<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/NCT02196103</url>
  </required_header>
  <id_info>
    <org_study_id>0019-14-HYMC</org_study_id>
    <nct_id>NCT02196103</nct_id>
  </id_info>
  <brief_title>Management of Labor in Patients With Previous Cesarian Section</brief_title>
  <official_title>Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity&#xD;
      of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has&#xD;
      led us to undertake the present clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</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>vaginal delivery rate</measure>
    <time_frame>48 hours</time_frame>
    <description>20% higher vaginal delivery rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safety</measure>
    <time_frame>48 hours</time_frame>
    <description>safety of the double balloon device in women with one previous cesarian section and PROM at &gt;/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>satisfaction</measure>
    <time_frame>48 hours</time_frame>
    <description>maternal experience and satisfaction with the method of delivery that was applied</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pregnancy</condition>
  <condition>Previous Cesarian Section</condition>
  <condition>Premature Rupture of Membranes (PROM)</condition>
  <arm_group>
    <arm_group_label>Expectant management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double balloon cervical catheter</intervention_name>
    <arm_group_label>Expectant management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed to be pregnant with PROM at &gt;34 weeks. Rupture of membranes will be&#xD;
             determine clinically and confirmed by positive Nitrazine test.&#xD;
&#xD;
          -  Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.&#xD;
&#xD;
          -  Found to have an unripe cervix in a speculum examination.&#xD;
&#xD;
          -  Singleton pregnancy in a vertex presentation well applied to the cervix and absence of&#xD;
             significant and regular uterine contractions (3-5/10 Min)&#xD;
&#xD;
          -  Previous on cesarian section.&#xD;
&#xD;
          -  Willingness to comply with the protocol for the duration of the study.&#xD;
&#xD;
          -  Have signed an informed consent.&#xD;
&#xD;
        Exclusion Criteria: Patients having any of the following conditions:&#xD;
&#xD;
          -  Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex&#xD;
             presentation).&#xD;
&#xD;
          -  Regular uterine contractions (3-5/10 min).&#xD;
&#xD;
          -  Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.&#xD;
&#xD;
          -  Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and&#xD;
             maternal or fetal tachycardia or purulent discharge or WBC&gt;/=20,000)&#xD;
&#xD;
          -  Suspected placental abruption or presence of a significant hemorrhage.&#xD;
&#xD;
          -  Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or&#xD;
             bio-physical profile) necessitating immediate intervention.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asnat Walfisch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asnat Walfisch, MD</last_name>
    <phone>050-4492200</phone>
  </overall_contact>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TOLAC</keyword>
  <keyword>PROM</keyword>
  <keyword>Previous Cesarian section</keyword>
  <keyword>Mechanical cervical ripening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Rupture</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/NCT02196103
org study id: 0019-14-HYMC
nct id: NCT02196103
lead sponsor: 
has dmc: Yes
Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity
      of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has
      led us to undertake the present clinical trial.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: vaginal delivery rate
time frame: 48 hours
description: 20% higher vaginal delivery rate
measure: safety
time frame: 48 hours
description: safety of the double balloon device in women with one previous cesarian section and PROM at >/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony.
measure: satisfaction
time frame: 48 hours
description: maternal experience and satisfaction with the method of delivery that was applied
arm group label: Expectant management
arm group type: Experimental
intervention type: Device
intervention name: Double balloon cervical catheter
arm group label: Expectant management
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Asnat Walfisch, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Asnat Walfisch, MD
phone: 050-4492200
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture