Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological … (NCT06647849) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients
France607 participantsStarted 2024-11-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences
Timeframe: 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