Training interns to announce early pregnancy loss
Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
This study tests whether training interns to deliver news about early pregnancy loss can help reduce the emotional pain for patients going through a miscarriage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Angers Government |
| Locations | 28 sites (Amiens and 27 other locations) |
| Trial ID | NCT06647849 on ClinicalTrials.gov |
What this trial studies
This study focuses on the psychological impact of early pregnancy loss, specifically spontaneous miscarriage, and aims to improve the way interns announce such losses to patients. By providing simulation training to interns in gynecological emergency departments, the study seeks to enhance their communication skills and sensitivity when delivering difficult news. The approach involves comparing outcomes between centers that implement this training and those that follow standard procedures. The goal is to reduce psychological distress for patients experiencing miscarriage.
Who should consider this trial
Good fit: Ideal candidates include adult patients presenting with symptoms of early pregnancy loss who have had their diagnosis communicated by an intern.
Not a fit: Patients who have experienced unwanted pregnancies or those requiring surgical management for their miscarriage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved emotional support for patients experiencing early pregnancy loss, potentially reducing psychological trauma.
How similar studies have performed: Previous studies have shown significant improvements in patient experiences following similar training interventions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Amiens and 27 other locations
- University Hospital of Amiens — Amiens, France (Recruiting)
- University Hospital of Angers — Angers, France (Recruiting)
- University Hospital of Bordeaux — Bordeaux, France (Not_yet_recruiting)
- University Hospital of Brest — Brest, France (Not_yet_recruiting)
- Femme Mere Enfant Hospital — Bron, France (Not_yet_recruiting)
- University Hospital of Caen — Caen, France (Recruiting)
- CH Chalon-sur-Saône — Chalon-sur-Saône, France (Recruiting)
- CH Cholet — Cholet, France (Recruiting)
- University Hospital of Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- University Hospital of Dijon — Dijon, France (Recruiting)
- CHU Grenoble — Grenoble, France (Recruiting)
- Vendée Departmental Hospital center — La Roche-sur-Yon, France (Recruiting)
- Le Mans Hospital — Le Mans, France (Recruiting)
- Jeanne de Flandre Hospital — Lille, France (Recruiting)
- University Hospital of Limoges — Limoges, France (Recruiting)
- Hopital Nord (Marseille Public University Hospital System) — Marseille, France (Recruiting)
- La Conception Hospital (Marseille Public University Hospital System) — Marseille, France (Recruiting)
- University Hospital of Montpellier — Montpellier, France (Recruiting)
- University Hospital of Nancy — Nancy, France (Recruiting)
- University Hospital of Nantes — Nantes, France (Recruiting)
- CHU Nice — Nice, France (Recruiting)
- University Hospital of Nimes — Nîmes, France (Recruiting)
- CHU Orléans — Orléans, France (Recruiting)
- Poissy intercommunal hospital center — Poissy, France (Recruiting)
- University Hsopital of Reims — Reims, France (Recruiting)
- University Hospital of Rennes — Rennes, France (Recruiting)
- University Hospital of Rouen — Rouen, France (Recruiting)
- University Hospital of Saint Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Study coordinator: Guillaume Lengendre, MD, PhD
- Email: guillaume.legendre@chu-angers.fr
- Phone: +33 02 41 35 36 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.