NCT06647849 Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
| NCT ID | NCT06647849 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Early Pregnancy Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2026-05-11 |
Trial Parameters
Eligibility Fast-Check
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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 * 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