<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/NCT03025503</url>
  </required_header>
  <id_info>
    <org_study_id>NippleStim-HMO-CTIL</org_study_id>
    <nct_id>NCT03025503</nct_id>
  </id_info>
  <brief_title>Nipple Stimulation for Labor Induction</brief_title>
  <official_title>Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the use of nipple stimulation for cervical ripening in women who&#xD;
      present to the labor and delivery ward after their water has broken but have a&#xD;
      contraindication to prostaglandins.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>progression to active labor as measured by the Bishop score</measure>
    <time_frame>6 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Delivery Delayed</condition>
  <arm_group>
    <arm_group_label>nipple stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nipple stimulation</intervention_name>
    <arm_group_label>nipple stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Week 37 + 0 and on&#xD;
&#xD;
          -  PROM (premature rupture of membranes)&#xD;
&#xD;
          -  Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)&#xD;
&#xD;
          -  Not in active labor - without regular contractions fetal monitor, cervical dilation &lt;&#xD;
             4 cm and effacement &lt; 80%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Water break &gt; 24 hours at the time of admission to the delivery room&#xD;
&#xD;
          -  Active vaginal bleeding with suspected placental abruption&#xD;
&#xD;
          -  Maternal fever&#xD;
&#xD;
          -  Multifetal pregnancy&#xD;
&#xD;
          -  Women with contraindication for vaginal birth&#xD;
&#xD;
          -  Preeclampsia&#xD;
&#xD;
          -  IUGR (intrauterine growth restriction)&#xD;
&#xD;
          -  Macrosomia&#xD;
&#xD;
          -  Non-reassuring fetal heart tracing&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Drorith Hochner-Celnikier, MD</last_name>
    <phone>00 972 2 5844400</phone>
    <email>hochner@hadassah.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hadassah Medical Organization, Jerusalem, Israel</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03025503
org study id: NippleStim-HMO-CTIL
nct id: NCT03025503
lead sponsor: 
has dmc: No
This study will examine the use of nipple stimulation for cervical ripening in women who
      present to the labor and delivery ward after their water has broken but have a
      contraindication to prostaglandins.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression to active labor as measured by the Bishop score
time frame: 6 hours
arm group label: nipple stimulation
arm group type: Experimental
arm group label: no intervention
arm group type: No Intervention
intervention type: Other
intervention name: nipple stimulation
arm group label: nipple stimulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Drorith Hochner-Celnikier, MD
phone: 00 972 2 5844400
email: hochner@hadassah.org.il
facility: 
country: Israel
responsible party type: Sponsor
sharing ipd: Undecided