Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).
NCT ID: NCT02792556
Last Updated: 2018-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2016-09-30
2018-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Urine pregnancy test
Urine pregnancy test Check Top after transvaginal ultrasound
Interventions
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Urine pregnancy test
Urine pregnancy test Check Top after transvaginal ultrasound
Eligibility Criteria
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Inclusion Criteria
* 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
* Ineligible patient to drug abortion
* Patient practicing a surgical abortion
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL16_0263
Identifier Type: -
Identifier Source: org_study_id
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