Abortion; Attempted, MedicalNCT02304835
Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion
An observational study of Abortion; Attempted, Medical, run by Nordic Pharma SAS at 1 site in France.
Trial summary
This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres. The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion; Attempted, Medical
- How many people
- 322 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Nov 2013
- 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: Women asking for medical abortion
Who may be able to join
- Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.
- Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.
- Informed patients accepting the computer processing of their medical data and their right of access and correction.
Who cannot join
- Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.
- Patients with contraindications to medical abortion.
- Patients with severe and progressive disease.
- Patients unable to complete a questionnaire.
- Patients refusing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.
The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
- Conditions
- Abortion; Attempted, Medical
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
There was concordance if :
- The result of urinary test is < 1000 IU/L and the value of β-hCG blood measurement was < 1000 IU/L, Or if
- The result of urinary test is ≥ 1000 iu/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.
There was discrepancy if:
- The result of urinary test is ≥ 1000 IU/L and the value of β-hCG blood measurement was < 1000 IU/L, Or if
- The result of urinary test is < 1000 IU/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.
Measured: At the follow-up at 2-3 weeks after inclusion
Secondary outcomes (1)
Acceptability of the urinary semi-quantitative test by the patient
The analysis of the acceptability is descriptive:
- The rate of patients who performed the urinary test.
- Assessment of the urinary test by physicIan : very easy/easy/difficult/Impossible
- The assessment by the patient: questionnaire (Have you found the explanations given sufficient for performing the test?, How did you find the carrying out of this test? What are your feelings about checking the results of the medical abortion yourself?)
Measured: at the follow up at 2-3 weeks after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion; Attempted, MedicalStudies of the same condition, open and under way.
- 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle HASSOUN, MD, Principal investigator, Cabinet Médical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304835
- Sponsor's protocol ID
- BETINA
- Status last verified
- Dec 2014
- First submitted
- 25 Nov 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion
- ClinicalTrials.gov ID
- NCT02304835
- Acronym / sponsor ID
- BETINA
- Conditions
- Abortion; Attempted, Medical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Nordic Pharma SASIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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 was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.
The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women asking for medical abortion
Key inclusion criteria (3 listed)
- Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.
- Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.
- Informed patients accepting the computer processing of their medical data and their right of access and correction.
Key exclusion criteria (5 listed)
- Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.
- Patients with contraindications to medical abortion.
- Patients with severe and progressive disease.
- Patients unable to complete a questionnaire.
- Patients refusing to participate in the study.
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
concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
Time frame: At the follow-up at 2-3 weeks after inclusion
There was concordance if : * The result of urinary test is < 1000 IU/L and the value of β-hCG blood measurement was < 1000 IU/L, Or if * The result of urinary test is ≥ 1000 iu/L and the value of β-hCG blood measurement was ≥ 1000 IU/L. There was discrepancy if: * The result of urinary test is ≥ 1000 IU/L and the value of β-hCG blood measurement was < 1000 IU/L, Or if * The result of urinary test is < 1000 IU/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.
1 secondary outcome
Acceptability of the urinary semi-quantitative test by the patient
Time frame: at the follow up at 2-3 weeks after the inclusion
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 Dec 2014.
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.
Danielle HASSOUN, MD principal investigator
Cabinet Médical
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 Abortion; Attempted, Medical, run by Nordic Pharma SAS 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 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: finished, as of the sponsor's last update on 5 Dec 2014. 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?
concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement. (time frame: At the follow-up at 2-3 weeks after inclusion). 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 Dec 2014.