<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/NCT01734434</url>
  </required_header>
  <id_info>
    <org_study_id>V98_15OB</org_study_id>
    <nct_id>NCT01734434</nct_id>
  </id_info>
  <brief_title>Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems</brief_title>
  <official_title>A Multicenter, Observational Study to Identify Factors That Influence Access of Pregnant Women and Their Infants to Their Local Healthcare Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study collected information regarding the factors that might influence access of&#xD;
      pregnant women to the local healthcare system. The main visits of the study screened &amp;&#xD;
      enrollment, delivery and 90 day infant follow-up. Data were collected mainly from&#xD;
      questionnaires administered to pregnant women at these visits. The questionnaires contained&#xD;
      the following standard questions which were asked at each visit, in addition to some&#xD;
      visit-specific questions related to delivery and health status of infants up to 90 days of&#xD;
      age. The standard questions related to the following aspects:&#xD;
&#xD;
        -  Logistics of transportation to the study site (type, time it takes, cost incurred)&#xD;
&#xD;
        -  Accessibility to a telephone/cell phone&#xD;
&#xD;
        -  Provisions of alternative child care during site visits if there are other children&#xD;
           under the subject's care&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Delivering at a Study Site.</measure>
    <time_frame>Baseline until average of 24 weeks</time_frame>
    <description>The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Delivering at a Non-study Site.</measure>
    <time_frame>Baseline until average of 24 weeks</time_frame>
    <description>The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.</measure>
    <time_frame>Delivery to Day 90 post-delivery (Infant follow-up)</time_frame>
    <description>The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)</measure>
    <time_frame>Delivery to Day 90 post-delivery (Infant follow-up)</time_frame>
    <description>The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3243</enrollment>
  <condition>Pregnancy, Newborn Health</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>24 weeks or more of gestation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women of gestational age 24 weeks or more&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women with gestational age of greater than or equal to 24 weeks at the time&#xD;
             of enrollment&#xD;
&#xD;
          2. Subject / subject's parents or a legal representative who has given written consent&#xD;
             after the nature of the study has been explained according to local regulatory&#xD;
             requirements&#xD;
&#xD;
          3. Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Vaccines and Diagnostics</last_name>
    <role>Study Chair</role>
    <affiliation>Novartis Vaccines</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Sanitario de Santo Domingo</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternidad Nuestra Senora de La Altagracia</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CISM Manhica Health Research Centre</name>
      <address>
        <city>Manhiça</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policentro Juan Diaz</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policentro Parque Lefevre</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlínica JJ Vallarino</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Infectious Diseases Clinical Research Unit</name>
      <address>
        <city>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Setshaba Research Centre</name>
      <address>
        <city>Gauteng</city>
        <zip>0152</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Research Centre</name>
      <address>
        <city>Gauteng</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Respiratory and Meningeal Pathogens Research Unit</name>
      <address>
        <city>Soweto, Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
    <country>Mozambique</country>
    <country>Panama</country>
    <country>South Africa</country>
  </location_countries>
  <reference>
    <citation>WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.</citation>
  </reference>
  <reference>
    <citation>Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.</citation>
  </reference>
  <reference>
    <citation>Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available.</citation>
    <PMID>19106756</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>January 8, 2016</results_first_submitted>
  <results_first_submitted_qc>May 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 11, 2018</results_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health care access, Pregnant women</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at Dominican Republic, Panama, Mozambique, and South Africa.</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Maternal Subjects (Dominican Republic)</title>
          <description>Pregnant women who were enrolled in Dominican Republic.</description>
        </group>
        <group group_id="P2">
          <title>Maternal Subjects (Panama)</title>
          <description>Pregnant women who were enrolled in Panama.</description>
        </group>
        <group group_id="P3">
          <title>Maternal Subjects (South Africa)</title>
          <description>Pregnant women who were enrolled in South Africa.</description>
        </group>
        <group group_id="P4">
          <title>Maternal Subjects (Mozambique)</title>
          <description>Pregnant women who were enrolled in Mozambique.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="500"/>
                <participants group_id="P2" count="500"/>
                <participants group_id="P3" count="1992"/>
                <participants group_id="P4" count="251"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="490"/>
                <participants group_id="P2" count="488"/>
                <participants group_id="P3" count="1863"/>
                <participants group_id="P4" count="228"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="129"/>
                <participants group_id="P4" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death Infant</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="67"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Live Birth</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Signed Adult Version of Consent Form</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Not Reachable</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Treatment Defaulter</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Wrong Version of Consent Form Signed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>17 Yr Old Subject Signed Consent form</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographic data was analysed on Full analysis set (FAS) population-All subjects in the all enrolled set who provided data after enrollment related to delivery, logistics or medical outcomes.</population>
      <group_list>
        <group group_id="B1">
          <title>Maternal Subjects (Dominican Republic)</title>
          <description>Pregnant women who were enrolled in Dominican Republic.</description>
        </group>
        <group group_id="B2">
          <title>Maternal Subjects (Panama)</title>
          <description>Pregnant women who were enrolled in Panama.</description>
        </group>
        <group group_id="B3">
          <title>Maternal Subjects (South Africa)</title>
          <description>Pregnant women who were enrolled in South Africa.</description>
        </group>
        <group group_id="B4">
          <title>Maternal Subjects (Mozambique)</title>
          <description>Pregnant women who were enrolled in Mozambique.</description>
        </group>
        <group group_id="B5">
          <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="500"/>
            <count group_id="B2" value="500"/>
            <count group_id="B3" value="1989"/>
            <count group_id="B4" value="251"/>
            <count group_id="B5" value="3240"/>
          </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="24.49" spread="5.28"/>
                    <measurement group_id="B2" value="25.08" spread="5.65"/>
                    <measurement group_id="B3" value="27.05" spread="6.05"/>
                    <measurement group_id="B4" value="25.01" spread="6.26"/>
                    <measurement group_id="B5" value="26.19" spread="5.99"/>
                  </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="500"/>
                    <measurement group_id="B2" value="500"/>
                    <measurement group_id="B3" value="1989"/>
                    <measurement group_id="B4" value="251"/>
                    <measurement group_id="B5" value="3240"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Delivering at a Study Site.</title>
        <description>The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated</description>
        <time_frame>Baseline until average of 24 weeks</time_frame>
        <population>Analysis was done on Full analysis set (FAS)-All subjects in the All Enrolled Set who provided data after enrollment related to delivery, logistics or medical outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Subjects (Dominican Republic)</title>
            <description>Pregnant women who were enrolled in Dominican Republic.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Subjects (Panama)</title>
            <description>Pregnant women who were enrolled in Panama.</description>
          </group>
          <group group_id="O3">
            <title>Maternal Subjects (South Africa)</title>
            <description>Pregnant women who were enrolled in South Africa.</description>
          </group>
          <group group_id="O4">
            <title>Maternal Subjects (Mozambique)</title>
            <description>Pregnant women who were enrolled in Mozambique.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Delivering at a Study Site.</title>
          <description>The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated</description>
          <population>Analysis was done on Full analysis set (FAS)-All subjects in the All Enrolled Set who provided data after enrollment related to delivery, logistics or medical outcomes.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="500"/>
                <count group_id="O2" value="500"/>
                <count group_id="O3" value="1989"/>
                <count group_id="O4" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with known delivery information</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.20" lower_limit="97.96" upper_limit="99.78"/>
                    <measurement group_id="O2" value="100" lower_limit="99.26" upper_limit="100"/>
                    <measurement group_id="O3" value="99.65" lower_limit="99.28" upper_limit="99.86"/>
                    <measurement group_id="O4" value="100" lower_limit="98.54" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study site delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.55" lower_limit="64.26" upper_limit="72.61"/>
                    <measurement group_id="O2" value="74.40" lower_limit="70.34" upper_limit="78.17"/>
                    <measurement group_id="O3" value="56.66" lower_limit="54.44" upper_limit="58.86"/>
                    <measurement group_id="O4" value="86.85" lower_limit="82.03" upper_limit="90.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Delivering at a Non-study Site.</title>
        <description>The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.</description>
        <time_frame>Baseline until average of 24 weeks</time_frame>
        <population>Analysis was done on FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Subjects (Dominican Republic)</title>
            <description>Pregnant women who were enrolled in Dominican Republic.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Subjects (Panama)</title>
            <description>Pregnant women who were enrolled in Panama.</description>
          </group>
          <group group_id="O3">
            <title>Maternal Subjects (South Africa)</title>
            <description>Pregnant women who were enrolled in South Africa.</description>
          </group>
          <group group_id="O4">
            <title>Maternal Subjects (Mozambique)</title>
            <description>Pregnant women who were enrolled in Mozambique.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Delivering at a Non-study Site.</title>
          <description>The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.</description>
          <population>Analysis was done on FAS.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="500"/>
                <count group_id="O2" value="500"/>
                <count group_id="O3" value="1989"/>
                <count group_id="O4" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with known delivery information</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.20" lower_limit="97.96" upper_limit="99.78"/>
                    <measurement group_id="O2" value="100" lower_limit="99.26" upper_limit="100"/>
                    <measurement group_id="O3" value="99.65" lower_limit="99.28" upper_limit="99.86"/>
                    <measurement group_id="O4" value="100" lower_limit="98.54" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-study healthcare facility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.85" lower_limit="26.81" upper_limit="35.12"/>
                    <measurement group_id="O2" value="24.60" lower_limit="20.88" upper_limit="28.62"/>
                    <measurement group_id="O3" value="41.32" lower_limit="39.14" upper_limit="43.53"/>
                    <measurement group_id="O4" value="7.97" lower_limit="4.93" upper_limit="12.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0.40" lower_limit="0.05" upper_limit="1.44"/>
                    <measurement group_id="O3" value="0.76" lower_limit="0.42" upper_limit="1.25"/>
                    <measurement group_id="O4" value="2.79" lower_limit="1.13" upper_limit="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0.50" lower_limit="0.24" upper_limit="0.93"/>
                    <measurement group_id="O4" value="0.40" lower_limit="0.01" upper_limit="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" lower_limit="0.12" upper_limit="1.76"/>
                    <measurement group_id="O2" value="0.60" lower_limit="0.12" upper_limit="1.74"/>
                    <measurement group_id="O3" value="0.76" lower_limit="0.42" upper_limit="1.25"/>
                    <measurement group_id="O4" value="1.99" lower_limit="0.65" upper_limit="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.</title>
        <description>The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated.</description>
        <time_frame>Delivery to Day 90 post-delivery (Infant follow-up)</time_frame>
        <population>Analysis was done on the FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Subjects(Dominican Republic)</title>
            <description>pregnant women who were enrolled in Dominican Republic.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Subjects(Panama)</title>
            <description>pregnant women who were enrolled in Panama.</description>
          </group>
          <group group_id="O3">
            <title>Maternal Subjects (South Africa)</title>
            <description>pregnant women who were enrolled in South Africa.</description>
          </group>
          <group group_id="O4">
            <title>Maternal Subjects(Mozambique)</title>
            <description>pregnant women who were enrolled in Mozambique.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.</title>
          <description>The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated.</description>
          <population>Analysis was done on the FAS</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="493"/>
                <count group_id="O2" value="498"/>
                <count group_id="O3" value="1966"/>
                <count group_id="O4" value="242"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Live births at discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493"/>
                    <measurement group_id="O2" value="498"/>
                    <measurement group_id="O3" value="1966"/>
                    <measurement group_id="O4" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infants reported sick</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="74"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infants brought to health care facility-study site</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="147"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)</title>
        <description>The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries.</description>
        <time_frame>Delivery to Day 90 post-delivery (Infant follow-up)</time_frame>
        <population>Analysis was performed on the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Infants (Dominican Republic)</title>
            <description>Infants born to pregnant women who were enrolled in Dominican Republic, brought to study site for 90-day follow up.</description>
          </group>
          <group group_id="O2">
            <title>Infants (Panama)</title>
            <description>Infants born to pregnant women who were enrolled in Panama, brought to study site for 90-day follow up.</description>
          </group>
          <group group_id="O3">
            <title>Infants (South Africa)</title>
            <description>Infants born to pregnant women who were enrolled in South Africa, brought to study site for 90-day follow up.</description>
          </group>
          <group group_id="O4">
            <title>Infants (Mozambique)</title>
            <description>Infants born to pregnant women who were enrolled in Mozambique, brought to study site for 90-day follow up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)</title>
          <description>The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries.</description>
          <population>Analysis was performed on the FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="493"/>
                <count group_id="O2" value="498"/>
                <count group_id="O3" value="1966"/>
                <count group_id="O4" value="242"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="479"/>
                    <measurement group_id="O2" value="333"/>
                    <measurement group_id="O3" value="1163"/>
                    <measurement group_id="O4" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse event data were not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Maternal Subjects (Dominican Republic)</title>
          <description>Pregnant women who were enrolled in Dominican Republic.</description>
        </group>
        <group group_id="E2">
          <title>Maternal Subjects (Panama)</title>
          <description>Pregnant women who were enrolled in Panama.</description>
        </group>
        <group group_id="E3">
          <title>Maternal Subjects (South Africa)</title>
          <description>Pregnant women who were enrolled in South Africa.</description>
        </group>
        <group group_id="E4">
          <title>Maternal Subjects (Mozambique)</title>
          <description>Pregnant women who were enrolled in Mozambique.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines and Diagnostics</organization>
      <email>RegistryContactVaccinesUS@novartis.com</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/NCT01734434
org study id: V98_15OB
nct id: NCT01734434
lead sponsor: 
collaborator: 
has dmc: No
This study collected information regarding the factors that might influence access of
      pregnant women to the local healthcare system. The main visits of the study screened &
      enrollment, delivery and 90 day infant follow-up. Data were collected mainly from
      questionnaires administered to pregnant women at these visits. The questionnaires contained
      the following standard questions which were asked at each visit, in addition to some
      visit-specific questions related to delivery and health status of infants up to 90 days of
      age. The standard questions related to the following aspects:

        -  Logistics of transportation to the study site (type, time it takes, cost incurred)

        -  Accessibility to a telephone/cell phone

        -  Provisions of alternative child care during site visits if there are other children
           under the subject's care
observational model: Ecologic or Community
time perspective: Prospective
measure: Percentage of Subjects Delivering at a Study Site.
time frame: Baseline until average of 24 weeks
description: The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated
measure: Percentage of Subjects Delivering at a Non-study Site.
time frame: Baseline until average of 24 weeks
description: The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.
measure: Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.
time frame: Delivery to Day 90 post-delivery (Infant follow-up)
description: The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated.
measure: Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)
time frame: Delivery to Day 90 post-delivery (Infant follow-up)
description: The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries.
arm group label: Pregnant women
description: 24 weeks or more of gestation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Novartis Vaccines and Diagnostics
role: Study Chair
affiliation: Novartis Vaccines
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Dominican Republic
country: Mozambique
country: Panama
country: South Africa
citation: WHO. Antenatal care in developing countries. Promises, achievements and missed opportunities. An analysis of trends, levels and differentials, 1990-2001. Geneva: 2003.
citation: Assembly UNG. A world fit for children. Outcome document of the Special Session on Children. New York: 2002.
citation: Qazi SA, Stoll BJ. Neonatal sepsis: a major global public health challenge. Pediatr Infect Dis J. 2009 Jan;28(1 Suppl):S1-2. doi: 10.1097/INF.0b013e31819587a9. No abstract available.
PMID: 19106756
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 