NCT04190043

Brief 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 care…) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

December 4, 2019

Last Update Submit

June 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • evaluate the discrepancy between the patient's experience and the caregivers' experience in front of diagnosis of miscarriage.

    1 day

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with diagnosis of pregnancy loss in the gynecological emergency department of Montpellier Hospital

You may qualify if:

  • 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

You may not qualify if:

  • Subject unable to read or/and write
  • Pregnancy loss \> 15 SA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Clara Compan

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 9, 2019

Study Start

January 1, 2020

Primary Completion

May 1, 2020

Study Completion

May 30, 2020

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations