EICHORCondition: Early Pregnancy Loss · Spontaneous Miscarriage · Sponsor: University Hospital, Angers
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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.
This description comes directly from the study's public registry record.
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University Hospital of Amiens | Amiens, France | — |
| University Hospital of Angers | Angers, France | — |
| University Hospital of Bordeaux | Bordeaux, France | — |
| University Hospital of Brest | Brest, France | — |
| Femme Mere Enfant Hospital | Bron, France | — |
| University Hospital of Caen | Caen, France | — |
| CH Chalon-sur-Saône | Chalon-sur-Saône, France | — |
| CH Cholet | Cholet, France | — |
| University Hospital of Clermont-Ferrand | Clermont-Ferrand, France | — |
| University Hospital of Dijon | Dijon, France | — |
| CHU Grenoble | Grenoble, France | — |
| Vendée Departmental Hospital center | La Roche-sur-Yon, France | — |
+ 16 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06647849