France
facility: University Hospital of Nancy
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nimes
country: France
facility: University Hospital of Nimes
city: Poissy
country: France
facility: Poissy intercommunal hospital center
city: Reims
country: France
facility: University Hsopital of Reims
city: Rennes
country: France
facility: University Hospital of Rennes
city: Rouen
country: France
facility: University Hospital of Rouen
city: Saint Etienne
country: France
facility: University Hospital of Saint Etienne
Study officials:
affiliation: University Hospital of Angers
name: Guillaume Legendre, MD, PhD
role: STUDY_DIRECTOR
References: