<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/NCT01684592</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DA032683-01A1</org_study_id>
    <nct_id>NCT01684592</nct_id>
  </id_info>
  <brief_title>Phone-Based Postpartum Continuing Care for Smoking Cessation</brief_title>
  <acronym>PPCC</acronym>
  <official_title>Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Battelle Memorial Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chestnut Health Systems</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Battelle Memorial Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Smoking is a leading cause of death and other negative health outcomes. While a high&#xD;
      percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months&#xD;
      postpartum. We propose developing and pilot testing a phone-based postpartum continuing care&#xD;
      (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation,&#xD;
      reduce relapse, increase early re-intervention, and reduce infant exposure to environmental&#xD;
      tobacco smoke in the postpartum period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The large majority of women who quit smoking during pregnancy relapse in the first six months&#xD;
      postpartum, highlighting a need for effective postpartum continuing care that supports women&#xD;
      through the challenging postpartum period when stress is high and motivation to stay quit may&#xD;
      decline. Existing relapse prevention interventions (typically delivered during pregnancy)&#xD;
      have been found to be of little benefit during the postpartum period, suggesting the need for&#xD;
      a more formal continuing care approach. Phone-based protocols for smoking cessation have been&#xD;
      widely disseminated and effective because they address the need for flexible access, but are&#xD;
      passive and not typically utilized by women in the postpartum period.&#xD;
&#xD;
      The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care&#xD;
      (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery&#xD;
      Management Checkups (RMC)-- shown to be effective with other populations. The experimental&#xD;
      PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking&#xD;
      through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women&#xD;
      are more likely to relapse, and provide education and monitoring of the infant's direct and&#xD;
      indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate&#xD;
      PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current&#xD;
      standard care.&#xD;
&#xD;
      Approximately one hundred thirty women in their first or second trimester of pregnancy who&#xD;
      were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days&#xD;
      will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in&#xD;
      Baltimore, Maryland. All women will receive the clinic's standard of care for smoking&#xD;
      cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned&#xD;
      to an experimental group getting PPCC for 6 months postpartum and half to a control group&#xD;
      receiving only a referral to a passive 24/7 state quit line postpartum. It is expected that&#xD;
      in the 6 months following childbirth women in the experimental PPCC (relative to those in the&#xD;
      control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before&#xD;
      postpartum relapse, d) have less time between relapse and talking to a health professional&#xD;
      about smoking, e) have less time between relapse and resumption of abstinence , f) smoke&#xD;
      fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant,&#xD;
      and h) reduce their infant's cotinine levels.&#xD;
&#xD;
      The aims of this pilot project are to develop PPCC from existing evidence-based approaches,&#xD;
      demonstrate the feasibility of implementing the PPCC intervention with at least 80%&#xD;
      compliance and at least 80% follow-up at each wave, and evaluate the effect size associated&#xD;
      with receiving standard care vs. standard care + PPCC in order to understand the promise of&#xD;
      and appropriate power required for a larger clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Tobacco Products Per Day</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Self-reported number of tobacco products smoked per day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Tobacco Products Per Day</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-reported number of tobacco products smoked per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past 90-day Tobacco Use</measure>
    <time_frame>3 months postpartum</time_frame>
    <description>Self-reported number of days smoked in past 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Past 90-day Tobacco Use</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Self-reported number of days smoked tobacco in past 90 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times Mother Smoked While Breastfeeding</measure>
    <time_frame>Baby's birth to 6 months postpartum</time_frame>
    <description>Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times Mother Smoked in the Room With Infant</measure>
    <time_frame>Baby's birth to 6 months postpartum</time_frame>
    <description>Based on the number of days of smoking in the same room with infant in the past 90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NicCheck Test Results for Cotinine Level From Infant Urine</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Infant urine was collected at 6 months postpartum using the &quot;cotton roll&quot; method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between &quot;low&quot; (score 1-6) versus &quot;high&quot; (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care plus PPCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phone-based postpartum continuing care</intervention_name>
    <description>PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
    <arm_group_label>Standard care plus PPCC</arm_group_label>
    <other_name>PPCC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_label>Standard care plus PPCC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first or second trimester of pregnancy&#xD;
&#xD;
          -  age 18 or older&#xD;
&#xD;
          -  self-reported tobacco use in the past 90 days or nicotine-dependence in the past year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intend to terminate their pregnancy&#xD;
&#xD;
          -  intend to move out of the city within the next 12 months&#xD;
&#xD;
          -  are unable to provide informed consent and participate in English&#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>Victoria H Coleman-Cowger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Battelle Memorial Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katrina Mark, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Maryland School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chestnut Global Partners</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Women's Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Coleman-Cowger VH. Smoking cessation intervention for pregnant women: a call for extension to the postpartum period. Matern Child Health J. 2012 Jul;16(5):937-40. doi: 10.1007/s10995-011-0837-2.</citation>
    <PMID>21710186</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>November 1, 2016</results_first_submitted>
  <results_first_submitted_qc>February 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2018</results_first_posted>
  <last_update_submitted>February 13, 2018</last_update_submitted>
  <last_update_submitted_qc>February 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Battelle Memorial Institute</investigator_affiliation>
    <investigator_full_name>Victoria H. Coleman-Cowger</investigator_full_name>
    <investigator_title>Principal Research Scientist</investigator_title>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>relapse prevention</keyword>
  <keyword>pregnancy</keyword>
  <keyword>postpartum</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Researchers may request de-identified aggregate data in 2017 via email from the PI of record by submitting a formal request with desired variables.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT01684592/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 28, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT01684592/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The sample was drawn from a population of low-income pregnant women attending their first prenatal visit at an obstetrics clinic in Baltimore, MD. In total, 790 women (i.e., smokers and non-smokers) were assessed for eligibility from March-December 2013, with 180 meeting eligibility criteria. Of those screened, 130 participants were enrolled.</recruitment_details>
      <pre_assignment_details>Randomization occurred at week 26 gestation, after intake data was collected.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from Maryland Women's Clinic (MWC) during pregnancy. The 5 A's brief intervention was modified by the American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
        </group>
        <group group_id="P2">
          <title>Standard Care Plus PPCC</title>
          <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
        </group>
        <group group_id="B2">
          <title>Standard Care Plus PPCC</title>
          <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</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="64"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="128"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.6" spread="4.7"/>
                    <measurement group_id="B2" value="26.3" spread="5.3"/>
                    <measurement group_id="B3" value="26.0" spread="5.0"/>
                  </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="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="128"/>
                  </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="53"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Tobacco Products Per Day</title>
        <description>Self-reported number of tobacco products smoked per day</description>
        <time_frame>6 months postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Tobacco Products Per Day</title>
          <description>Self-reported number of tobacco products smoked per day</description>
          <units>tobacco products</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" lower_limit="4" upper_limit="8"/>
                    <measurement group_id="O2" value="6.9" lower_limit="5" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Tobacco Products Per Day</title>
        <description>Self-reported number of tobacco products smoked per day</description>
        <time_frame>3 months postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Tobacco Products Per Day</title>
          <description>Self-reported number of tobacco products smoked per day</description>
          <units>tobacco products</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="5" upper_limit="9"/>
                    <measurement group_id="O2" value="7.9" lower_limit="6" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Past 90-day Tobacco Use</title>
        <description>Self-reported number of days smoked in past 90 days</description>
        <time_frame>3 months postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Past 90-day Tobacco Use</title>
          <description>Self-reported number of days smoked in past 90 days</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7" lower_limit="49" upper_limit="72"/>
                    <measurement group_id="O2" value="57.5" lower_limit="45" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Past 90-day Tobacco Use</title>
        <description>Self-reported number of days smoked tobacco in past 90 days.</description>
        <time_frame>6 months postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Past 90-day Tobacco Use</title>
          <description>Self-reported number of days smoked tobacco in past 90 days.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2" lower_limit="47" upper_limit="71"/>
                    <measurement group_id="O2" value="55.3" lower_limit="41" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Times Mother Smoked While Breastfeeding</title>
        <description>Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.</description>
        <time_frame>Baby's birth to 6 months postpartum</time_frame>
        <population>Only 7 women reported having breastfed at 6 month postpartum</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Times Mother Smoked While Breastfeeding</title>
          <description>Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.</description>
          <population>Only 7 women reported having breastfed at 6 month postpartum</population>
          <units>times smoked in past 90 days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.13" spread="4.6"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Times Mother Smoked in the Room With Infant</title>
        <description>Based on the number of days of smoking in the same room with infant in the past 90.</description>
        <time_frame>Baby's birth to 6 months postpartum</time_frame>
        <population>Only current smokers responded to this question</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Times Mother Smoked in the Room With Infant</title>
          <description>Based on the number of days of smoking in the same room with infant in the past 90.</description>
          <population>Only current smokers responded to this question</population>
          <units>number of days smoked</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".70" spread="3.5"/>
                    <measurement group_id="O2" value=".06" spread=".3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NicCheck Test Results for Cotinine Level From Infant Urine</title>
        <description>Infant urine was collected at 6 months postpartum using the &quot;cotton roll&quot; method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between &quot;low&quot; (score 1-6) versus &quot;high&quot; (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.</description>
        <time_frame>6 months postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Plus PPCC</title>
            <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>NicCheck Test Results for Cotinine Level From Infant Urine</title>
          <description>Infant urine was collected at 6 months postpartum using the &quot;cotton roll&quot; method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between &quot;low&quot; (score 1-6) versus &quot;high&quot; (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)&#xD;
Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.</description>
        </group>
        <group group_id="E2">
          <title>Standard Care Plus PPCC</title>
          <description>Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum&#xD;
Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.</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="5" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Miscarriage</sub_title>
                <description>Five participants miscarried prior to randomization at week 26 but following study enrollment.</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="64"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="64"/>
              </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="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </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>Trend of Experimental group being heavier smokers than Control group; Difficulty contacting participants for PPCC calls (limited delivery of intervention).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Victoria Coleman-Cowger</name_or_title>
      <organization>Battelle</organization>
      <phone>4103722748</phone>
      <email>colemancowger@battelle.org</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/NCT01684592
org study id: 1R34DA032683-01A1
nct id: NCT01684592
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Smoking is a leading cause of death and other negative health outcomes. While a high
      percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months
      postpartum. We propose developing and pilot testing a phone-based postpartum continuing care
      (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation,
      reduce relapse, increase early re-intervention, and reduce infant exposure to environmental
      tobacco smoke in the postpartum period.
The large majority of women who quit smoking during pregnancy relapse in the first six months
      postpartum, highlighting a need for effective postpartum continuing care that supports women
      through the challenging postpartum period when stress is high and motivation to stay quit may
      decline. Existing relapse prevention interventions (typically delivered during pregnancy)
      have been found to be of little benefit during the postpartum period, suggesting the need for
      a more formal continuing care approach. Phone-based protocols for smoking cessation have been
      widely disseminated and effective because they address the need for flexible access, but are
      passive and not typically utilized by women in the postpartum period.

      The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care
      (PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery
      Management Checkups (RMC)-- shown to be effective with other populations. The experimental
      PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking
      through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women
      are more likely to relapse, and provide education and monitoring of the infant's direct and
      indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate
      PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current
      standard care.

      Approximately one hundred thirty women in their first or second trimester of pregnancy who
      were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days
      will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in
      Baltimore, Maryland. All women will receive the clinic's standard of care for smoking
      cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned
      to an experimental group getting PPCC for 6 months postpartum and half to a control group
      receiving only a referral to a passive 24/7 state quit line postpartum. It is expected that
      in the 6 months following childbirth women in the experimental PPCC (relative to those in the
      control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before
      postpartum relapse, d) have less time between relapse and talking to a health professional
      about smoking, e) have less time between relapse and resumption of abstinence , f) smoke
      fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant,
      and h) reduce their infant's cotinine levels.

      The aims of this pilot project are to develop PPCC from existing evidence-based approaches,
      demonstrate the feasibility of implementing the PPCC intervention with at least 80%
      compliance and at least 80% follow-up at each wave, and evaluate the effect size associated
      with receiving standard care vs. standard care + PPCC in order to understand the promise of
      and appropriate power required for a larger clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of Tobacco Products Per Day
time frame: 6 months postpartum
description: Self-reported number of tobacco products smoked per day
measure: Number of Tobacco Products Per Day
time frame: 3 months postpartum
description: Self-reported number of tobacco products smoked per day
measure: Past 90-day Tobacco Use
time frame: 3 months postpartum
description: Self-reported number of days smoked in past 90 days
measure: Past 90-day Tobacco Use
time frame: 6 months postpartum
description: Self-reported number of days smoked tobacco in past 90 days.
measure: Times Mother Smoked While Breastfeeding
time frame: Baby's birth to 6 months postpartum
description: Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.
measure: Times Mother Smoked in the Room With Infant
time frame: Baby's birth to 6 months postpartum
description: Based on the number of days of smoking in the same room with infant in the past 90.
measure: NicCheck Test Results for Cotinine Level From Infant Urine
time frame: 6 months postpartum
description: Infant urine was collected at 6 months postpartum using the "cotton roll" method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between "low" (score 1-6) versus "high" (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.
arm group label: Standard care
arm group type: Active Comparator
description: Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)
arm group label: Standard care plus PPCC
arm group type: Experimental
description: Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum
intervention type: Behavioral
intervention name: Phone-based postpartum continuing care
description: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.
arm group label: Standard care plus PPCC
other name: PPCC
intervention type: Behavioral
intervention name: Standard care
description: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.
arm group label: Standard care
arm group label: Standard care plus PPCC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria H Coleman-Cowger, PhD
role: Principal Investigator
affiliation: Battelle Memorial Institute
last name: Katrina Mark, MD
role: Study Director
affiliation: University of Maryland School of Medicine
facility: 
facility: 
country: United States
citation: Coleman-Cowger VH. Smoking cessation intervention for pregnant women: a call for extension to the postpartum period. Matern Child Health J. 2012 Jul;16(5):937-40. doi: 10.1007/s10995-011-0837-2.
PMID: 21710186
responsible party type: Principal Investigator
investigator affiliation: Battelle Memorial Institute
investigator full name: Victoria H. Coleman-Cowger
investigator title: Principal Research Scientist
sharing ipd: No
ipd description: Researchers may request de-identified aggregate data in 2017 via email from the PI of record by submitting a formal request with desired variables.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Trend of Experimental group being heavier smokers than Control group; Difficulty contacting participants for PPCC calls (limited delivery of intervention).
point of contact: 