<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/NCT03024606</url>
  </required_header>
  <id_info>
    <org_study_id>23943</org_study_id>
    <nct_id>NCT03024606</nct_id>
  </id_info>
  <brief_title>Smoking Cessation Intervention in Pregnant Women</brief_title>
  <official_title>Smoking Cessation Following Text Message Intervention in Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose an 18-month, randomized, open-label evaluation of the impact of&#xD;
      texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will&#xD;
      be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of&#xD;
      age, are in the preparation stage of change and willing to set a quit date within 30 days and&#xD;
      before 35 weeks gestation, and have a cellular phone that is capable of receiving text&#xD;
      messages. Patients will be randomized to either the texting group or control group. A&#xD;
      baseline carbon monoxide level will be obtained. The patient, regardless of group, will have&#xD;
      the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem&#xD;
      that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy&#xD;
      patches or bupropion free of charge in 2-week intervals. Patients in the intervention group&#xD;
      will receive text messages focused on smoking cessation and pregnancy. Patients will be seen&#xD;
      on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with&#xD;
      the pharmacist, and complete a carbon monoxide exhalation test. These visits will be&#xD;
      continued until the pharmacotherapy course is complete.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking during pregnancy has been shown to have detrimental effects on both the mother and&#xD;
      the fetus. The perinatal period presents a critical opportunity to educate and support the&#xD;
      mother as she attempts quit. Current studies suggest a median quit rate of only 4.9% in women&#xD;
      receiving usual care (Cognitive Behavioral Therapy, CBT), but a number of studies have&#xD;
      investigated new interventions in addition to usual care to help increase compliance with&#xD;
      smoking cessation. Pharmacological aids such as nicotine replacement therapy (NRT) and&#xD;
      bupropion are recommended as potential options by the American College of Obstetrics and&#xD;
      Gynecology since they are considered safer than continued smoking during pregnancy. Studies&#xD;
      thus far on smoking cessation with the help of electronic devices have demonstrated mixed&#xD;
      results; however, the impact of texting in the pregnant population in combination with CBT&#xD;
      and pharmacological therapy has yet to be assessed.&#xD;
&#xD;
      Smoking during pregnancy has been shown to have detrimental effects on both the mother and&#xD;
      the fetus. Cigarettes contain over 3000 compounds many of which can cause risk to pregnancy.&#xD;
      However, the nicotine and carbon monoxide components are of primary concern. Nicotine&#xD;
      releases epinephrine, which results in a decrease in uterine blood flow and an increase in&#xD;
      uterine resistance. There is also decreased production of fetal nitric oxide resulting in&#xD;
      lower blood flow to the fetus and leading to decreased birth weight, length, and head&#xD;
      circumference compared to non-smokers.&#xD;
&#xD;
      Studies have proven that exposure to tobacco can increase the risk for placental abruption,&#xD;
      placental previa, preterm birth, antenatal death, sudden infant death syndromes,&#xD;
      attention-deficit/hyperactivity disorder and asthma. Compared to children of non-smoking&#xD;
      mothers, children of mothers who smoked during pregnancy had a higher BMI and increased odds&#xD;
      for being overweight at 4-years of age; however, in the children whose mother quit smoking&#xD;
      during pregnancy there was no increased risk of increased BMI or being overweight compared to&#xD;
      the children of non-smoking mothers. According to the data from the 2009 Pregnancy Risk&#xD;
      Assessment and Monitoring System (PRAMS) approximately 12.4% of pregnant women with live&#xD;
      births reported smoking during the last three months of pregnancy (PRAMS). Of the 25% of&#xD;
      women who smoked in the 3 months prior to pregnancy, 52% quit during pregnancy; of those, 44%&#xD;
      relapsed within 6 months after delivery. The perinatal period presents a critical opportunity&#xD;
      to educate and support the mother as she attempts quit.&#xD;
&#xD;
      Current studies evaluating rates of smoking cessation in pregnant women show less than ideal&#xD;
      results. A primary analysis of 12 pooled trials found a median quit rate of 4.9% in women&#xD;
      with usual care. This rate increased to 13.2% in patients that received tailored self-help&#xD;
      intervention.12 To help increase compliance with cessation, studies have investigated new&#xD;
      interventions as part of the usual care provided to pregnant patients that continue to smoke.&#xD;
      One study looked at including a 15-minute video and provider prompting at baseline and one&#xD;
      month. Although a higher percentage of patients in the intervention group had a higher 30-day&#xD;
      abstinence rate at 2-months post baseline, the finding was not significant (26.1% vs 10.5%,&#xD;
      p=0.12) although the study did not discuss if this was an appropriately powered sample size.&#xD;
      Another study looking at the combination of smoking cessation education, physical activity&#xD;
      counseling and supervised exercise found a 25% abstinence rate at 8-months gestation. The use&#xD;
      of NRT has also been studied. One study found that CBT plus NRT verses CBT alone was&#xD;
      effective at 7-weeks (24% vs 8%, p=0.02) and 38-weeks' gestation (18% vs 7%, p=0.04),&#xD;
      unfortunately there was no benefit at 3-months post-partum (20% vs. 14%, p=0.55).&#xD;
&#xD;
      The use of pharmacological aids for smoking cessation is recommended as a potential option by&#xD;
      the American College of Obstetrics and Gynecology. Currently, NRT products and bupropion are&#xD;
      appropriate options during pregnancy and are the most utilized therapy for cessation during&#xD;
      pregnancy. Although classified as pregnancy category-D medication, NRT patches are often used&#xD;
      to assist the pregnant patient in smoking cessation when CBT is not successful. A review&#xD;
      looking at 4-studies that examined pregnancy outcomes after NRT, found a significant decrease&#xD;
      in the risk of preterm delivery and low-birth weight compared to active smokers. NRT is&#xD;
      considered safer than continued smoking since it only provides nicotine whereas smoking&#xD;
      provides nicotine plus over 3000 other chemicals. It has also improved cessation rates near&#xD;
      the quit date compared to CBT in obstetric patients. Similarly, bupropion has improved&#xD;
      cessation rates in non-obstetric patients and has not been associated with malformations or&#xD;
      abnormal pregnancy outcomes.&#xD;
&#xD;
      The transtheoretical stages of change assessment is beneficial to help determine a patient's&#xD;
      readiness to quit. Data has shown that the stages predict preparation for cessation and&#xD;
      successful cessation. In the precontemplative stage, patients are not willing to consider&#xD;
      smoking cessation. The contemplative stage is defined as patients considering smoking&#xD;
      cessation but not ready to set a quit date. Preparation stage occurs when patient is ready to&#xD;
      set a quit date within the next 30 days. In the action stage, patients have been smoke free&#xD;
      for less than six months. Maintenance stage is cessation longer than 6 months. Relapse is&#xD;
      when patients have starting smoking again after being in the action stage. In other obstetric&#xD;
      smoking cessation literature, relapse has been defined as smoking more than 5 cigarettes or&#xD;
      smoking more than 5 times since cessation.&#xD;
&#xD;
      Mobile technology is common place in today's society. According to the 2013 Nielsen report,&#xD;
      94% of all Americans 16 years of age or older use a cellular phone with more than half of&#xD;
      those being smart phones. A total of 96% of phone owners have a data plan included. In 2012,&#xD;
      the average monthly usage included 164.5 calls, 644.1 voice minutes, and 764.2 text messages.&#xD;
      Ownership of cell phones and high tech devices extends to all socioeconomic classes, and the&#xD;
      ease and affordability has made cell phone use common for all races and income brackets. When&#xD;
      looking at text message specifically for race 79% of whites, 85% of Blacks and 87% of&#xD;
      Hispanics report text messaging. When looking at household income 78% of those making &lt; 30K,&#xD;
      80% of those making between 30k-50k, and 88% of those making greater than 50k are active&#xD;
      texters. African Americans are more likely than the general population to own smart phones&#xD;
      (71% vs. 62%) and are 44% more likely than the broader market to create a social media&#xD;
      profile. Over a monthly basis, African Americans also spend 24% more time on their phone ,&#xD;
      12% more time on email, and 10% more time on the internet. Hispanics text the greatest of all&#xD;
      ethnic groups at 943 text messages per month. Based on this data, it is apparent that mobile&#xD;
      phone messaging is a potential convenient and cost-effective way to interact with patients of&#xD;
      all races and income levels.&#xD;
&#xD;
      Results of current studies looking at smoking cessation with the help of computer or other&#xD;
      electronic device are mixed. Several trials have looked at the use of text-messaging based&#xD;
      smoking cessation programs. One randomized controlled pilot trial of 151 daily smokers&#xD;
      interested in quitting found a non-clinically significant difference in cessation rates at 3&#xD;
      months between the intervention and control groups (11% versus 4%), this study was not&#xD;
      powered to detect a statistical difference. A small pilot study evaluating Text2Quit, an&#xD;
      automated, personalized, and interactive program that sends texts and emails over the course&#xD;
      of 3 months, reported liking the program at 2 and 4 weeks after enrollment (91% and 82%,&#xD;
      respectively) and 75% of participants reported reading most or all of the messages sent.&#xD;
      Unfortunately, the majority of participants admitted to smoking at the 4-week visit. The&#xD;
      txt2stop study was a trial of 5800 smokers that were randomized to receive text messages that&#xD;
      were comprised of motivational and behaviour-change support versus the control group who&#xD;
      received text messages unrelated to quitting. At 6-months abstinence was significantly&#xD;
      increased in the intervention group versus the control group (10.7% vs. 4.9%; p&lt;0.0001).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">June 14, 2017</completion_date>
  <primary_completion_date type="Actual">June 14, 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exhaled Carbon Monoxide Levels</measure>
    <time_frame>1 month</time_frame>
    <description>self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>texting group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>text messages focused on smoking cessation and pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No text messages</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>text messages focused on smoking cessation and pregnancy</intervention_name>
    <description>The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.</description>
    <arm_group_label>texting group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a confirmed pregnancy,&#xD;
&#xD;
          -  English speaking,&#xD;
&#xD;
          -  18-55 years of age,&#xD;
&#xD;
          -  Are in the preparation stage of change and willing to set a quit date within 30 days&#xD;
             and before 35 weeks gestation,&#xD;
&#xD;
          -  Have a cellular phone that is capable of receiving text messages, and be willing to&#xD;
             pay for any related fees for testing.&#xD;
&#xD;
          -  Willing and able to commit to the visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational age &gt; 35 weeks at quit date&#xD;
&#xD;
          -  If subjects are in the pre-contemplative or contemplative stages of change or have&#xD;
             already received 30 minute pharmacy education targeted for the quit date in this&#xD;
             pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine J Mathews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <results_first_submitted>June 14, 2017</results_first_submitted>
  <results_first_submitted_qc>October 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 24, 2018</results_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Katherine Mathews, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>December 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03024606/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>23 patient were randomized to the texting group and 26 to the control. However, 9 in the texting group and 10 in the controls did not follow up for any study procedures of data collection, so we do not have data to report on them.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Texting Group</title>
          <description>text messages focused on smoking cessation and pregnancy&#xD;
text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>No text messages</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Texting Group</title>
          <description>text messages focused on smoking cessation and pregnancy&#xD;
text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>No text messages</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="14"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Exhaled Carbon Monoxide Levels</title>
        <description>self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Texting Group</title>
            <description>text messages focused on smoking cessation and pregnancy&#xD;
text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No text messages</description>
          </group>
        </group_list>
        <measure>
          <title>Exhaled Carbon Monoxide Levels</title>
          <description>self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Texting Group</title>
          <description>text messages focused on smoking cessation and pregnancy&#xD;
text messages focused on smoking cessation and pregnancy: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>No text messages</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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </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>
    <limitations_and_caveats>Due to challenges with recruitment and retention, the study was underpowered to detect statistical differences.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Research Nurse</name_or_title>
      <organization>Saint Louis University</organization>
      <phone>314-977-2090</phone>
      <email>jathompson@slu.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/NCT03024606
org study id: 23943
nct id: NCT03024606
lead sponsor: 
has dmc: No
The investigators propose an 18-month, randomized, open-label evaluation of the impact of
      texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will
      be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of
      age, are in the preparation stage of change and willing to set a quit date within 30 days and
      before 35 weeks gestation, and have a cellular phone that is capable of receiving text
      messages. Patients will be randomized to either the texting group or control group. A
      baseline carbon monoxide level will be obtained. The patient, regardless of group, will have
      the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem
      that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy
      patches or bupropion free of charge in 2-week intervals. Patients in the intervention group
      will receive text messages focused on smoking cessation and pregnancy. Patients will be seen
      on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with
      the pharmacist, and complete a carbon monoxide exhalation test. These visits will be
      continued until the pharmacotherapy course is complete.
Smoking during pregnancy has been shown to have detrimental effects on both the mother and
      the fetus. The perinatal period presents a critical opportunity to educate and support the
      mother as she attempts quit. Current studies suggest a median quit rate of only 4.9% in women
      receiving usual care (Cognitive Behavioral Therapy, CBT), but a number of studies have
      investigated new interventions in addition to usual care to help increase compliance with
      smoking cessation. Pharmacological aids such as nicotine replacement therapy (NRT) and
      bupropion are recommended as potential options by the American College of Obstetrics and
      Gynecology since they are considered safer than continued smoking during pregnancy. Studies
      thus far on smoking cessation with the help of electronic devices have demonstrated mixed
      results; however, the impact of texting in the pregnant population in combination with CBT
      and pharmacological therapy has yet to be assessed.

      Smoking during pregnancy has been shown to have detrimental effects on both the mother and
      the fetus. Cigarettes contain over 3000 compounds many of which can cause risk to pregnancy.
      However, the nicotine and carbon monoxide components are of primary concern. Nicotine
      releases epinephrine, which results in a decrease in uterine blood flow and an increase in
      uterine resistance. There is also decreased production of fetal nitric oxide resulting in
      lower blood flow to the fetus and leading to decreased birth weight, length, and head
      circumference compared to non-smokers.

      Studies have proven that exposure to tobacco can increase the risk for placental abruption,
      placental previa, preterm birth, antenatal death, sudden infant death syndromes,
      attention-deficit/hyperactivity disorder and asthma. Compared to children of non-smoking
      mothers, children of mothers who smoked during pregnancy had a higher BMI and increased odds
      for being overweight at 4-years of age; however, in the children whose mother quit smoking
      during pregnancy there was no increased risk of increased BMI or being overweight compared to
      the children of non-smoking mothers. According to the data from the 2009 Pregnancy Risk
      Assessment and Monitoring System (PRAMS) approximately 12.4% of pregnant women with live
      births reported smoking during the last three months of pregnancy (PRAMS). Of the 25% of
      women who smoked in the 3 months prior to pregnancy, 52% quit during pregnancy; of those, 44%
      relapsed within 6 months after delivery. The perinatal period presents a critical opportunity
      to educate and support the mother as she attempts quit.

      Current studies evaluating rates of smoking cessation in pregnant women show less than ideal
      results. A primary analysis of 12 pooled trials found a median quit rate of 4.9% in women
      with usual care. This rate increased to 13.2% in patients that received tailored self-help
      intervention.12 To help increase compliance with cessation, studies have investigated new
      interventions as part of the usual care provided to pregnant patients that continue to smoke.
      One study looked at including a 15-minute video and provider prompting at baseline and one
      month. Although a higher percentage of patients in the intervention group had a higher 30-day
      abstinence rate at 2-months post baseline, the finding was not significant (26.1% vs 10.5%,
      p=0.12) although the study did not discuss if this was an appropriately powered sample size.
      Another study looking at the combination of smoking cessation education, physical activity
      counseling and supervised exercise found a 25% abstinence rate at 8-months gestation. The use
      of NRT has also been studied. One study found that CBT plus NRT verses CBT alone was
      effective at 7-weeks (24% vs 8%, p=0.02) and 38-weeks' gestation (18% vs 7%, p=0.04),
      unfortunately there was no benefit at 3-months post-partum (20% vs. 14%, p=0.55).

      The use of pharmacological aids for smoking cessation is recommended as a potential option by
      the American College of Obstetrics and Gynecology. Currently, NRT products and bupropion are
      appropriate options during pregnancy and are the most utilized therapy for cessation during
      pregnancy. Although classified as pregnancy category-D medication, NRT patches are often used
      to assist the pregnant patient in smoking cessation when CBT is not successful. A review
      looking at 4-studies that examined pregnancy outcomes after NRT, found a significant decrease
      in the risk of preterm delivery and low-birth weight compared to active smokers. NRT is
      considered safer than continued smoking since it only provides nicotine whereas smoking
      provides nicotine plus over 3000 other chemicals. It has also improved cessation rates near
      the quit date compared to CBT in obstetric patients. Similarly, bupropion has improved
      cessation rates in non-obstetric patients and has not been associated with malformations or
      abnormal pregnancy outcomes.

      The transtheoretical stages of change assessment is beneficial to help determine a patient's
      readiness to quit. Data has shown that the stages predict preparation for cessation and
      successful cessation. In the precontemplative stage, patients are not willing to consider
      smoking cessation. The contemplative stage is defined as patients considering smoking
      cessation but not ready to set a quit date. Preparation stage occurs when patient is ready to
      set a quit date within the next 30 days. In the action stage, patients have been smoke free
      for less than six months. Maintenance stage is cessation longer than 6 months. Relapse is
      when patients have starting smoking again after being in the action stage. In other obstetric
      smoking cessation literature, relapse has been defined as smoking more than 5 cigarettes or
      smoking more than 5 times since cessation.

      Mobile technology is common place in today's society. According to the 2013 Nielsen report,
      94% of all Americans 16 years of age or older use a cellular phone with more than half of
      those being smart phones. A total of 96% of phone owners have a data plan included. In 2012,
      the average monthly usage included 164.5 calls, 644.1 voice minutes, and 764.2 text messages.
      Ownership of cell phones and high tech devices extends to all socioeconomic classes, and the
      ease and affordability has made cell phone use common for all races and income brackets. When
      looking at text message specifically for race 79% of whites, 85% of Blacks and 87% of
      Hispanics report text messaging. When looking at household income 78% of those making < 30K,
      80% of those making between 30k-50k, and 88% of those making greater than 50k are active
      texters. African Americans are more likely than the general population to own smart phones
      (71% vs. 62%) and are 44% more likely than the broader market to create a social media
      profile. Over a monthly basis, African Americans also spend 24% more time on their phone ,
      12% more time on email, and 10% more time on the internet. Hispanics text the greatest of all
      ethnic groups at 943 text messages per month. Based on this data, it is apparent that mobile
      phone messaging is a potential convenient and cost-effective way to interact with patients of
      all races and income levels.

      Results of current studies looking at smoking cessation with the help of computer or other
      electronic device are mixed. Several trials have looked at the use of text-messaging based
      smoking cessation programs. One randomized controlled pilot trial of 151 daily smokers
      interested in quitting found a non-clinically significant difference in cessation rates at 3
      months between the intervention and control groups (11% versus 4%), this study was not
      powered to detect a statistical difference. A small pilot study evaluating Text2Quit, an
      automated, personalized, and interactive program that sends texts and emails over the course
      of 3 months, reported liking the program at 2 and 4 weeks after enrollment (91% and 82%,
      respectively) and 75% of participants reported reading most or all of the messages sent.
      Unfortunately, the majority of participants admitted to smoking at the 4-week visit. The
      txt2stop study was a trial of 5800 smokers that were randomized to receive text messages that
      were comprised of motivational and behaviour-change support versus the control group who
      received text messages unrelated to quitting. At 6-months abstinence was significantly
      increased in the intervention group versus the control group (10.7% vs. 4.9%; p<0.0001).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Exhaled Carbon Monoxide Levels
time frame: 1 month
description: self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels
arm group label: texting group
arm group type: Active Comparator
description: text messages focused on smoking cessation and pregnancy
arm group label: control group
arm group type: No Intervention
description: No text messages
intervention type: Behavioral
intervention name: text messages focused on smoking cessation and pregnancy
description: The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.
arm group label: texting group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Katherine J Mathews, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Katherine Mathews, MD
investigator title: Principal Investigator
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to challenges with recruitment and retention, the study was underpowered to detect statistical differences.
point of contact: 