<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/NCT02202083</url>
  </required_header>
  <id_info>
    <org_study_id>WCSH2014</org_study_id>
    <nct_id>NCT02202083</nct_id>
  </id_info>
  <brief_title>The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor</brief_title>
  <official_title>The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Second University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Second University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, the study about intervention on the induced abortion at trimester is so little.&#xD;
      So, the investigators want to compare the safety and effectiveness of different induced&#xD;
      labor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study , the investigators want to compare the safety and effectiveness of different&#xD;
      induced labor. The safety and effectiveness such as the success rate of induced labor and the&#xD;
      gestation outcome,etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>Phase 4</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>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The success rate of induced labor</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Labor; Forced or Induced, Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.&#xD;
This group is term gestaion,with bishop score less than 6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cook Balloon</intervention_name>
    <description>There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.&#xD;
This group is term gestaion,with bishop score less than 6.</description>
    <arm_group_label>oxytocin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestation age ≥37week&#xD;
&#xD;
          -  Single fetus&#xD;
&#xD;
          -  No serious complications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestation age &lt;37week&#xD;
&#xD;
          -  Multiple fetus&#xD;
&#xD;
          -  With serious complications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>li zhang, Dr</last_name>
    <role>Study Director</role>
    <affiliation>West China second Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>li zhang, Dr</last_name>
    <phone>+8613882198624</phone>
  </overall_contact>
  <location>
    <facility>
      <name>West China Second Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>qiang wei, Dr</last_name>
      <phone>+8613980729930</phone>
      <email>wei.qiang.99@163.com</email>
    </contact>
    <investigator>
      <last_name>qiang wei, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.motherchildren.com</url>
    <description>this link is the official website of our hospital.</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>June 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>June 4, 2015</last_update_submitted>
  <last_update_submitted_qc>June 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Second University Hospital</investigator_affiliation>
    <investigator_full_name>qiang wei</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Cook Balloon</keyword>
  <!-- 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/NCT02202083
org study id: WCSH2014
nct id: NCT02202083
lead sponsor: 
has dmc: Yes
Currently, the study about intervention on the induced abortion at trimester is so little.
      So, the investigators want to compare the safety and effectiveness of different induced
      labor.
In this study , the investigators want to compare the safety and effectiveness of different
      induced labor. The safety and effectiveness such as the success rate of induced labor and the
      gestation outcome,etc.
allocation: Randomized
intervention model: Single Group Assignment
masking: Double (Care Provider, Investigator)
measure: The success rate of induced labor
time frame: one year
arm group label: oxytocin
arm group type: Experimental
description: There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.
This group is term gestaion,with bishop score less than 6.
intervention type: Other
intervention name: Cook Balloon
description: There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.
This group is term gestaion,with bishop score less than 6.
arm group label: oxytocin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: li zhang, Dr
role: Study Director
affiliation: West China second Hospital
last name: li zhang, Dr
phone: +8613882198624
facility: 
status: Recruiting
contact: 
investigator: 
country: China
url: http://www.motherchildren.com
description: this link is the official website of our hospital.
responsible party type: Principal Investigator
investigator affiliation: West China Second University Hospital
investigator full name: qiang wei
investigator title: Dr