Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
- Conditions
- Early Pregnancy LossSpontaneous Miscarriage
- Registration Number
- NCT06647849
- Lead Sponsor
- University Hospital, Angers
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (20)
University Hospital of Amiens
🇫🇷Amiens, France
University Hospital of Angers
🇫🇷Angers, France
University Hospital of Caen
🇫🇷Caen, France
University Hospital of Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
University Hospital of Dijon
🇫🇷Dijon, France
Hopital Nord (Marseille Public University Hospital System)
🇫🇷Marseille, France
University Hospital of Nancy
🇫🇷Nancy, France
University Hospital of Nantes
🇫🇷Nantes, France
University Hospital of Nimes
🇫🇷Nimes, France
Vendée Departmental Hospital center
🇫🇷La Roche-sur-Yon, France
La Conception Hospital (Marseille Public University Hospital System)
🇫🇷Marseille, France
Le Mans Hospital
🇫🇷Le Mans, France
Jeanne de Flandre Hospital
🇫🇷Lille, France
University Hospital of Montpellier
🇫🇷Montpellier, France
Poissy intercommunal hospital center
🇫🇷Poissy, France
University Hospital of Limoges
🇫🇷Limoges, 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