Medical Termination of PregnancyIMGEPRNCT04294212
Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital
An observational study of Medical Termination of Pregnancy, run by University Hospital, Brest at 1 site in France.
Trial summary
This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Termination of Pregnancy
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 10 Aug 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients having experienced a medical termination of pregnancy in Brest Hospital
Who may be able to join
- Patient having experienced a medical termination of pregnancy in Brest Hospital
- Medical termination of pregnancy after 14 weeks
- Induction for natural delivery
- No opposition
Who cannot join
- Medical termination of pregnancy before 14 weeks
- Selective termination of pregnancy (multiple pregnancy)
- Caesarean
- Patient not speaking french
- Patient's refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Anne-Hélène saliou, 02-98-22-35-33, anne-helene.saliou@chu-brest.fr
About this study
This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data.
- Conditions
- Medical Termination of Pregnancy
- Keywords
- Pregnancy loss, lived from patients, medical termination of pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction score
answers to a satisfaction questionnaire based on a numerical scale ranging from 0 (dissatisfaction) to 3 (satisfaction), then calculation of the overall score
Measured: One day
Secondary outcomes (1)
satisfaction score by indicator
satisfaction questionnaire divided into several parts according to an indicator
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Feb 2020
- Primary completion10 Aug 2020 (estimated)
- Study completion10 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Termination of PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294212
- Sponsor's protocol ID
- IMGEPR (29BRC19.0245)
- Acronym
- IMGEPR
- Status last verified
- Mar 2019
- First submitted
- 2 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital
- ClinicalTrials.gov ID
- NCT04294212
- Acronym / sponsor ID
- IMGEPR / IMGEPR (29BRC19.0245)
- Conditions
- Medical Termination of Pregnancy
- Keywords
- Pregnancy loss, lived from patients, medical termination of pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Aug 2020 (estimated)
- Study completion
- 10 Aug 2020 (estimated)
- First posted
- 4 Mar 2020 (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.
This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients having experienced a medical termination of pregnancy in Brest Hospital
Key inclusion criteria (4 listed)
- Patient having experienced a medical termination of pregnancy in Brest Hospital
- Medical termination of pregnancy after 14 weeks
- Induction for natural delivery
- No opposition
Key exclusion criteria (5 listed)
- Medical termination of pregnancy before 14 weeks
- Selective termination of pregnancy (multiple pregnancy)
- Caesarean
- Patient not speaking french
- Patient's refusal
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
Overall satisfaction score
Time frame: One day
answers to a satisfaction questionnaire based on a numerical scale ranging from 0 (dissatisfaction) to 3 (satisfaction), then calculation of the overall score
1 secondary outcome
satisfaction score by indicator
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 Medical Termination of Pregnancy, run by University Hospital, Brest 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Hélène Saliou (02-98-22-35-33, anne-helene.saliou@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall satisfaction score (time frame: One 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 4 Mar 2020.