<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/NCT01709591</url>
  </required_header>
  <id_info>
    <org_study_id>10-081</org_study_id>
    <nct_id>NCT01709591</nct_id>
  </id_info>
  <brief_title>Effect of Prenatal Education on Perceptions of Epidural Acceptance</brief_title>
  <official_title>Effect of Targeted Prenatal Education on Perceptions of Epidural on Acceptance of Epidural Analgesia: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santa Clara Valley Health &amp; Hospital System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Santa Clara Valley Health &amp; Hospital System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if targeted prenatal educational program on womens'&#xD;
      perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative&#xD;
      to the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia.&#xD;
      The purpose of our study is to determine if culturally-sensitive educational program&#xD;
      targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural&#xD;
      use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey</measure>
    <time_frame>One year time period</time_frame>
    <description>All subjects will be asked to fill out the Perceptions on Epidural Questionnaire (PEQ) to elucidate their desire to receive intrapartum pain control &amp; their attitude towards epidural to patients. Each survey will take approximately five to ten minutes to complete. The survey will be distributed in English and Spanish.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>No Prenatal education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These subjects will be randomized to receive routine prenatal epidural class (control group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Receives Prenatal Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to this group will receive educational video addressing the cultural and perceptions regarding the myths on epidural in either English or Spanish (Keeping an Open Mind: choices in Labor Anaglesia: an educational produce of the Society for Obstetric Anesthesia and perinatology)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prenatal education</intervention_name>
    <arm_group_label>Receives Prenatal Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with viable intrauterine gestation seeking prenatal care&#xD;
&#xD;
          2. Candidates for Intrapartum epidural analgesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intrapartum epidural analgesia is contraindicated&#xD;
&#xD;
          2. Trial of labor is contraindicated.&#xD;
&#xD;
          3. Patients planning an elective cesarean&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anita Sit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Santa Clara Valley Health and Hospital System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Santa Clara Valley Health and Hospital System</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intrapartum pain management, epidural</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</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/NCT01709591
org study id: 10-081
nct id: NCT01709591
lead sponsor: 
has dmc: No
The purpose of the study is to determine if targeted prenatal educational program on womens'
      perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative
      to the control group.
Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia.
      The purpose of our study is to determine if culturally-sensitive educational program
      targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural
      use.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey
time frame: One year time period
description: All subjects will be asked to fill out the Perceptions on Epidural Questionnaire (PEQ) to elucidate their desire to receive intrapartum pain control & their attitude towards epidural to patients. Each survey will take approximately five to ten minutes to complete. The survey will be distributed in English and Spanish.
arm group label: No Prenatal education
arm group type: No Intervention
description: These subjects will be randomized to receive routine prenatal epidural class (control group).
arm group label: Receives Prenatal Education
arm group type: Active Comparator
description: Subjects randomized to this group will receive educational video addressing the cultural and perceptions regarding the myths on epidural in either English or Spanish (Keeping an Open Mind: choices in Labor Anaglesia: an educational produce of the Society for Obstetric Anesthesia and perinatology)
intervention type: Behavioral
intervention name: Prenatal education
arm group label: Receives Prenatal Education
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anita Sit, MD
role: Principal Investigator
affiliation: Santa Clara Valley Health and Hospital System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Labor Pain