|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02792556 |
|
Date of registration:
|
02/06/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).
CHECK-TOP |
|
Scientific title:
|
Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP). |
|
Date of first enrolment:
|
September 2016 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Unknown status |
|
URL:
|
https://clinicaltrials.gov/show/NCT02792556 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Corine REBELLE, MD |
|
Address:
|
|
|
Telephone:
|
+33 4 72 07 16 63 |
|
Email:
|
corine.rebelle@chu-lyon.fr |
|
Affiliation:
|
|
|
|
Name:
|
Corinne REBELLE |
|
Address:
|
|
|
Telephone:
|
+33 4 72 07 16 63 |
|
Email:
|
corine.rebelle@chu-lyon.fr |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
- Inclusion Criteria:
- 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
- Exclusion Criteria:
- Women <18 years
- Ineligible patient to drug abortion
- Patient practicing a surgical abortion
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Drug Abortion
|
|
Intervention(s)
|
|
Device: Urine pregnancy test
|
|
Primary Outcome(s)
|
|
Negative predictive value of urine pregnancy test CHECK TOP
[Time Frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)]
|
|
Secondary Outcome(s)
|
|
Positive predictive value 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)]
|
|
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)]
|
|
Secondary ID(s)
|
|
69HCL16_0263
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|