Clincosm LogoSign in Get a demo

Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03250884
Collaborator
(none)
200
Enrollment
1
Location
15
Actual Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The most current gynecological consultations in emergency unit first lead to a pregnancy diagnostic test. The gold standard used is the diagnostic test based on determination of the β-human chorionic gonadotropin concentration. But this assay need time and expect women to wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A 62-patients study showed that results obtained with the rapid test were correlated with results obtained with the test based on determination of the β-human chorionic gonadotropin concentration.

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
    Actual Study Start Date :
    Aug 30, 2016
    Actual Primary Completion Date :
    Dec 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration. [6 months]

      Number of diagnostic of pregnancy with the rapid pregnancy diagnostic test in comparison with the number of diagnostic of pregnancy with the blood determination of the β-human chorionic gonadotropin concentration.

    Secondary Outcome Measures

    1. Waiting time in emergency unit for patients [6 months]

      Waiting time in emergency unit for patients

    2. Amount of blood tests avoided with the rapid pregnancy diagnostic test [6 months]

      Amount of blood tests avoided with the rapid pregnancy diagnostic test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult women who are in genital activity

    • 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:

    • Previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood test.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rennes university hospital Rennes France 35033

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Vincent Lavoué, Pr, Rennes University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03250884
    Other Study ID Numbers:
    • 35RC16_3038
    First Posted:
    Aug 16, 2017
    Last Update Posted:
    Apr 17, 2018
    Last Verified:
    Aug 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metrorrhagia
    Emergencies
    Pelvic Pain

    Study Results

    No Results Posted as of Apr 17, 2018