MiscarriageNCT04190043
Womens's Experiences of Pregnancy Loss Aftercare in the Gynecological Emergency
An observational study of Miscarriage, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Miscarriage
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with diagnosis of pregnancy loss in the gynecological emergency department of Montpellier Hospital
Who may be able to join
- 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
Who cannot join
- Subject unable to read or/and write
- Pregnancy loss > 15 SA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Womens's Experiences of Pregnancy Loss Aftercare in the Gynecological Emergency Department of Montpellier Hospital.
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.
Read more
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.
- Conditions
- Miscarriage
- Medical subject headings
- Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jan 2020
- Primary completion1 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clara Compan, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190043
- Sponsor's protocol ID
- RECHMPL19_0547
- Status last verified
- Jun 2020
- First submitted
- 4 Dec 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Womens's Experiences of Pregnancy Loss Aftercare in the Gynecological Emergency Department of Montpellier Hospital.
- ClinicalTrials.gov ID
- NCT04190043
- Acronym / sponsor ID
- RECHMPL19_0547
- Conditions
- Miscarriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with diagnosis of pregnancy loss in the gynecological emergency department of Montpellier Hospital
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subject unable to read or/and write
- Pregnancy loss > 15 SA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to evaluate womens's experiences of pregnancy loss aftercare
Time frame: 1 day
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 secondary outcome
evaluate the discrepancy between the patient's experience and the caregivers' experience in front of diagnosis of miscarriage.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Miscarriage
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The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Early Pregnancy Bleeding
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Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Compan principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate womens's experiences of pregnancy loss aftercare (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.