Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 607
- 试验地点
- 76
- 主要终点
- evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The study will be single-blind. The patient will not know the intern's level of training (trained or untrained).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm "with training"
Arm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases.
干预措施: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases (Procedure)
"Untrained" arm
"Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department.
干预措施: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department (Other)
结局指标
主要结局
evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
时间窗: 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
次要结局
- 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)
- 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(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(18 months)
- 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)