<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/NCT02246114</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000370</org_study_id>
    <nct_id>NCT02246114</nct_id>
  </id_info>
  <brief_title>Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women</brief_title>
  <official_title>Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant&#xD;
      women. Investigators hypothesize that more regular self-monitoring, text messages and&#xD;
      feedback as provided by home carbon monoxide monitoring device combined with medical feedback&#xD;
      on results will reduce smoking during pregnancy compared to only receiving text message and&#xD;
      no self-monitoring by home monitoring device and no feedback by home carbon monoxide&#xD;
      monitoring device . The periconceptual period is a life period, where given the immediacy of&#xD;
      the fetus and future child, a pregnant woman is willing to try and modify potentially harmful&#xD;
      behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease&#xD;
      and cancer risk, has proven remarkably difficult in traditional medical practice settings,&#xD;
      and successful medical trials have been costly and labor intensive. This proposal aims to&#xD;
      utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation&#xD;
      among pregnant women who smoke. Investigators hypothesize that women who have access to a&#xD;
      self-monitoring device more frequently (i.e., at home) and receive feedback about their&#xD;
      carbon monoxide level will have greater reductions in smoking as determined by declining&#xD;
      serum cotinine levels over the course of the study compared to women who do not have access&#xD;
      to a self-monitoring device and do not receive feedback about their carbon monoxide level,&#xD;
      but only receive text messages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of Recruitment&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome of Serum Cotinine Levels</measure>
    <time_frame>1 year</time_frame>
    <description>The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Pregnancy</condition>
  <condition>Smoking</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>no CO monitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Not given a piCO+ Smokerlyzer® monitor, will receive daily text messages.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CO monitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Given a piCO+ Smokerlyzer® monitor, will receive daily text messages, will receive feedback about the relative level of carbon monoxide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>piCO+ Smokerlyzer® monitor</intervention_name>
    <arm_group_label>CO monitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text messages</intervention_name>
    <arm_group_label>CO monitor</arm_group_label>
    <arm_group_label>no CO monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women 18-40 years old&#xD;
&#xD;
          -  Participants will be pregnant women estimated to be between 6 and 20 weeks into their&#xD;
             pregnancy&#xD;
&#xD;
          -  Pregnant women have smoked at least at least one cigarette in the prior 7 days&#xD;
&#xD;
          -  Own a smartphone capable of delivering and receiving text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Project materials and text messages are in English, potential participants will be&#xD;
             excluded if they cannot read English and if there are concerns about the ability to&#xD;
             comprehend or comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard S Legro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MS Hershey Medical Center, Penn State College of Medicine</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>September 29, 2016</results_first_submitted>
  <results_first_submitted_qc>November 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 16, 2017</results_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Richard S. Legro, M.D.</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynecology and Public Health Sciences</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Smoking</keyword>
  <keyword>Smoking cessation</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm A</title>
          <description>no CO monitor</description>
        </group>
        <group group_id="P2">
          <title>Arm B</title>
          <description>CO monitor</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>miscarriage</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm A</title>
          <description>no CO monitor</description>
        </group>
        <group group_id="B2">
          <title>Arm B</title>
          <description>CO monitor</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" lower_limit="32" upper_limit="32"/>
                    <measurement group_id="B3" value="32" lower_limit="32" upper_limit="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Outcome of Serum Cotinine Levels</title>
        <description>The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.</description>
        <time_frame>1 year</time_frame>
        <population>Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>no CO monitor</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>CO monitor</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Outcome of Serum Cotinine Levels</title>
          <description>The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.</description>
          <population>Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Arm A (no CO Monitor)</title>
          <description>no CO monitor</description>
        </group>
        <group group_id="E2">
          <title>Arm B (CO Monitor)</title>
          <description>CO monitor</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>The study closed early due to lack of recruitment. Only 1 subject enrolled in the study and she terminated after the baseline visit due to a miscarriage at 9 weeks. Therefore no analysis has been performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Richard S. Legro, M.D.</name_or_title>
      <organization>The Milton S. Hershey Medical Center</organization>
      <phone>717-531-6210</phone>
      <email>rsl1@psu.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/NCT02246114
org study id: STUDY00000370
nct id: NCT02246114
lead sponsor: 
collaborator: 
has dmc: No
Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant
      women. Investigators hypothesize that more regular self-monitoring, text messages and
      feedback as provided by home carbon monoxide monitoring device combined with medical feedback
      on results will reduce smoking during pregnancy compared to only receiving text message and
      no self-monitoring by home monitoring device and no feedback by home carbon monoxide
      monitoring device . The periconceptual period is a life period, where given the immediacy of
      the fetus and future child, a pregnant woman is willing to try and modify potentially harmful
      behaviors.
Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease
      and cancer risk, has proven remarkably difficult in traditional medical practice settings,
      and successful medical trials have been costly and labor intensive. This proposal aims to
      utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation
      among pregnant women who smoke. Investigators hypothesize that women who have access to a
      self-monitoring device more frequently (i.e., at home) and receive feedback about their
      carbon monoxide level will have greater reductions in smoking as determined by declining
      serum cotinine levels over the course of the study compared to women who do not have access
      to a self-monitoring device and do not receive feedback about their carbon monoxide level,
      but only receive text messages.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Outcome of Serum Cotinine Levels
time frame: 1 year
description: The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.
arm group label: no CO monitor
arm group type: Experimental
description: Not given a piCO+ Smokerlyzer® monitor, will receive daily text messages.
arm group label: CO monitor
arm group type: Experimental
description: Given a piCO+ Smokerlyzer® monitor, will receive daily text messages, will receive feedback about the relative level of carbon monoxide.
intervention type: Device
intervention name: piCO+ Smokerlyzer® monitor
arm group label: CO monitor
intervention type: Other
intervention name: Text messages
arm group label: CO monitor
arm group label: no CO monitor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard S Legro, MD
role: Principal Investigator
affiliation: Penn State College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Richard S. Legro, M.D.
investigator title: Professor of Obstetrics and Gynecology and Public Health Sciences
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study closed early due to lack of recruitment. Only 1 subject enrolled in the study and she terminated after the baseline visit due to a miscarriage at 9 weeks. Therefore no analysis has been performed.
point of contact: 