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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
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.
University Hospital of Amiens
Amiens, France
RECRUITINGUniversity Hospital of Angers
Angers, France
RECRUITINGUniversity Hospital of Bordeaux
Bordeaux, France
NOT_YET_RECRUITINGUniversity Hospital of Brest
Brest, France
NOT_YET_RECRUITINGFemme Mere Enfant Hospital
Bron, France
NOT_YET_RECRUITINGUniversity Hospital of Caen
Caen, France
RECRUITINGCH Chalon-sur-Saône
Chalon-sur-Saône, France
RECRUITINGCH Cholet
Cholet, France
RECRUITINGUniversity Hospital of Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGUniversity Hospital of Dijon
Dijon, France
RECRUITING...and 18 more locations
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.