<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/NCT03784092</url>
  </required_header>
  <id_info>
    <org_study_id>0201-18-womc</org_study_id>
    <nct_id>NCT03784092</nct_id>
  </id_info>
  <brief_title>Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial</brief_title>
  <official_title>The Effect of Enhanced Mobility, Controlled Via Electronic Pedometers, During Induction of Labor by Extra Amniotic Balloon on Time to Delivery. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</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>
      this is a andomized controlled trial the evaluates the effect of enhanced mobility,&#xD;
      controlled via electronic pedometers, during induction of labor by extra amniotic balloon on&#xD;
      time to delivery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to delivery</measure>
    <time_frame>labor ( catheter placement till delivery completion)</time_frame>
    <description>time from extra amniotic catheter placement till delivery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Labor Onset and Length Abnormalities</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>feedback</intervention_name>
    <description>feedback by electronic pedometers regarding patient mobility while undergoing labor induction</description>
    <arm_group_label>feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  low risk pregnancies&#xD;
&#xD;
          -  singlelton&#xD;
&#xD;
          -  vertex position&#xD;
&#xD;
          -  undergoing labor induction with extra amniotic catheter&#xD;
&#xD;
          -  no contraindication for enhanced mobility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medical recommendation for limited mobility&#xD;
&#xD;
          -  status post cesarean delivery&#xD;
&#xD;
          -  twin pregnancy&#xD;
&#xD;
          -  premature rupture of membranes&#xD;
&#xD;
          -  severe preeclampsia&#xD;
&#xD;
          -  maternal comorbidity&#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>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Noa Gonen</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_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/NCT03784092
org study id: 0201-18-womc
nct id: NCT03784092
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
this is a andomized controlled trial the evaluates the effect of enhanced mobility,
      controlled via electronic pedometers, during induction of labor by extra amniotic balloon on
      time to delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: time to delivery
time frame: labor ( catheter placement till delivery completion)
description: time from extra amniotic catheter placement till delivery
arm group label: control
arm group type: No Intervention
arm group label: feedback
arm group type: Experimental
intervention type: Other
intervention name: feedback
description: feedback by electronic pedometers regarding patient mobility while undergoing labor induction
arm group label: feedback
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Noa Gonen
investigator title: principal investigator
mesh term: Congenital Abnormalities
sharing ipd: No