xml: <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/NCT05977686</url>
    </required_header>
    <id_info>
      <org_study_id>NCR234874</org_study_id>
      <nct_id>NCT05977686</nct_id>
    </id_info>
    <brief_title>Hemoglobin Testing in Pregnant Patients</brief_title>
    <acronym>Prosp Anemia</acronym>
    <official_title>Point-of-Care Hemoglobin Testing in Pregnant Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>George Washington University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>George Washington University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Our project is a prospective observational study aimed to assess and to validate the use of&#xD;
        point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the&#xD;
        potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource&#xD;
        settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3)&#xD;
        provide immediate results for real-time patient counseling and intervention. However, to&#xD;
        date, point-of-care hemoglobin testing devices have not yet been studied for use in an&#xD;
        ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter,&#xD;
        manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's&#xD;
        finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a&#xD;
        minimally-invasive device that relies on the finger prick method to get a capillary&#xD;
        hemoglobin measurement. Participants in this study will be approached at the Obstetrics and&#xD;
        Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin&#xD;
        measurements will be assessed using the non-invasive Masimo device along with&#xD;
        minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture&#xD;
        hemoglobin testing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a prospective, observational study for which we aim to recruit 200 patients over&#xD;
        the study period. We will approach the patients at one of the MFA Obstetrics and Gynecology&#xD;
        clinics. Once consented, they will be approached at least two time-points during their&#xD;
        antenatal care as below:&#xD;
  &#xD;
          1. OB new/ first prenatal visit (usually between 12-18 weeks of gestation)&#xD;
  &#xD;
          2. OB return visit (usually between 24-28 weeks of gestation)&#xD;
  &#xD;
        We may need to get more Hb time-points readings (up to five readings) if the patient will be&#xD;
        diagnosed with anemia at any of the previously mentioned visits or will be scheduled to have&#xD;
        more blood draws during the prenatal care period. At each time-point visit, we plan to talk&#xD;
        with the provider of the patient about the study. Then we will discuss the study protocol and&#xD;
        the recruitment process with the patient. If the patient consents, we will coordinate with&#xD;
        the lab personnel the exact time of the routinely ordered blood draw (as a part of the&#xD;
        subject's antenatal care) to determine the appropriate time to get the Hb readings using the&#xD;
        devices (preferrably, right before the venipuncture). To obtain the readings, a study reseach&#xD;
        coordinator will apply a disposable probe (Rainbow R1 25 adult adhesive sensor) connected to&#xD;
        a Radical-7 co-oximeter sensor on the ring finger of the same arm of the venipuncture,&#xD;
        shielded by an opaque covering to eliminate intereference from ambient light to obtain the&#xD;
        SpHb reading. In addition, during in the same setting, we will ask for a finger prick&#xD;
        capillary sample to get the Hemocue Hb reading as well.(the same side will be used). Both&#xD;
        readings will be tabulated in a case report form and the standard lab hemoglobin reading will&#xD;
        be added to them once received. This is how we can validate the performance of the Masimo and&#xD;
        the Hemocue devices with the routine lab test results. Additionally, we will collect&#xD;
        demographics, procedure-specific and some antenatal-care variables including vitals,&#xD;
        gestational age and the exact date and time of the records at each time point visit, using a&#xD;
        well-structured case report form.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Accuracy of the devices in all obstetric patients</measure>
      <time_frame>2024</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Ability of point-of-care hemoglobin testing devices to detect anemia (Hemoglobin less than 11 mg/dL) or severe anemia (Hemoglobin less than 9 mg/dL).</measure>
      <time_frame>2024</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Subgroup analysis: by gestational age categories presence or absence of anemia as defined by the gold standard venipuncture</measure>
      <time_frame>2024</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient perception of testing methods</measure>
      <time_frame>2024</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Post Partum Hemorrhage</condition>
    <condition>Anemia of Pregnancy</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Masimo Root Radical 7 Pulse CO-Oximeter</intervention_name>
      <description>The Masimo device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value.</description>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HemoCue Hb 801</intervention_name>
      <description>The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant women ages 18-50 years old&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women ages 18-50 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and&#xD;
               hemoglobin synthesis disorders (quantitative defects such as thalassemia)&#xD;
  &#xD;
            -  Patients with peripheral vascular diseases and skin conditions that affect blood&#xD;
               vessels in the digit&#xD;
  &#xD;
            -  Patients with hyperbilirubinemia&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Homa Ahmadzia, MD/MPH</last_name>
      <phone>7036226524</phone>
      <email>hahmadzia@mfa.gwu.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</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>Postpartum Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977686
  org study id: NCR234874
  nct id: NCT05977686
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Our project is a prospective observational study aimed to assess and to validate the use of
        point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the
        potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource
        settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3)
        provide immediate results for real-time patient counseling and intervention. However, to
        date, point-of-care hemoglobin testing devices have not yet been studied for use in an
        ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter,
        manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's
        finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a
        minimally-invasive device that relies on the finger prick method to get a capillary
        hemoglobin measurement. Participants in this study will be approached at the Obstetrics and
        Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin
        measurements will be assessed using the non-invasive Masimo device along with
        minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture
        hemoglobin testing.
  This will be a prospective, observational study for which we aim to recruit 200 patients over
        the study period. We will approach the patients at one of the MFA Obstetrics and Gynecology
        clinics. Once consented, they will be approached at least two time-points during their
        antenatal care as below:
  
          1. OB new/ first prenatal visit (usually between 12-18 weeks of gestation)
  
          2. OB return visit (usually between 24-28 weeks of gestation)
  
        We may need to get more Hb time-points readings (up to five readings) if the patient will be
        diagnosed with anemia at any of the previously mentioned visits or will be scheduled to have
        more blood draws during the prenatal care period. At each time-point visit, we plan to talk
        with the provider of the patient about the study. Then we will discuss the study protocol and
        the recruitment process with the patient. If the patient consents, we will coordinate with
        the lab personnel the exact time of the routinely ordered blood draw (as a part of the
        subject's antenatal care) to determine the appropriate time to get the Hb readings using the
        devices (preferrably, right before the venipuncture). To obtain the readings, a study reseach
        coordinator will apply a disposable probe (Rainbow R1 25 adult adhesive sensor) connected to
        a Radical-7 co-oximeter sensor on the ring finger of the same arm of the venipuncture,
        shielded by an opaque covering to eliminate intereference from ambient light to obtain the
        SpHb reading. In addition, during in the same setting, we will ask for a finger prick
        capillary sample to get the Hemocue Hb reading as well.(the same side will be used). Both
        readings will be tabulated in a case report form and the standard lab hemoglobin reading will
        be added to them once received. This is how we can validate the performance of the Masimo and
        the Hemocue devices with the routine lab test results. Additionally, we will collect
        demographics, procedure-specific and some antenatal-care variables including vitals,
        gestational age and the exact date and time of the records at each time point visit, using a
        well-structured case report form.
  observational model: Cohort
  time perspective: Prospective
  measure: Accuracy of the devices in all obstetric patients
  time frame: 2024
  measure: Ability of point-of-care hemoglobin testing devices to detect anemia (Hemoglobin less than 11 mg/dL) or severe anemia (Hemoglobin less than 9 mg/dL).
  time frame: 2024
  measure: Subgroup analysis: by gestational age categories presence or absence of anemia as defined by the gold standard venipuncture
  time frame: 2024
  measure: Patient perception of testing methods
  time frame: 2024
  intervention type: Device
  intervention name: Masimo Root Radical 7 Pulse CO-Oximeter
  description: The Masimo device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value.
  intervention type: Device
  intervention name: HemoCue Hb 801
  description: The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Homa Ahmadzia, MD/MPH
  phone: 7036226524
  email: hahmadzia@mfa.gwu.edu
  responsible party type: Sponsor
  mesh term: Postpartum Hemorrhage
  mesh term: Hemorrhage