<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/NCT02993744</url>
  </required_header>
  <id_info>
    <org_study_id>2130/2015</org_study_id>
    <nct_id>NCT02993744</nct_id>
  </id_info>
  <brief_title>Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone</brief_title>
  <official_title>Assessment of Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone Under Threat of Preterm Delivery</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>
      It is the aim of this study to detect the effect of Betamethasone on the maternal&#xD;
      inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under&#xD;
      threat of preterm delivery, for example because of a cervical infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND&#xD;
&#xD;
      Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because&#xD;
      of that, it is difficult to know if the medical treatment of an infection was successful and&#xD;
      accordingly if the diagnosis was justified.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      In this study, the blood results of 75 pregnant women under threat of preterm delivery (week&#xD;
      of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women&#xD;
      without complications serve as control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 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>CRP</measure>
    <time_frame>48h</time_frame>
    <description>The CRP values in mg/dL before and 48h after the first Betamethasone application</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leucocytes</measure>
    <time_frame>48h</time_frame>
    <description>The Leucocyte values in G/L before and 48h after the first Betamethasone application</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>Body Mass Index (BMI) in kg/m^2 is calculated to test for influence on inflammatory parameters in both groups (case and control)</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>Weight in kilogram (kg) is taken from the medical record to calculate the BMI in both groups (case and control)</description>
  </other_outcome>
  <other_outcome>
    <measure>Height</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>Size in meters (m) is taken from the medical record to calculate the BMI in both groups (case and control)</description>
  </other_outcome>
  <other_outcome>
    <measure>CRP Control Group</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>CRP values in mg/dL of patients belonging to the control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Leucocytes Control Group</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>Leucocyte values in G/L of patients belonging to the control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients with Allergies</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>information about the patients allergie status (allergies yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients with Diabetes</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>information about the patients diabetes status (diabetes yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)</description>
  </other_outcome>
  <other_outcome>
    <measure>Smoking Habits</measure>
    <time_frame>single point in the time frame between week of gestation 23+0 - 34+6, no fixed day</time_frame>
    <description>information about the patients smoking status (smoking yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Case Group</arm_group_label>
    <description>75 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, threatening preterm delivery, application of Betamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>65 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, no threatening preterm delivery</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      - blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant woman admitted to the department of feto-maternal health and obstetrics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  week of gestation 23+0 until 34+6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infectious diseases f.e. hepatitis B or C, HIV&#xD;
&#xD;
          -  diseases of the thyroid gland&#xD;
&#xD;
             75 Patients facing preterm labour 65 Patients acting as a control group, without&#xD;
             preterm labor&#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>Maria Kastanek</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Florian Frommlet, DI. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 25, 2017</last_update_submitted>
  <last_update_submitted_qc>May 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Kastanek Maria</investigator_full_name>
    <investigator_title>Student</investigator_title>
  </responsible_party>
  <keyword>preterm birth</keyword>
  <keyword>corticosteroids</keyword>
  <keyword>inflammatory parameters</keyword>
  <keyword>betamethasone</keyword>
  <keyword>leukocytes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT02993744
org study id: 2130/2015
nct id: NCT02993744
lead sponsor: 
has dmc: No
It is the aim of this study to detect the effect of Betamethasone on the maternal
      inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under
      threat of preterm delivery, for example because of a cervical infection.
BACKGROUND

      Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because
      of that, it is difficult to know if the medical treatment of an infection was successful and
      accordingly if the diagnosis was justified.

      METHODS

      In this study, the blood results of 75 pregnant women under threat of preterm delivery (week
      of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women
      without complications serve as control group.
observational model: Cohort
time perspective: Prospective
measure: CRP
time frame: 48h
description: The CRP values in mg/dL before and 48h after the first Betamethasone application
measure: Leucocytes
time frame: 48h
description: The Leucocyte values in G/L before and 48h after the first Betamethasone application
measure: Body Mass Index (BMI)
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: Body Mass Index (BMI) in kg/m^2 is calculated to test for influence on inflammatory parameters in both groups (case and control)
measure: Weight
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: Weight in kilogram (kg) is taken from the medical record to calculate the BMI in both groups (case and control)
measure: Height
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: Size in meters (m) is taken from the medical record to calculate the BMI in both groups (case and control)
measure: CRP Control Group
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: CRP values in mg/dL of patients belonging to the control group
measure: Leucocytes Control Group
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: Leucocyte values in G/L of patients belonging to the control group
measure: Patients with Allergies
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: information about the patients allergie status (allergies yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)
measure: Patients with Diabetes
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: information about the patients diabetes status (diabetes yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)
measure: Smoking Habits
time frame: single point in the time frame between week of gestation 23+0 - 34+6, no fixed day
description: information about the patients smoking status (smoking yes or no) is taken from the medical record to test for influence on inflammatory parameters in both groups (case and control)
arm group label: Case Group
description: 75 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, threatening preterm delivery, application of Betamethasone
arm group label: Control Group
description: 65 woman between the age of 18 to 50 years, week of gestation 23+0 - 34+6, no threatening preterm delivery
- blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Maria Kastanek
role: Principal Investigator
affiliation: Medical University Vienna
last name: Florian Frommlet, DI. Dr.
role: Study Chair
affiliation: Medical University Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Kastanek Maria
investigator title: Student
mesh term: Premature Birth
sharing ipd: No