<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/NCT04409678</url>
  </required_header>
  <id_info>
    <org_study_id>0112-19-womc</org_study_id>
    <nct_id>NCT04409678</nct_id>
  </id_info>
  <brief_title>Physical Activity and Preterm Birth With Cervical Dynamics</brief_title>
  <official_title>Influence of Physical Activity on Preterm Birth for Women With Cervical Dynamics</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      this RCT is designed to investigate the influence of physical activity on the risk f preterm&#xD;
      birth for women with cervical dynamics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Anticipated">May 26, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 26, 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>preterm birth</measure>
    <time_frame>assessed from recruitment to delivery</time_frame>
    <description>birth prior to 37 weeks of gestation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>bed rest</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>activity</intervention_name>
    <description>physical activity</description>
    <arm_group_label>activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        pregnant women between 24-34 weeks of gestation singleton cervical length&lt;25 mm willing to&#xD;
        download an application which traces physical activity on medical indication for reducing&#xD;
        activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        refusal to participate medical advise to minimize activity (symphysiolysis) maternal&#xD;
        morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins&#xD;
        pregnancy&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yakira Izaik, Doctor</last_name>
    <phone>972545533462</phone>
    <email>yakyuk@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>edith wolfsom MC</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yakira izaik, doctor</last_name>
      <phone>972545533462</phone>
      <email>yakyuk@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Yakira</investigator_full_name>
    <investigator_title>Dr Izaik Yakira</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT04409678
org study id: 0112-19-womc
nct id: NCT04409678
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
this RCT is designed to investigate the influence of physical activity on the risk f preterm
      birth for women with cervical dynamics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: preterm birth
time frame: assessed from recruitment to delivery
description: birth prior to 37 weeks of gestation
arm group label: activity
arm group type: Experimental
arm group label: bed rest
arm group type: No Intervention
intervention type: Behavioral
intervention name: activity
description: physical activity
arm group label: activity
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: No
last name: Yakira Izaik, Doctor
phone: 972545533462
email: yakyuk@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Yakira
investigator title: Dr Izaik Yakira
mesh term: Premature Birth