<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/NCT01711060</url>
  </required_header>
  <id_info>
    <org_study_id>CICATAC</org_study_id>
    <nct_id>NCT01711060</nct_id>
  </id_info>
  <brief_title>A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <brief_summary>
    <textblock>
      Increasing cesarean rate in France is worrying. Different methods are described for ripening&#xD;
      labor : the use of prostaglandins is described but maybe dangerous for patients with scarred&#xD;
      uterus and is not recommended.&#xD;
&#xD;
      Intracervical balloon is an efficient alternative methods which as already been tested for&#xD;
      unfavorable cervix ripening on nulliparous women.&#xD;
&#xD;
      But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score&#xD;
      &lt;4).&#xD;
&#xD;
      The investigators propose a prospective randomised trial comparing cervix ripening with&#xD;
      intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin&#xD;
      (reference method).&#xD;
&#xD;
      The investigators expect to demonstrate what it's a safe method to increase vaginal delivery&#xD;
      for women with previous cesarean section who need an induction of labour.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Rate of childbirth by low way</measure>
    <description>The childbirth by low way being considered as a success of the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of incidence of materno-fœtales morbidity</measure>
    <description>number</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Scarred Uterus</condition>
  <arm_group>
    <arm_group_label>oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>balloon catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dufour 1859H18</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin</intervention_name>
    <arm_group_label>oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>balloon catheter</intervention_name>
    <arm_group_label>balloon catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy over 37 weeks&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Previous caesarean section with unique Transversal segmentary incision&#xD;
&#xD;
          -  Medical indication of induction of labor&#xD;
&#xD;
          -  Unfavorable cervix with Bishop score &lt; 4&#xD;
&#xD;
          -  No Premature Rupture Of Membranes&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Before 18 years old&#xD;
&#xD;
          -  Placenta Praevia&#xD;
&#xD;
          -  Premature Rupture Of Membranes&#xD;
&#xD;
          -  Uterine scar other than transversal segmentary incision&#xD;
&#xD;
          -  Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Fetal malpresentation&#xD;
&#xD;
          -  Cesarean indication&#xD;
&#xD;
          -  Latex allergy&#xD;
&#xD;
          -  No informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique</name>
      <address>
        <city>Angouleme</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique</name>
      <address>
        <city>Bressuire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique</name>
      <address>
        <city>Chatellerault</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique et médecine de la reproduction</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Gynécologie Obstétrique</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 10, 2016</last_update_submitted>
  <last_update_submitted_qc>October 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2016</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>Cicatrix</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_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/NCT01711060
org study id: CICATAC
nct id: NCT01711060
lead sponsor: 
Increasing cesarean rate in France is worrying. Different methods are described for ripening
      labor : the use of prostaglandins is described but maybe dangerous for patients with scarred
      uterus and is not recommended.

      Intracervical balloon is an efficient alternative methods which as already been tested for
      unfavorable cervix ripening on nulliparous women.

      But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score
      <4).

      The investigators propose a prospective randomised trial comparing cervix ripening with
      intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin
      (reference method).

      The investigators expect to demonstrate what it's a safe method to increase vaginal delivery
      for women with previous cesarean section who need an induction of labour.
measure: Rate of childbirth by low way
description: The childbirth by low way being considered as a success of the treatment
measure: Rate of incidence of materno-fœtales morbidity
description: number
arm group label: oxytocin
arm group type: Experimental
arm group label: balloon catheter
arm group type: Experimental
description: Dufour 1859H18
intervention type: Drug
intervention name: oxytocin
arm group label: oxytocin
intervention type: Procedure
intervention name: balloon catheter
arm group label: balloon catheter
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Cicatrix
mesh term: Oxytocin