Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
NCT ID: NCT03250884
Last Updated: 2018-04-17
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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COMPLETED
200 participants
OBSERVATIONAL
2016-08-30
2017-12-31
Brief Summary
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Detailed Description
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The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic test realized in emergency room, in comparison with the blood determination of the β-human chorionic gonadotropin concentration which is only tested in medical laboratory. A little amount of total blood sample used for gold standard test will be used to assess sensibility, specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Women who are in emergency unit to consult for metrorrhagia and/or pelvic pains.
* Lack of intrauterine gestational sac determined using endo-vaginal ultrasound
* Women who need a diagnostic test using the β-human chorionic gonadotropin blood test.
Exclusion Criteria
* Patients included in an ovarian stimulation program for infertility
* Ectopic gestational sac in which there is an embryo with a cardiac activity determined with ultrasound.
* Patient objecting to participate in the study
* Minor
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
18 Years
60 Years
FEMALE
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Vincent Lavoué, Pr
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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Rennes university hospital
Rennes, , France
Countries
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Other Identifiers
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35RC16_3038
Identifier Type: -
Identifier Source: org_study_id
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