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NCT Number: NCT06647849

Interest of Simulation Training on the Announcement of Early Pregnancy Loss on the Psychological Impact of the Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Early Pregnancy Loss Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Spontaneous Miscarriage Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

The simulation training sessions for the announcement consultation are set up directly in the centers participating in the "with training" arm of the study, after the first phase of patient inclusion. These sessions will take place "in situ" in the center's maternity ward, and will be run by a single team trained in simulation and announcement.

This team of trainers is identical for all centers randomized in the "with training" arm, and is made up of two trainers: an obstetrician-gynecologist and a psychologist.

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

Other

In the participating centers included in the "no training" arm, interns will have no specific training in announcement. Patients will receive information concerning the diagnosis of a terminated pregnancy or miscarriage from interns not trained in simulation.

During the course of the study, training in the announcement of a miscarriage will be offered to interns from centers in the "no training" group.

Primary outcomes

  1. evaluate the impact of specific training for interns in simulated early miscarriage announcements on patients' psychological experiences

    Time frame: 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

Secondary outcomes

  1. Evaluation of the impact on the psychological experience of short-term miscarriage at 1 month

    Time frame: Modification of the "Impact of event scale-revised" post-traumatic stress score at 1 month

  2. evaluation of the patient's feelings about the miscarriage announcement made by the intern at 1 month

    Time frame: Modification of the patient's perception of the announcement of the miscarriage by the resident, using a 1-month questionnaire

  3. Assessing the impact of long-term miscarriage on psychological experience

    Time frame: Modification in the Perinatal Grief Scale score at 6 and 12 months post-miscarriage linked to the introduction of simulated announcement training

  4. Fertility assessment at 6 and 12 months

    Time frame: 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

  5. 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

    Time frame: 18 months

  6. 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

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Acronym: MISC-TRAIN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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