Drug AbortionCHECK-TOPNCT02792556
Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).
An observational study of Drug Abortion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Drug Abortion
- What is being tested?
- Urine pregnancy test
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2018
- 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: adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake.
Who may be able to join
- Women ≥18 years of age
- Undergoing drug abortion in Orthogenic Departement, Croix-Rousse Hospital, Lyon
- Intrauterine pregnancy, single or multiple, until 8 weeks of amenorrhea
- Agreeing to participate in the study after receiving information note
- Affiliated to a social security system
- Not subject to a measure of legal protection
Who cannot join
- Women <18 years
- Ineligible patient to drug abortion
- Patient practicing a surgical abortion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004
Corinne REBELLE, +33 4 72 07 16 63, corine.rebelle@chu-lyon.fr
About this study
Official title: Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.
The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.
Read more
The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.
In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.
To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.
The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.
This is a monocentric observational study.
- Conditions
- Drug Abortion
- Being tested
- Urine pregnancy test
- Keywords
- drug abortion, urine pregnancy test, negative predictive value, check Top test, transvaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine pregnancy testDevice
Urine pregnancy test Check Top after transvaginal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| patient having a drug abortion | Urine pregnancy test for adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake. Receives: Device: Urine pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value of urine pregnancy test CHECK TOP
Negative predictive value of urine pregnancy test CHECK TOP taking as reference transvaginal ultrasound.
A negative result at transvaginal ultrasound will be defined as the absence of ongoing pregnancy. An ongoing pregnancy is characterized by the presence of gestational sac, yolk sac and/or embryo with cardiac activity. A positive result will be retained only in case of ongoing pregnancy.
Check Top test will be considered as negative if only one colored line appears in the control window, without any line in the result window. It will be considered as positive if two colored lines are present in the result window, corresponding to a β-HCG level > 1000 IU/ml.
Measured: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Secondary outcomes (4)
Positive predictive value of urine pregnancy test Check Top
Positive predictive value of urine pregnancy test Check Top compared to transvaginal ultrasound.
Measured: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Sensibility of urine pregnancy test Check Top
Sensibility of urine pregnancy test Check Top compared to transvaginal ultrasound.
Measured: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Specificity of urine pregnancy test Check Top
Specificity of urine pregnancy test Check Top compared to transvaginal ultrasound.
Measured: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Acceptability of urine pregnancy test Check Top by patients.
Questionnaire
Measured: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbortionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792556
- Sponsor's protocol ID
- 69HCL16_0263
- Acronym
- CHECK-TOP
- Status last verified
- Aug 2018
- First submitted
- 2 Jun 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).
- ClinicalTrials.gov ID
- NCT02792556
- Acronym / sponsor ID
- CHECK-TOP / 69HCL16_0263
- Conditions
- Drug Abortion
- Keywords
- drug abortion, urine pregnancy test, negative predictive value, check Top test, transvaginal ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 7 Jun 2016 (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.
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.
The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.
The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.
In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.
To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.
The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.
This is a monocentric observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient having a drug abortion | – | Device: Urine pregnancy testUrine pregnancy test for adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult women having a drug abortion until 8 weeks of amenorrhea, presenting to the control visit between the 14th and 21th day after drug intake.
Key inclusion criteria (6 listed)
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| Urine pregnancy testUrine pregnancy test Check Top after transvaginal ultrasound | Device | patient having a drug abortion |
Primary outcome
Negative predictive value of urine pregnancy test CHECK TOP
Time frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Negative predictive value of urine pregnancy test CHECK TOP taking as reference transvaginal ultrasound. A negative result at transvaginal ultrasound will be defined as the absence of ongoing pregnancy. An ongoing pregnancy is characterized by the presence of gestational sac, yolk sac and/or embryo with cardiac activity. A positive result will be retained only in case of ongoing pregnancy. Check Top test will be considered as negative if only one colored line appears in the control window, without any line in the result window. It will be considered as positive if two colored lines are present in the result window, corresponding to a β-HCG level > 1000 IU/ml.
4 secondary outcomes
Positive predictive value of urine pregnancy test Check Top
Time frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Sensibility of urine pregnancy test Check Top
Time frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Specificity of urine pregnancy test Check Top
Time frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Acceptability of urine pregnancy test Check Top by patients.
Time frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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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 Drug Abortion, run by Hospices Civils de Lyon 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 6 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 9 Aug 2018. 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 Corine REBELLE, MD (+33 4 72 07 16 63, corine.rebelle@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value of urine pregnancy test CHECK TOP (time frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)). 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 9 Aug 2018.