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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04190043
Other study ID # RECHMPL19_0547
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date May 30, 2020

Study information

Verified date June 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction: Scientific papers on the womens's experiences of pregnancy loss aftercare in the emergency department show that how announcement is made and how much caregivers show empathy to women, help women to face this difficult moment. However, in most studies, women say they did not have enough information nor support from the medical teams.

Diagnosis of miscarriage in the emergency department is the routine for the caregiver but is often experienced by the woman as the loss of a child.

This study has for goal to bring to light the discrepancy between the caregivers's experience and the women's experience :the given information, the time for consultation, the empathy.

Methods : 2 months after the diagnosis of miscarriage in the emergency room, patients receive a phone call with explanations about the project. If the patient gives her consent, she receives a computer questionnaire by email (questions about : reasons for coming to the emergency room, circumstances of announcement, information given in the emergency room, satisfaction with the careā€¦) In parallel, caregivers have to complete a questionnaire about the same parameters.

The main objective of this study is to evaluate womens's experiences of pregnancy loss aftercare in the emergency department of Montpellier Hospital.

The second objective is to assess the discrepancy between the patient's experience and the caregivers' experience in this situation with the aim of suggesting improvement.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 30, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion criteria :

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

- Women > 18 years old

- French speaker

- Diagnosis and management of miscarriage / pregnancy loss in the emergency department

- Miscarriage / pregnancy loss < 15 SA

Exclusion criteria:

- Subject unable to read or/and write

- Pregnancy loss > 15 SA.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary to evaluate womens's experiences of pregnancy loss aftercare Computer questionnaire (Patient characteristics, Reason for coming to the emergency room, Circumstances of the announcement, Information given to the emergency room, Reception in emergencies) with Patient satisfied or not with the care in emergencies department: 0 -> 5 1 day
Secondary evaluate the discrepancy between the patient's experience and the caregivers' experience in front of diagnosis of miscarriage. Computer questionnaire for the caregivers (Circumstances of the announcement, Information given to the emergency room, Reception in emergencies) 1 day
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