<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250884</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3038</org_study_id>
    <nct_id>NCT03250884</nct_id>
  </id_info>
  <brief_title>Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.</brief_title>
  <official_title>Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to&#xD;
      improve the medical care of patients in emergency room.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most current gynecological consultations in emergency unit first lead to a pregnancy&#xD;
      diagnostic test. The gold standard used is the diagnostic test based on determination of the&#xD;
      β-human chorionic gonadotropin concentration. But this assay need time and expect women to&#xD;
      wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A&#xD;
      62-patients study showed that results obtained with the rapid test were correlated with&#xD;
      results obtained with the test based on determination of the β-human chorionic gonadotropin&#xD;
      concentration.&#xD;
&#xD;
      The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic&#xD;
      test realized in emergency room, in comparison with the blood determination of the β-human&#xD;
      chorionic gonadotropin concentration which is only tested in medical laboratory. A little&#xD;
      amount of total blood sample used for gold standard test will be used to assess sensibility,&#xD;
      specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waiting time in emergency unit for patients</measure>
    <time_frame>6 months</time_frame>
    <description>Waiting time in emergency unit for patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of blood tests avoided with the rapid pregnancy diagnostic test</measure>
    <time_frame>6 months</time_frame>
    <description>Amount of blood tests avoided with the rapid pregnancy diagnostic test</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Diagnostic</condition>
  <condition>Emergencies</condition>
  <condition>Pelvic Pain</condition>
  <condition>Metrorrhagia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult women who come in emergency unit to consult for metrorrhagia and/or pelvic pains and&#xD;
        who need a diagnostic test using the β-human chorionic gonadotropin blood test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult women who are in genital activity&#xD;
&#xD;
          -  Women who are in emergency unit to consult for metrorrhagia and/or pelvic pains.&#xD;
&#xD;
          -  Lack of intrauterine gestational sac determined using endo-vaginal ultrasound&#xD;
&#xD;
          -  Women who need a diagnostic test using the β-human chorionic gonadotropin blood test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood&#xD;
             test.&#xD;
&#xD;
          -  Patients included in an ovarian stimulation program for infertility&#xD;
&#xD;
          -  Ectopic gestational sac in which there is an embryo with a cardiac activity determined&#xD;
             with ultrasound.&#xD;
&#xD;
          -  Patient objecting to participate in the study&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Persons subject to major legal protection (safeguarding justice, guardianship,&#xD;
             trusteeship), persons deprived of liberty.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnancy test</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Lavoué, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes university hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metrorrhagia</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250884
org study id: 35RC16_3038
nct id: NCT03250884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: 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.
time frame: 6 months
description: 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.
measure: Waiting time in emergency unit for patients
time frame: 6 months
description: Waiting time in emergency unit for patients
measure: Amount of blood tests avoided with the rapid pregnancy diagnostic test
time frame: 6 months
description: Amount of blood tests avoided with the rapid pregnancy diagnostic test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnancy test
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Vincent Lavoué, Pr
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Metrorrhagia
mesh term: Emergencies
mesh term: Pelvic Pain