<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/NCT04416022</url>
  </required_header>
  <id_info>
    <org_study_id>0711-19-RMB</org_study_id>
    <nct_id>NCT04416022</nct_id>
  </id_info>
  <brief_title>Cervical Gland Area as a Predictor of Success of Labour Induction</brief_title>
  <official_title>Cervical Gland Area as a Predictor of Success of Labour Induction</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 who fulfil the inclusion criteria and who are planned for labour induction will be&#xD;
      recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA)&#xD;
      will be documented for every patient up to 12 hours prior to the induction process, and&#xD;
      patient information and maternal and neonatal outcome will be documented following the&#xD;
      delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient consent to participate in the study will be retrieved following the medical decision&#xD;
      of labor induction and the mode of induction and following the patient consent to the&#xD;
      induction.&#xD;
&#xD;
      Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be&#xD;
      documented for every patient up to 12 hours prior to the induction process.&#xD;
&#xD;
      The method of induction, data regarding patient demographics, the progress of labor, and the&#xD;
      maternal and neonatal outcome will be documented following the delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 7, 2020</start_date>
  <completion_date type="Anticipated">June 7, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 7, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Onset of active labour</measure>
    <time_frame>Up to delivery</time_frame>
    <description>Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from Induction to second stage</measure>
    <time_frame>Up to delivery</time_frame>
    <description>Duration of time from initiation of labpur induction to cervical dilation of 10cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from Induction to delivery</measure>
    <time_frame>Up to delivery</time_frame>
    <description>Duration of time from initiation of labpur induction to delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of vaginal delivery</measure>
    <time_frame>Up to delivery</time_frame>
    <description>The rate of patient that deliver vaginally including instrumental deliverires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcome - PH</measure>
    <time_frame>Up to 10 minutes from delivery</time_frame>
    <description>The fetal arterial pH measuerment following the delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)</measure>
    <time_frame>Up to 5 minutes from delivery</time_frame>
    <description>The fetal APGAR score as recieved by pediatrician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission</measure>
    <time_frame>Up to 48 hours from delivery</time_frame>
    <description>Percent of neonated that requiered NICU admission</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Induced Vaginal Delivery</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound examination</intervention_name>
    <description>Women that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who are planned form labour induction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton and twins' pregnancies&#xD;
&#xD;
          -  Pregnancy 34-41 weeks of gestation&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Induction methods (Oxytocin, prostaglandin 1 (PGE1), prostaglandin 2 (PGE2), double&#xD;
             balloon catheter, rupture of memebrane (ROM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intrauterine fetal demise (IUFD)&#xD;
&#xD;
          -  Contraindication to vaginal delivery&#xD;
&#xD;
          -  Status post cervical cerclage&#xD;
&#xD;
          -  Previous attempt of labor induction&#xD;
&#xD;
          -  History of cervical surgery&#xD;
&#xD;
          -  Active vaginal bleeding&#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>Saar Aharoni, M.D</last_name>
    <phone>+ 523395351</phone>
    <email>s_aharoni@rambam.health.gov.il</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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>SAAR AHARONI MD</investigator_full_name>
    <investigator_title>Dr. Saar Aharoni</investigator_title>
  </responsible_party>
  <keyword>Labour induction</keyword>
  <keyword>Cervical glandular area</keyword>
  <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/NCT04416022
org study id: 0711-19-RMB
nct id: NCT04416022
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Women who fulfil the inclusion criteria and who are planned for labour induction will be
      recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA)
      will be documented for every patient up to 12 hours prior to the induction process, and
      patient information and maternal and neonatal outcome will be documented following the
      delivery.
Patient consent to participate in the study will be retrieved following the medical decision
      of labor induction and the mode of induction and following the patient consent to the
      induction.

      Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be
      documented for every patient up to 12 hours prior to the induction process.

      The method of induction, data regarding patient demographics, the progress of labor, and the
      maternal and neonatal outcome will be documented following the delivery.
observational model: Cohort
time perspective: Prospective
measure: Onset of active labour
time frame: Up to delivery
description: Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)
measure: Time from Induction to second stage
time frame: Up to delivery
description: Duration of time from initiation of labpur induction to cervical dilation of 10cm
measure: Time from Induction to delivery
time frame: Up to delivery
description: Duration of time from initiation of labpur induction to delivery
measure: Rate of vaginal delivery
time frame: Up to delivery
description: The rate of patient that deliver vaginally including instrumental deliverires
measure: Neonatal outcome - PH
time frame: Up to 10 minutes from delivery
description: The fetal arterial pH measuerment following the delivery
measure: Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)
time frame: Up to 5 minutes from delivery
description: The fetal APGAR score as recieved by pediatrician
measure: Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission
time frame: Up to 48 hours from delivery
description: Percent of neonated that requiered NICU admission
intervention type: Diagnostic Test
intervention name: Ultrasound examination
description: Women that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Saar Aharoni, M.D
phone: + 523395351
email: s_aharoni@rambam.health.gov.il
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: SAAR AHARONI MD
investigator title: Dr. Saar Aharoni
sharing ipd: Undecided