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Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP). (CHECK-TOP)

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ClinicalTrials.gov Identifier: NCT02792556
Recruitment Status : Unknown
Verified August 2018 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : June 7, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment
Drug Abortion Device: Urine pregnancy test

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: Urine pregnancy test
Urine pregnancy test Check Top after transvaginal ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Positive predictive value of urine pregnancy test Check Top [ Time Frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) ]
    Positive predictive value of urine pregnancy test Check Top compared to transvaginal ultrasound.

  2. Sensibility 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 compared to transvaginal ultrasound.

  3. Specificity 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 compared to transvaginal ultrasound.

  4. Acceptability of urine pregnancy test Check Top by patients. [ Time Frame: During control visit post drug abortion, after transvaginal ultrasound (at day14 or day21) ]
    Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792556


Contacts
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Contact: Corine REBELLE, MD +33 4 72 07 16 63 corine.rebelle@chu-lyon.fr
Contact: Mahé RAFFIN +33 4.26.73.27.38 mahe.raffin@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Hôpital de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Corinne REBELLE    +33 4 72 07 16 63    corine.rebelle@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02792556    
Other Study ID Numbers: 69HCL16_0263
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Keywords provided by Hospices Civils de Lyon:
drug abortion
urine pregnancy test
negative predictive value
check Top test
transvaginal ultrasound