<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/NCT03033264</url>
  </required_header>
  <id_info>
    <org_study_id>0192-19-RMB</org_study_id>
    <nct_id>NCT03033264</nct_id>
  </id_info>
  <brief_title>Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.</brief_title>
  <official_title>A Comparison Between Labor Induction With Dinoprostone and a Cervical Ripening Balloon in Women With a BMI&gt;30 as Oppose With a BMI&lt;30.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women with a BMI&gt;30 and women with a BMI&lt;30 will be divided in a randomized controlled manor&#xD;
      to 4 groups depending on the mode of labor induction and BMI value:&#xD;
&#xD;
        1. Dinoprostone in women with a BMI&gt;30.&#xD;
&#xD;
        2. Dinoprostone in women with a BMI&lt;30.&#xD;
&#xD;
        3. Cervical ripening balloon in women with a BMI&gt;30.&#xD;
&#xD;
        4. Cervical ripening balloon in women with a BMI&lt;30. The subjects will be followed until&#xD;
           labor, and information regarding the success of induction, mode of delivery and time of&#xD;
           delivery will be collected from patients' electronic files.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized controlled test in which women with a BMI&gt;30 and women with a&#xD;
      BMI&lt;30 will sign an informed consent and then divided to 4 groups depending on the mode of&#xD;
      labor induction and BMI value:&#xD;
&#xD;
        1. Dinoprostone in women with a BMI&gt;30.&#xD;
&#xD;
        2. Dinoprostone in women with a BMI&lt;30.&#xD;
&#xD;
        3. Cervical ripening balloon in women with a BMI&gt;30.&#xD;
&#xD;
        4. Cervical ripening balloon in women with a BMI&lt;30. All subjects participating in the&#xD;
           study will be induced for obstetrical indications alone.&#xD;
&#xD;
      The subjects will be followed until labor, and information regarding the success of&#xD;
      induction, mode of delivery and time of delivery will be collected from patients' electronic&#xD;
      files.&#xD;
&#xD;
      The participants will finish participation in the study after delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>Up to 5 days.</time_frame>
    <description>Vaginal delivery in oppose to cesarean section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to delivery</measure>
    <time_frame>Up to 5 days.</time_frame>
    <description>Time from insertion of induction device\drug until delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Induction success.</measure>
    <time_frame>Up to 5 days.</time_frame>
    <description>Cervical dilatation and effacement after cessation of induction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal complications and outcome.</measure>
    <time_frame>Up to 5 days.</time_frame>
    <description>Any neonatal complications as mentioned In the neonate's electronic file.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Induction of Labor</condition>
  <arm_group>
    <arm_group_label>BMI&gt;30+Dinoprostone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with a BMI&gt;30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI&lt;30+Dinoprostone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with a BMI&lt;30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI&gt;30+Cervical ripening balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with a BMI&gt;30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI&lt;30+Cervical ripening balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with a BMI&lt;30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dinoprostone</intervention_name>
    <description>10 mg of a Dinoprostone vaginal insert.</description>
    <arm_group_label>BMI&lt;30+Dinoprostone</arm_group_label>
    <arm_group_label>BMI&gt;30+Dinoprostone</arm_group_label>
    <other_name>Prostaglandin E2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double lumen cervical ripening balloon.</intervention_name>
    <description>Double lumen cervical ripening balloon.</description>
    <arm_group_label>BMI&lt;30+Cervical ripening balloon</arm_group_label>
    <arm_group_label>BMI&gt;30+Cervical ripening balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any pregnant woman at term with an obstetric indication for labor induction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cesarean section.&#xD;
&#xD;
          -  Positive Oxytocin challenge test.&#xD;
&#xD;
          -  Positive contraction stress test.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ROY LAUTERBACH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam health care campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>ROY LAUTERBACH MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dinoprostone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03033264
org study id: 0192-19-RMB
nct id: NCT03033264
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Women with a BMI>30 and women with a BMI<30 will be divided in a randomized controlled manor
      to 4 groups depending on the mode of labor induction and BMI value:

        1. Dinoprostone in women with a BMI>30.

        2. Dinoprostone in women with a BMI<30.

        3. Cervical ripening balloon in women with a BMI>30.

        4. Cervical ripening balloon in women with a BMI<30. The subjects will be followed until
           labor, and information regarding the success of induction, mode of delivery and time of
           delivery will be collected from patients' electronic files.
The study is a randomized controlled test in which women with a BMI>30 and women with a
      BMI<30 will sign an informed consent and then divided to 4 groups depending on the mode of
      labor induction and BMI value:

        1. Dinoprostone in women with a BMI>30.

        2. Dinoprostone in women with a BMI<30.

        3. Cervical ripening balloon in women with a BMI>30.

        4. Cervical ripening balloon in women with a BMI<30. All subjects participating in the
           study will be induced for obstetrical indications alone.

      The subjects will be followed until labor, and information regarding the success of
      induction, mode of delivery and time of delivery will be collected from patients' electronic
      files.

      The participants will finish participation in the study after delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mode of delivery
time frame: Up to 5 days.
description: Vaginal delivery in oppose to cesarean section.
measure: Time to delivery
time frame: Up to 5 days.
description: Time from insertion of induction device\drug until delivery.
measure: Induction success.
time frame: Up to 5 days.
description: Cervical dilatation and effacement after cessation of induction.
measure: Neonatal complications and outcome.
time frame: Up to 5 days.
description: Any neonatal complications as mentioned In the neonate's electronic file.
arm group label: BMI>30+Dinoprostone
arm group type: Experimental
description: Women with a BMI>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
arm group label: BMI<30+Dinoprostone
arm group type: Experimental
description: Women with a BMI<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.
arm group label: BMI>30+Cervical ripening balloon
arm group type: Experimental
description: Women with a BMI>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
arm group label: BMI<30+Cervical ripening balloon
arm group type: Experimental
description: Women with a BMI<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.
intervention type: Drug
intervention name: Dinoprostone
description: 10 mg of a Dinoprostone vaginal insert.
arm group label: BMI<30+Dinoprostone
arm group label: BMI>30+Dinoprostone
other name: Prostaglandin E2
intervention type: Device
intervention name: Double lumen cervical ripening balloon.
description: Double lumen cervical ripening balloon.
arm group label: BMI<30+Cervical ripening balloon
arm group label: BMI>30+Cervical ripening balloon
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ROY LAUTERBACH, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: ROY LAUTERBACH MD
investigator title: Principal Investigator
mesh term: Dinoprostone
sharing ipd: No