First-trimester PregnancyNCT04101175
Abortions at Strasbourg University Hospitals
An observational study of First-trimester Pregnancy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The number of abortions in France and Strasbourg has been stable for several years. In 2017, 1847 were performed in the Gynecology-Obstetrics Department for 6146 deliveries (23% of all pregnancies). It therefore seems important to evaluate the professional practices, but also the experiences of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- First-trimester Pregnancy
- What is being tested?
- Evaluation of the procedure of abortion
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2019to Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient in the first trimester of pregnancy wishing an abortion
Who may be able to join
- Patient in the first trimester of pregnancy wishing an abortion
- Age: greater than or equal to 18 years.
- Patient affiliated to a social security system
Who cannot join
- Patient after the first trimester pregnancy
- Patient benefiting from a legal protection measure
- Bad understanding of French.
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Antoine KOCH, +33 3 88 12 75 00, antoine.koch@chru-strasbourg.fr
Antoine KOCH
About this study
Official title: A Survey of Best Practices of Abortions at Strasbourg University Hospitals
The number of abortions in France and Strasbourg has been stable for several years. In 2017, 1847 were performed in the Gynecology-Obstetrics Department for 6146 deliveries (23% of all pregnancies). It therefore seems important to evaluate the professional practices, but also the experiences of the patients.
- Conditions
- First-trimester Pregnancy
- Being tested
- Evaluation of the procedure of abortion
- Keywords
- First-trimester pregnancy, Abortions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the procedure of abortionProcedure or surgery
Observational study using questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Request for abortion | Patient in first trimester of pregnancy in request for abortion Receives: Procedure: Evaluation of the procedure of abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the investigator's professional practices regarding abortion, particularly in relation to the recommendations for clinical practice of the National College of French Obstetricians Gynecologists (CNGOF) published in 2016.
The patients will complete a questionnaire
Measured: 6 weeks
Secondary outcomes (1)
Evaluation of the sociological, economic and psychological factors motivating the request for abortion
The patients will complete a questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-trimester PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101175
- Sponsor's protocol ID
- 7472
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Best Practices of Abortions at Strasbourg University Hospitals
- ClinicalTrials.gov ID
- NCT04101175
- Acronym / sponsor ID
- 7472
- Conditions
- First-trimester Pregnancy
- Keywords
- First-trimester pregnancy, Abortions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 24 Sep 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.
The number of abortions in France and Strasbourg has been stable for several years. In 2017, 1847 were performed in the Gynecology-Obstetrics Department for 6146 deliveries (23% of all pregnancies). It therefore seems important to evaluate the professional practices, but also the experiences of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Request for abortion | – | Procedure: Evaluation of the procedure of abortionPatient in first trimester of pregnancy in request for abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in the first trimester of pregnancy wishing an abortion
Key inclusion criteria (3 listed)
- Patient in the first trimester of pregnancy wishing an abortion
- Age: greater than or equal to 18 years.
- Patient affiliated to a social security system
Key exclusion criteria (3 listed)
- Patient after the first trimester pregnancy
- Patient benefiting from a legal protection measure
- Bad understanding of French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the procedure of abortionObservational study using questionnaires | Procedure or surgery | Request for abortion |
Primary outcome
Evaluate the investigator's professional practices regarding abortion, particularly in relation to the recommendations for clinical practice of the National College of French Obstetricians Gynecologists (CNGOF) published in 2016.
Time frame: 6 weeks
The patients will complete a questionnaire
1 secondary outcome
Evaluation of the sociological, economic and psychological factors motivating the request for abortion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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 First-trimester Pregnancy, run by University Hospital, Strasbourg, France 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 3 inclusion and 3 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 24 Sep 2019. 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 Antoine KOCH (+33 3 88 12 83 08, antoine.koch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the investigator's professional practices regarding abortion, particularly in relation to the recommendations for clinical practice of the National College of French Obstetricians Gynecologists (CNGOF) published in 2016. (time frame: 6 weeks). 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 24 Sep 2019.