<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/NCT03007797</url>
  </required_header>
  <id_info>
    <org_study_id>homwo 01</org_study_id>
    <nct_id>NCT03007797</nct_id>
  </id_info>
  <brief_title>Realization of the Recommendation for Influenza Vaccination in Pregnant Women</brief_title>
  <official_title>Women - Influencing Factors and Coverage Rate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Saarland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Klinikum Worms</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Saarland</source>
  <brief_summary>
    <textblock>
      Introduction:&#xD;
&#xD;
      In 2010, the vaccination recommendations for pregnant women against seasonal influenza were&#xD;
      published by the German Standing Committee on Vaccination (STIKO). This work deals with the&#xD;
      immunization coverage and the influencing factors.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      A cross-sectional study was realized at two Level 1 perinatal centers in two German federal&#xD;
      states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed&#xD;
      by using a standardized and pre-tested questionnaire covering their knowledge about the&#xD;
      influenza vaccination and other factors influencing the vaccination decision. Furthermore,&#xD;
      data from the vaccination card and the pregnancy record booklet have been evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Influenza Vaccination rate in Pregnant Women</measure>
    <time_frame>02/12- 02/14</time_frame>
    <description>The first aim of the study is check how many pregnant women are following the new german recommendation of influenza vaccination in pregnancy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>influencing factors on the Influenza vaccination rate</measure>
    <time_frame>02/12- 02/14</time_frame>
    <description>Second aim is to investigate the factors which are influencing the decission for or against the influenza vaccination in pregnancy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">236</enrollment>
  <condition>Coverage Rate of Vaccination for Influenza</condition>
  <arm_group>
    <arm_group_label>vaccination rate- pregnant- influenca</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>vaccination rate for influenza</intervention_name>
    <arm_group_label>vaccination rate- pregnant- influenca</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        236 pregnant women in 2 centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women older than 18&#xD;
&#xD;
          -  vaccination records&#xD;
&#xD;
          -  signatetd letter of agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03007797
org study id: homwo 01
nct id: NCT03007797
lead sponsor: 
collaborator: 
Introduction:

      In 2010, the vaccination recommendations for pregnant women against seasonal influenza were
      published by the German Standing Committee on Vaccination (STIKO). This work deals with the
      immunization coverage and the influencing factors.

      Method:

      A cross-sectional study was realized at two Level 1 perinatal centers in two German federal
      states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed
      by using a standardized and pre-tested questionnaire covering their knowledge about the
      influenza vaccination and other factors influencing the vaccination decision. Furthermore,
      data from the vaccination card and the pregnancy record booklet have been evaluated.
observational model: Cohort
time perspective: Prospective
measure: Influenza Vaccination rate in Pregnant Women
time frame: 02/12- 02/14
description: The first aim of the study is check how many pregnant women are following the new german recommendation of influenza vaccination in pregnancy.
measure: influencing factors on the Influenza vaccination rate
time frame: 02/12- 02/14
description: Second aim is to investigate the factors which are influencing the decission for or against the influenza vaccination in pregnancy.
arm group label: vaccination rate- pregnant- influenca
intervention type: Behavioral
intervention name: vaccination rate for influenza
arm group label: vaccination rate- pregnant- influenca
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Influenza, Human