<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/NCT02258256</url>
  </required_header>
  <id_info>
    <org_study_id>14-082F-C</org_study_id>
    <secondary_id>(COMREC) P.04/14/1548</secondary_id>
    <nct_id>NCT02258256</nct_id>
  </id_info>
  <brief_title>Pilot Assessment of an Auto Blood Pressure Monitor</brief_title>
  <official_title>Pilot Clinical Assessment of the Diagnostic Capability, Usability, and Function of an Automatic Blood Pressure Monitor for Use in the Diagnosis and Management of Pre-eclampsia in a Low-resource Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Marsh Rice University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malawi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>William Marsh Rice University</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 purpose of the study is to help make a lower cost automatic blood pressure monitor device&#xD;
      for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood&#xD;
      pressure monitoring is limited or not available. The study will compare this low cost device&#xD;
      to a commercially available system used for pre-eclamptic women in many United States&#xD;
      hospitals that the investigators will be bringing to Malawi as a part of this study.&#xD;
&#xD;
      The team hopes to show that this lower cost blood pressure machine works well and can help&#xD;
      women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to&#xD;
      use.&#xD;
&#xD;
      20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen&#xD;
      Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the&#xD;
      subject and the commercially available cuff on the opposite arm. A trained research assistant&#xD;
      and the nurse will record the blood pressure measurements and document any alarm indications&#xD;
      made by each device. Blood pressure measurements will continue until monitoring is no longer&#xD;
      clinically prescribed.&#xD;
&#xD;
      The results of this study will help researchers understand the performance and usability of&#xD;
      this device in Malawi and help decide if any design changes are needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research team at Rice University has developed Sphygmo, an automatic blood pressure&#xD;
      monitor to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women,&#xD;
      particularly in low-resource settings where current blood pressure monitoring is limited.&#xD;
      This study aims to evaluate the capabilities of the device in the setting for which it was&#xD;
      designed - a low-resource hospital.&#xD;
&#xD;
      This study will compare the Sphygmo device to a commercially available automatic blood&#xD;
      pressure monitor that is used in pre-eclamptic women. The main objective of this study is to&#xD;
      determine whether the Sphygmo device correctly identifies instances where blood pressure&#xD;
      measurement meets the diagnostic criteria for mild or severe pre-eclampsia during monitoring&#xD;
      of at-risk mothers. Additionally, this study aims to understand the frequency and type of any&#xD;
      complications associated with use of the Sphygmo in a resource-limited clinical setting.&#xD;
&#xD;
      The study will include 20 eligible and consenting women at QECH who are clinically identified&#xD;
      as at-risk for pre-eclampsia or have already been diagnosed with pre-eclampsia by their&#xD;
      doctors. All participants will undergo the same protocol (monitoring with both Sphygmo and&#xD;
      the commercially available device). First, a nurse will fit a Sphygmo device cuff on one arm&#xD;
      of the subject and the commercially available device cuff on the opposite arm. A trained&#xD;
      research assistant will be continuously on hand to assist the nurse in the device setup and&#xD;
      record the blood pressure measurements and any alarm indications made by each device. Blood&#xD;
      pressure measurements by Sphygmo and the commercially available device will continue until&#xD;
      monitoring is no longer clinically prescribed. In addition, blood pressure will be taken via&#xD;
      clinical auscultatory measurement with a stethoscope and aneroid gauge at regular intervals.&#xD;
      This third method will help us confirm the accuracy of the two devices. All clinical&#xD;
      decisions will be made according to the commercially available device's measurements.&#xD;
&#xD;
      The key results of the study will be the ability of the Sphygmo device to identify blood&#xD;
      pressure levels corresponding to mild and severe pre-eclampsia. Additionally, the&#xD;
      investigators will document any user errors or device malfunction. These results will provide&#xD;
      information on the performance and ease of use of the device and will also alert the research&#xD;
      team of any necessary changes needed for the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pregnant women will have their blood pressure measured by both the experimental device (Sphygmo ) and the gold-standard, commercial device (GE Dinamap Procare).</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.</measure>
    <time_frame>Measured during a single study visit, up to 24-72 hours.</time_frame>
    <description>Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Pre Eclampsia</condition>
  <arm_group>
    <arm_group_label>Sphygmo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sphygmo</intervention_name>
    <description>A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals</description>
    <arm_group_label>Sphygmo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who have been identified as at-risk for pre-eclampsia or have been diagnosed&#xD;
             with pre-eclampsia during a visit to QECH.&#xD;
&#xD;
          -  Women who have been clinically identified to benefit from continuous blood pressure&#xD;
             monitoring.&#xD;
&#xD;
          -  Women ages 18 or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who have already developed eclampsia.&#xD;
&#xD;
          -  Women under age 18.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca R Richards-Kortum, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Marsh Rice University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald Mataya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malawi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Central Hospital</name>
      <address>
        <city>Blantyre</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <reference>
    <citation>Magee LA, Abalos E, von Dadelszen P, Sibai B, Easterling T, Walkinshaw S; CHIPS Study Group. How to manage hypertension in pregnancy effectively. Br J Clin Pharmacol. 2011 Sep;72(3):394-401. doi: 10.1111/j.1365-2125.2011.04002.x.</citation>
    <PMID>21545480</PMID>
  </reference>
  <reference>
    <citation>Wagner LK. Diagnosis and management of preeclampsia. Am Fam Physician. 2004 Dec 15;70(12):2317-24.</citation>
    <PMID>15617295</PMID>
  </reference>
  <reference>
    <citation>De Greeff A, Ghosh D, Anthony J, Shennan A. Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia. Hypertens Pregnancy. 2010 Jan;29(2):198-205. doi: 10.3109/10641950902968650.</citation>
    <PMID>20367507</PMID>
  </reference>
  <reference>
    <citation>Turner JA. Diagnosis and management of pre-eclampsia: an update. Int J Womens Health. 2010 Sep 30;2:327-37. doi: 10.2147/IJWH.S8550.</citation>
    <PMID>21151680</PMID>
  </reference>
  <reference>
    <citation>Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. doi: 10.1016/S0140-6736(00)03599-6.</citation>
    <PMID>11213110</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>June 24, 2016</results_first_submitted>
  <results_first_submitted_qc>December 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2018</results_first_posted>
  <last_update_submitted>August 7, 2021</last_update_submitted>
  <last_update_submitted_qc>August 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Marsh Rice University</investigator_affiliation>
    <investigator_full_name>Rebecca Richards-Kortum</investigator_full_name>
    <investigator_title>Stanley C. Moore Professor of Bioengineering</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02258256/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Preeclamptic Women</title>
          <description>All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device&#xD;
Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Preeclamptic Women</title>
          <description>All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device&#xD;
Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" lower_limit="20" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Malawi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.</title>
        <description>Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants</description>
        <time_frame>Measured during a single study visit, up to 24-72 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Preeclamptic Women</title>
            <description>All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device&#xD;
Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.</title>
          <description>Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Mean BP - Sphygmo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.3" spread="31.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Diastolic BP - Sphygmo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.2" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Systolic BP - GE Dinamap</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.8" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Diastolic BP - GE Dinamap</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.9" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over the length of the subject visit (24-72 hours).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Preeclamptic Women</title>
          <description>All subjects are pre-eclamptic women who will have their blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device&#xD;
Sphygmo: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Rebecca Richards-Kortum</name_or_title>
      <organization>Rice 360: Institute for Global Health</organization>
      <phone>713-348-3823</phone>
      <email>rkortum@rice.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02258256
org study id: 14-082F-C
secondary id: (COMREC) P.04/14/1548
nct id: NCT02258256
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to help make a lower cost automatic blood pressure monitor device
      for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood
      pressure monitoring is limited or not available. The study will compare this low cost device
      to a commercially available system used for pre-eclamptic women in many United States
      hospitals that the investigators will be bringing to Malawi as a part of this study.

      The team hopes to show that this lower cost blood pressure machine works well and can help
      women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to
      use.

      20 women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at Queen
      Elizabeth Central Hospital. First, a nurse will fit the test device cuff on one arm of the
      subject and the commercially available cuff on the opposite arm. A trained research assistant
      and the nurse will record the blood pressure measurements and document any alarm indications
      made by each device. Blood pressure measurements will continue until monitoring is no longer
      clinically prescribed.

      The results of this study will help researchers understand the performance and usability of
      this device in Malawi and help decide if any design changes are needed.
The research team at Rice University has developed Sphygmo, an automatic blood pressure
      monitor to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women,
      particularly in low-resource settings where current blood pressure monitoring is limited.
      This study aims to evaluate the capabilities of the device in the setting for which it was
      designed - a low-resource hospital.

      This study will compare the Sphygmo device to a commercially available automatic blood
      pressure monitor that is used in pre-eclamptic women. The main objective of this study is to
      determine whether the Sphygmo device correctly identifies instances where blood pressure
      measurement meets the diagnostic criteria for mild or severe pre-eclampsia during monitoring
      of at-risk mothers. Additionally, this study aims to understand the frequency and type of any
      complications associated with use of the Sphygmo in a resource-limited clinical setting.

      The study will include 20 eligible and consenting women at QECH who are clinically identified
      as at-risk for pre-eclampsia or have already been diagnosed with pre-eclampsia by their
      doctors. All participants will undergo the same protocol (monitoring with both Sphygmo and
      the commercially available device). First, a nurse will fit a Sphygmo device cuff on one arm
      of the subject and the commercially available device cuff on the opposite arm. A trained
      research assistant will be continuously on hand to assist the nurse in the device setup and
      record the blood pressure measurements and any alarm indications made by each device. Blood
      pressure measurements by Sphygmo and the commercially available device will continue until
      monitoring is no longer clinically prescribed. In addition, blood pressure will be taken via
      clinical auscultatory measurement with a stethoscope and aneroid gauge at regular intervals.
      This third method will help us confirm the accuracy of the two devices. All clinical
      decisions will be made according to the commercially available device's measurements.

      The key results of the study will be the ability of the Sphygmo device to identify blood
      pressure levels corresponding to mild and severe pre-eclampsia. Additionally, the
      investigators will document any user errors or device malfunction. These results will provide
      information on the performance and ease of use of the device and will also alert the research
      team of any necessary changes needed for the device.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pregnant women will have their blood pressure measured by both the experimental device (Sphygmo ) and the gold-standard, commercial device (GE Dinamap Procare).
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.
time frame: Measured during a single study visit, up to 24-72 hours.
description: Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants
arm group label: Sphygmo
arm group type: Experimental
description: All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device
intervention type: Device
intervention name: Sphygmo
description: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals
arm group label: Sphygmo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca R Richards-Kortum, PhD
role: Principal Investigator
affiliation: William Marsh Rice University
last name: Ronald Mataya, MD
role: Principal Investigator
affiliation: University of Malawi
facility: 
country: Malawi
citation: Magee LA, Abalos E, von Dadelszen P, Sibai B, Easterling T, Walkinshaw S; CHIPS Study Group. How to manage hypertension in pregnancy effectively. Br J Clin Pharmacol. 2011 Sep;72(3):394-401. doi: 10.1111/j.1365-2125.2011.04002.x.
PMID: 21545480
citation: Wagner LK. Diagnosis and management of preeclampsia. Am Fam Physician. 2004 Dec 15;70(12):2317-24.
PMID: 15617295
citation: De Greeff A, Ghosh D, Anthony J, Shennan A. Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia. Hypertens Pregnancy. 2010 Jan;29(2):198-205. doi: 10.3109/10641950902968650.
PMID: 20367507
citation: Turner JA. Diagnosis and management of pre-eclampsia: an update. Int J Womens Health. 2010 Sep 30;2:327-37. doi: 10.2147/IJWH.S8550.
PMID: 21151680
citation: Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. doi: 10.1016/S0140-6736(00)03599-6.
PMID: 11213110
responsible party type: Principal Investigator
investigator affiliation: William Marsh Rice University
investigator full name: Rebecca Richards-Kortum
investigator title: Stanley C. Moore Professor of Bioengineering
mesh term: Eclampsia
mesh term: Pre-Eclampsia
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 