Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients (MISC-TRAIN)

University Hospital, Angers

Status: Enrolling

Conditions: Early Pregnancy Loss; Spontaneous Miscarriage

Treatments: Procedure: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases; Other: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department

Study type: Interventional

Funder types: Other

Identifiers

NCT06647849

2024-A01244-43 (Other Identifier)

49RC21_0257

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Arm "with training"

Experimental group

Description:

Arm "with training": centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases.

Treatment:

Procedure: centers whose interns receive simulation training in the announcement of early spontaneous miscarriage between the 2 inclusion phases

"Untrained" arm

Other group

Description:

"Untrained" arm: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department.

Treatment:

Other: centers with standard in-house management of spontaneous miscarriage/pregnancy arrested in the emergency department