<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/NCT03007186</url>
  </required_header>
  <id_info>
    <org_study_id>1102/2016</org_study_id>
    <nct_id>NCT03007186</nct_id>
  </id_info>
  <brief_title>Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus</brief_title>
  <official_title>Glucose Monitoring During Threatening Preterm Birth With Particular Focus on Insulin Sensitivity and Glucose Tolerance in Patients With and Without Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to show whether the hyperglycaemic phases following a treatment with&#xD;
      glucocorticoids, as well as blood measurements correlated to high blood glucose levels and&#xD;
      insulin resistance, vary significantly between patients with and without gestational diabetes&#xD;
      mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm&#xD;
      birth is an long existing part of the obstetric routine procedures. Under this therapy it&#xD;
      should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin&#xD;
      sensitivity as well as they can cause an impaired maternal glucose tolerance.&#xD;
&#xD;
      Therefore a threatening preterm birth as well as the including medical therapy do challenge&#xD;
      the glucose metabolism of mother and child.&#xD;
&#xD;
      Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy,&#xD;
      and the numbers are on the rise. GDM is characterized through an insulin resistance during&#xD;
      the pregnancy.&#xD;
&#xD;
      High blood glucose level during pregnancy or labour can cause complications like a fetal&#xD;
      hypoglycaemia right after birth.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      This study includes pregnant women with and without gestational diabetes who are medicated&#xD;
      with betamethasone due to threatening preterm birth.&#xD;
&#xD;
      In this study the blood glucose measurements of one week, as well as the measurements of&#xD;
      HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy&#xD;
      will be considered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 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>Blood glucose measurements</measure>
    <time_frame>Seven days after betamethasone medication.</time_frame>
    <description>The patient measures their blood glucose level six times a day for seven days. The times of the measurements are before and one hour after every meal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>One week after the medication with Betamethasone for lung maturation.</time_frame>
    <description>HbA1C measurements from a blood draw of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Glucose Level</measure>
    <time_frame>One week after the medication with Betamethasone for lung maturation.</time_frame>
    <description>Blood glucose level measurements from a blood draw of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin level</measure>
    <time_frame>One week after the medication with Betamethasone for lung maturation.</time_frame>
    <description>Insulin level measurements from a blood draw of the patient.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age of the patient in years</measure>
    <time_frame>At the day of the medication with betamethasone</time_frame>
    <description>Age of the patient in years</description>
  </other_outcome>
  <other_outcome>
    <measure>Result of oral glucose tolerance test</measure>
    <time_frame>The test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestation</time_frame>
    <description>Mandatory test in the Austrian Mother-Child-Pass. The data will be collected at the day of the medication with betamethasone.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetes, Gestational</condition>
  <condition>Insulin Sensitivity</condition>
  <condition>PreTerm Birth</condition>
  <condition>Glucose Intolerance During Pregnancy</condition>
  <condition>Glucocorticoids</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <description>The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The oral glucose tolerance test of these women showed no pathological measurements.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All participating patients will be pregnant women with a threatening preterm birth admitted&#xD;
        to the department of feto-maternal health and obstetrics of the AKH Vienna.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  gestational age between 23+0 and 34+6&#xD;
&#xD;
          -  an oral glucose tolerance test was made and attests a healthy glucose tolerance&#xD;
             (control group) a gestational diabetes mellitus (case group)&#xD;
&#xD;
          -  threatening preterm birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missing consent to participate&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  age over 50 years&#xD;
&#xD;
          -  preexistent diabetes (type 1 or 2)&#xD;
&#xD;
          -  apparent disease of the thyroid gland&#xD;
&#xD;
          -  infectious diseases as HIV or Hepatitis C&#xD;
&#xD;
          -  insulin dependent gestational diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Goebl, MD</last_name>
    <role>Study Chair</role>
    <affiliation>AKH Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lara Linsenmeier, Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AKH (General Hospital of) Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Lara Linsenmeier</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Blood glucose monitoring</keyword>
  <keyword>Glucose tolerance</keyword>
  <keyword>HbA1C</keyword>
  <keyword>Insulin</keyword>
  <keyword>Betamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03007186
org study id: 1102/2016
nct id: NCT03007186
lead sponsor: 
has dmc: No
This study aims to show whether the hyperglycaemic phases following a treatment with
      glucocorticoids, as well as blood measurements correlated to high blood glucose levels and
      insulin resistance, vary significantly between patients with and without gestational diabetes
      mellitus.
BACKGROUND:

      The therapy with glucocorticoids for fetal lung maturation in the case of threatening preterm
      birth is an long existing part of the obstetric routine procedures. Under this therapy it
      should not be forgotten, that glucocorticoids can lead to a decrease of the maternal insulin
      sensitivity as well as they can cause an impaired maternal glucose tolerance.

      Therefore a threatening preterm birth as well as the including medical therapy do challenge
      the glucose metabolism of mother and child.

      Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy,
      and the numbers are on the rise. GDM is characterized through an insulin resistance during
      the pregnancy.

      High blood glucose level during pregnancy or labour can cause complications like a fetal
      hypoglycaemia right after birth.

      METHODS:

      This study includes pregnant women with and without gestational diabetes who are medicated
      with betamethasone due to threatening preterm birth.

      In this study the blood glucose measurements of one week, as well as the measurements of
      HbA1C, Insulin and Blood Glucose from a blood draw one week after the lung maturation therapy
      will be considered.
observational model: Cohort
time perspective: Prospective
measure: Blood glucose measurements
time frame: Seven days after betamethasone medication.
description: The patient measures their blood glucose level six times a day for seven days. The times of the measurements are before and one hour after every meal.
measure: HbA1C
time frame: One week after the medication with Betamethasone for lung maturation.
description: HbA1C measurements from a blood draw of the patient.
measure: Blood Glucose Level
time frame: One week after the medication with Betamethasone for lung maturation.
description: Blood glucose level measurements from a blood draw of the patient.
measure: Insulin level
time frame: One week after the medication with Betamethasone for lung maturation.
description: Insulin level measurements from a blood draw of the patient.
measure: Age of the patient in years
time frame: At the day of the medication with betamethasone
description: Age of the patient in years
measure: Result of oral glucose tolerance test
time frame: The test will be carried out during pregnancy between 24+0 and 28+0 weeks of gestation
description: Mandatory test in the Austrian Mother-Child-Pass. The data will be collected at the day of the medication with betamethasone.
arm group label: Case group
description: The oral glucose tolerance test that these women undergo in pregnancy between 24+0 and 28+0 showed pathological measurements.
arm group label: Control group
description: The oral glucose tolerance test of these women showed no pathological measurements.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Christian Goebl, MD
role: Study Chair
affiliation: AKH Vienna
last name: Lara Linsenmeier, Student
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Lara Linsenmeier
investigator title: Principal Investigator
mesh term: Premature Birth
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Insulin Resistance
mesh term: Glucose Intolerance
mesh term: Hypersensitivity
sharing ipd: No