Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).
CHECK-TOP
Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).
1 other identifier
observational
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedAugust 9, 2018
August 1, 2018
2 years
June 2, 2016
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Sensibility of urine pregnancy test Check Top
During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Specificity of urine pregnancy test Check Top
During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Acceptability of urine pregnancy test Check Top by patients.
During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21)
Study Arms (1)
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.
Interventions
Urine pregnancy test Check Top after transvaginal ultrasound
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Women \<18 years
- Ineligible patient to drug abortion
- Patient practicing a surgical abortion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 7, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
August 9, 2018
Record last verified: 2018-08