<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/NCT02256995</url>
  </required_header>
  <id_info>
    <org_study_id>MATBANG2014</org_study_id>
    <nct_id>NCT02256995</nct_id>
  </id_info>
  <brief_title>uChek Pilot Study for Urinalysis in the Antenatal Care Setting</brief_title>
  <acronym>uChekBangla</acronym>
  <official_title>A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maternova Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck for Mothers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HOPE Foundation for Women and Children of Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maternova Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective observational study to test the feasibility of smartphone enabled uChek&#xD;
      urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in&#xD;
      urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess&#xD;
      attitudes of clinicians towards uChek as a new technology for urinalysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</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>Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting</measure>
    <time_frame>6 months</time_frame>
    <description>1. Test the feasibility of using the uChek urinalysis device to detect biomarkers of preeclampsia/eclampsia at over 22 weeks of gestation as compared to using the sites' current urinalysis method. A correlation analysis of the rate of detection of protein in urine between the uChek and the standard visual dipstick test using the quantitative results from the visual dipstick test and uChek results collected at each of three ANC visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC</measure>
    <time_frame>6 months</time_frame>
    <description>Assess impressions, preferences and attitudes of the clinicians towards the uChek as a tool for urinalysis in antenatal care. A quantitative analysis of questionnaire responses about the usability of the device, including but not limited to:&#xD;
% agree or strongly agree that the uChek is an accurate urinalysis device&#xD;
% reporting that they agree or strongly agree that uChek is easier to use than current method of urinalysis&#xD;
% reporting that they agree or strongly agree that uChek is a suitable technology for a low resource setting</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility of using uChek for expanded urinalysis panel in ANC</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the feasibility of tracking additional biomarkers of conditions affecting pregnant women using urinalysis via the uChek device(glucose for gestational diabetes, nitrites for urinary tract infection, presence of blood, microalbumin for risk of preterm birth, etc.). A quantitative analysis of results of tests for additional biomarkers, detected with the uChek, of conditions affecting pregnant women.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">375</enrollment>
  <condition>Preeclampsia</condition>
  <condition>Eclampsia</condition>
  <condition>Pregnancy</condition>
  <condition>Proteinuria</condition>
  <arm_group>
    <arm_group_label>Pregnant Women (&gt;22 weeks gestation)</arm_group_label>
    <description>Biomarkers tracked over 3 antenatal care visits via standard of care (dipstick, manually/visually assessed) and via uChek (automated assessment via computer application)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>uChek</intervention_name>
    <description>The uChek TM urine analyzer is a semi-automated urinalysis system, installed as an application on a smartphone. It makes use of a smartphone's camera to automatically read urine dipsticks.</description>
    <arm_group_label>Pregnant Women (&gt;22 weeks gestation)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        There are two unique subject populations in this study. One group consists of pregnant&#xD;
        women whose urine will be analyzed- hereafter referred to as the Patient Participants. The&#xD;
        second group is a cohort of medical professionals who will answer a questionnaire about the&#xD;
        usability of the device, relating to the second objective, hereafter referred to as the&#xD;
        Medical Staff Participants. The following parameters have been answered in reference to the&#xD;
        Patient Participants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till&#xD;
             delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study participant is unwilling to take part in study or participants with pathological&#xD;
             conditions that restrict them from providing a urine sample without catheterization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janardana Sharma, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hope Bangladesh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meg E Wirth</last_name>
    <phone>4012286294</phone>
    <email>mwirth@maternova.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Allyson E Cote</last_name>
    <email>allysonecote@maternova.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hope Hospital for Women and Children</name>
      <address>
        <city>Cox's Bazar</city>
        <zip>4700</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Preeclampsia</keyword>
  <keyword>Eclampsia</keyword>
  <keyword>Proteinuria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Proteinuria</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 26, 2016</submitted>
    <returned>March 28, 2016</returned>
  </pending_results>
  <!-- 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/NCT02256995
org study id: MATBANG2014
nct id: NCT02256995
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
A prospective observational study to test the feasibility of smartphone enabled uChek
      urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in
      urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess
      attitudes of clinicians towards uChek as a new technology for urinalysis.
observational model: Cohort
time perspective: Prospective
measure: Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting
time frame: 6 months
description: 1. Test the feasibility of using the uChek urinalysis device to detect biomarkers of preeclampsia/eclampsia at over 22 weeks of gestation as compared to using the sites' current urinalysis method. A correlation analysis of the rate of detection of protein in urine between the uChek and the standard visual dipstick test using the quantitative results from the visual dipstick test and uChek results collected at each of three ANC visits.
measure: Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC
time frame: 6 months
description: Assess impressions, preferences and attitudes of the clinicians towards the uChek as a tool for urinalysis in antenatal care. A quantitative analysis of questionnaire responses about the usability of the device, including but not limited to:
% agree or strongly agree that the uChek is an accurate urinalysis device
% reporting that they agree or strongly agree that uChek is easier to use than current method of urinalysis
% reporting that they agree or strongly agree that uChek is a suitable technology for a low resource setting
measure: Feasibility of using uChek for expanded urinalysis panel in ANC
time frame: 6 months
description: To assess the feasibility of tracking additional biomarkers of conditions affecting pregnant women using urinalysis via the uChek device(glucose for gestational diabetes, nitrites for urinary tract infection, presence of blood, microalbumin for risk of preterm birth, etc.). A quantitative analysis of results of tests for additional biomarkers, detected with the uChek, of conditions affecting pregnant women.
arm group label: Pregnant Women (>22 weeks gestation)
description: Biomarkers tracked over 3 antenatal care visits via standard of care (dipstick, manually/visually assessed) and via uChek (automated assessment via computer application)
intervention type: Device
intervention name: uChek
description: The uChek TM urine analyzer is a semi-automated urinalysis system, installed as an application on a smartphone. It makes use of a smartphone's camera to automatically read urine dipsticks.
arm group label: Pregnant Women (>22 weeks gestation)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janardana Sharma, MD
role: Study Director
affiliation: Hope Bangladesh
last name: Meg E Wirth
phone: 4012286294
email: mwirth@maternova.net
last name: Allyson E Cote
email: allysonecote@maternova.net
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Eclampsia
mesh term: Proteinuria
submitted: February 26, 2016
returned: March 28, 2016