<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/NCT03231904</url>
  </required_header>
  <id_info>
    <org_study_id>0508-16-RMB</org_study_id>
    <nct_id>NCT03231904</nct_id>
  </id_info>
  <brief_title>Maternal and Fetal Adrenocorticotropic Hormone (ACTH) and Leukemia Inhibitory Factor (LIF) and Gestational Age</brief_title>
  <official_title>The Correlation Between Gestational Age and Maternal and Fetal Levels of LIF and ACTH</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>
      In 2010, Simamura et al have demonstrated in a rat model that one of the pro-inflammatory&#xD;
      cytokine belonging to the Interleukin-6 family cytokines, LIF, is required for the&#xD;
      proliferation of neuronal progenitor cells in the cerebrum. They have shown that maternal LIF&#xD;
      induces ACTH from the placenta, which in turn stimulates fetal nucleated red blood cells to&#xD;
      secrete LIF, leading finally to neurogenesis in the fetus As demonstrated recently in a mouse&#xD;
      model, maternal inflammation suppress the physiological maternal- fetal LIF-ACTH-LIF signal,&#xD;
      result in reduction of ACTH production from placenta, which lead to a reduction in LIF&#xD;
      concentration in fetal Cerebrospinal fluid (CSF) and impaired proliferation of the neural&#xD;
      stem/ progenitor cells and poor development of the fetal brain.&#xD;
&#xD;
      In the current study, the investigators will take fetal and maternal blood samples of fetuses&#xD;
      undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the&#xD;
      routine blood samples before performance of TOP , fetal blood samples will be acquired from&#xD;
      the umbilical vessel after the termination has been completed , the blood samples will be&#xD;
      analyzed for levels of LIF and ACTH and checked according to termination pregnancy week,&#xD;
      Patients electronic files will be checked for relevant demographic and obstetric information.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study protocol:&#xD;
&#xD;
      In the current study, the investigators will take fetal and maternal blood samples of fetuses&#xD;
      undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the&#xD;
      routine blood samples before performance of TOP , fetal blood samples will be acquired from&#xD;
      the umbilical vessel after the termination has been completed , the blood samples will be&#xD;
      analyzed for levels of LIF and ACTH and checked according to termination pregnancy week,&#xD;
      Patients electronic files will be checked for relevant demographic and obstetric information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 10, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2017</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>Maternal LIF levels during pregnancy</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Differences in levels of LIF according to gestational age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal ACTH levels during pregnancy</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Differences in levels of ACTH according to gestational age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetal LIF levels during pregnancy</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Differences in levels of LIF according to gestational age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetal ACTH levels during pregnancy</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Differences in levels of ACTH according to gestational age</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Abortion, Legal</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>blood samples will be taken for maternal and fetal levels of ACTH and LIF</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      fetal and maternal blood samples for ACTH and LIF&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women undergoing termination of pregnancy for different reasons&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women undergoing termination of pregnancy in various gestational weeks.&#xD;
&#xD;
          -  Pregnant women undergoing spontaneous abortion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •Intrauterine fetal death.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women undergoing termination of pregnancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuval Ginsberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuval Ginsberg, MD</last_name>
    <phone>0523571199</phone>
    <email>y_ginsberg@rambam.health.gov.il</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 1, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Yuval Ginsberg, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03231904
org study id: 0508-16-RMB
nct id: NCT03231904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In 2010, Simamura et al have demonstrated in a rat model that one of the pro-inflammatory
      cytokine belonging to the Interleukin-6 family cytokines, LIF, is required for the
      proliferation of neuronal progenitor cells in the cerebrum. They have shown that maternal LIF
      induces ACTH from the placenta, which in turn stimulates fetal nucleated red blood cells to
      secrete LIF, leading finally to neurogenesis in the fetus As demonstrated recently in a mouse
      model, maternal inflammation suppress the physiological maternal- fetal LIF-ACTH-LIF signal,
      result in reduction of ACTH production from placenta, which lead to a reduction in LIF
      concentration in fetal Cerebrospinal fluid (CSF) and impaired proliferation of the neural
      stem/ progenitor cells and poor development of the fetal brain.

      In the current study, the investigators will take fetal and maternal blood samples of fetuses
      undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the
      routine blood samples before performance of TOP , fetal blood samples will be acquired from
      the umbilical vessel after the termination has been completed , the blood samples will be
      analyzed for levels of LIF and ACTH and checked according to termination pregnancy week,
      Patients electronic files will be checked for relevant demographic and obstetric information.
Study protocol:

      In the current study, the investigators will take fetal and maternal blood samples of fetuses
      undergoing termination of pregnancy (TOP) . Maternal samples will be acquired with the
      routine blood samples before performance of TOP , fetal blood samples will be acquired from
      the umbilical vessel after the termination has been completed , the blood samples will be
      analyzed for levels of LIF and ACTH and checked according to termination pregnancy week,
      Patients electronic files will be checked for relevant demographic and obstetric information.
observational model: Cohort
time perspective: Prospective
measure: Maternal LIF levels during pregnancy
time frame: up to 6 months
description: Differences in levels of LIF according to gestational age
measure: Maternal ACTH levels during pregnancy
time frame: up to 6 months
description: Differences in levels of ACTH according to gestational age
measure: Fetal LIF levels during pregnancy
time frame: up to 6 months
description: Differences in levels of LIF according to gestational age
measure: Fetal ACTH levels during pregnancy
time frame: up to 6 months
description: Differences in levels of ACTH according to gestational age
intervention type: Diagnostic Test
intervention name: Blood test
description: blood samples will be taken for maternal and fetal levels of ACTH and LIF
fetal and maternal blood samples for ACTH and LIF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women undergoing termination of pregnancy
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Yuval Ginsberg, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
last name: Yuval Ginsberg, MD
phone: 0523571199
email: y_ginsberg@rambam.health.gov.il
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Yuval Ginsberg, MD
investigator title: Principal Investigator
sharing ipd: No