<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/NCT03021837</url>
  </required_header>
  <id_info>
    <org_study_id>21014a</org_study_id>
    <nct_id>NCT03021837</nct_id>
    <nct_alias>NCT02912091</nct_alias>
  </id_info>
  <brief_title>The Effect of Steroids on Maternal Glucose Levels</brief_title>
  <official_title>The Effect of Steroids for Fetal Lung Maturity on Maternal Glucose Levels</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at blood sugar levels in pregnant women who have been given a&#xD;
      glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help&#xD;
      determine the likelihood, predictive value, adverse effects, response of patients diagnosed&#xD;
      with gestational diabetes and time course of blood sugar elevation following steroids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few studies have examined the effects on maternal glucose levels from corticosteroids, which&#xD;
      are given during some complicated pregnancies to enhance fetal lung maturity when early&#xD;
      delivery is expected. The applicability of these studies is limited by the presence of&#xD;
      confounding factors and low numbers of participants (ranging between 7 and 50). Two relevant&#xD;
      studies are by Mastrobiattista at al and Gurbuz et al. These studies had 7 and 40 subjects&#xD;
      respectively, and studied the change in maternal 1-hour glucose tolerance tests following&#xD;
      administration of steroids for fetal lung maturity. The 1-hour tests involve a standard oral&#xD;
      glucose challenge and are used to screen for gestational diabetes; thus, they may not reflect&#xD;
      the changes in circulating glucose levels from typical sources of glucose (such as meals)&#xD;
      anticipated with steroid administration. Both studies showed a change in the results of&#xD;
      glucose tolerance testing and concluded that screening for gestational diabetes should be&#xD;
      delayed at least 72 hours to 1 week after completion of the steroid course. Neither study&#xD;
      looked at maternal glucose values within the first 48 hours of giving the first dose of&#xD;
      steroids, and neither addressed whether diabetes could be diagnosed alternatively by the&#xD;
      maternal glucose response within the first 48 hours following steroid administration.&#xD;
&#xD;
      It has been the investigator's clinical observation that glucose values may be highest during&#xD;
      those first 48 hours. Another study looked at the effect of various doses of insulin on the&#xD;
      degree of hyperglycemia for the first 3 days following steroid administration and showed&#xD;
      increases in glucose values even in the insulin-treated. Unfortunately, some subjects in that&#xD;
      study had concurrent treatment with another agent known to cause hyperglycemia.&#xD;
&#xD;
      No standards of care exist to guide whether to monitor glucose values after steroid&#xD;
      administration for fetal lung maturity. The time course of glucose elevations is not clear,&#xD;
      and how often the glucose elevations reach a level that would generally warrant treatment is&#xD;
      unknown. When glucose monitoring is performed, no standard exists to guide the duration or&#xD;
      frequency of monitoring.&#xD;
&#xD;
      Detecting maternal hyperglycemia is important for several reasons, including:&#xD;
&#xD;
        1. High maternal glucose levels lead to high fetal levels and prompt a fetal response to&#xD;
           the high glucose levels. Some of the pregnancies may go on to deliver while the maternal&#xD;
           glucose levels are still high, resulting in a higher risk of neonatal hypoglycemia in&#xD;
           the nursery and an increased risk of acidosis and injury in the brain if periods of&#xD;
           distress occur during labor. By the nature of the clinical situations, most fetuses born&#xD;
           in the first few days following administration of steroids will also be preterm and&#xD;
           possibly already have additional factors which put them at risk for complications in&#xD;
           labor and the nursery, so the hyperglycemia compounds the risk for them.&#xD;
&#xD;
        2. The maternal hyperglycemia may complicate the maternal course at a time when the&#xD;
           pregnant woman is receiving other medications to control her premature labor or&#xD;
           obstetric condition that prompted the use of the steroids in the first place. Fluid&#xD;
           balance and constitutional symptoms may be affected by high glucose values. Rarely,&#xD;
           diabetic ketoacidosis may be precipitated in someone with no history of diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2012</start_date>
  <completion_date type="Actual">March 17, 2015</completion_date>
  <primary_completion_date type="Actual">March 17, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The length of time that maternal glucose levels remain elevated after steroid administration.</measure>
    <time_frame>6 hours</time_frame>
    <description>Time until glucose levels return to baseline</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>all patients</arm_group_label>
    <description>Patient receiving antenatal corticosteroid course for fetal lung maturity consisting of betamethasone or dexamethasone Women without known gestational diabetes and women with non-insulin requiring gestational diabetes (A1GDM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>antenatal corticosteroid</intervention_name>
    <description>Will look at maternal glucose level after corticosteroids</description>
    <arm_group_label>all patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant patients, who meet Inclusion/exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intrauterine pregnancy at 22 weeks to 36 weeks gestation at time of steroid&#xD;
             administration&#xD;
&#xD;
          -  Singleton&#xD;
&#xD;
          -  Patient receiving antenatal corticosteroid course for fetal lung maturity consisting&#xD;
             of betamethasone or dexamethasone&#xD;
&#xD;
          -  Age range: 14yo-50yo&#xD;
&#xD;
          -  Women without known gestational diabetes and women with non-insulin requiring&#xD;
             gestational diabetes (A1GDM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with known gestational diabetes (diagnosed before steroid administration) that&#xD;
             has required insulin or other medical therapy to control&#xD;
&#xD;
          -  Women with overt diabetes which predates pregnancy.&#xD;
&#xD;
          -  Chronic terbutaline therapy or other concurrent chronic beta-adrenergic agonist use&#xD;
&#xD;
          -  Patients on parenteral or oral corticosteroids for reasons other than to improve fetal&#xD;
             lung maturity&#xD;
&#xD;
          -  Multiple gestation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dorothea Mostello, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>November 20, 2017</last_update_submitted>
  <last_update_submitted_qc>November 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Dorothea Mostello, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</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/NCT03021837
org study id: 21014a
nct id: NCT03021837
nct alias: NCT02912091
lead sponsor: 
has dmc: No
This study will look at blood sugar levels in pregnant women who have been given a
      glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help
      determine the likelihood, predictive value, adverse effects, response of patients diagnosed
      with gestational diabetes and time course of blood sugar elevation following steroids.
Few studies have examined the effects on maternal glucose levels from corticosteroids, which
      are given during some complicated pregnancies to enhance fetal lung maturity when early
      delivery is expected. The applicability of these studies is limited by the presence of
      confounding factors and low numbers of participants (ranging between 7 and 50). Two relevant
      studies are by Mastrobiattista at al and Gurbuz et al. These studies had 7 and 40 subjects
      respectively, and studied the change in maternal 1-hour glucose tolerance tests following
      administration of steroids for fetal lung maturity. The 1-hour tests involve a standard oral
      glucose challenge and are used to screen for gestational diabetes; thus, they may not reflect
      the changes in circulating glucose levels from typical sources of glucose (such as meals)
      anticipated with steroid administration. Both studies showed a change in the results of
      glucose tolerance testing and concluded that screening for gestational diabetes should be
      delayed at least 72 hours to 1 week after completion of the steroid course. Neither study
      looked at maternal glucose values within the first 48 hours of giving the first dose of
      steroids, and neither addressed whether diabetes could be diagnosed alternatively by the
      maternal glucose response within the first 48 hours following steroid administration.

      It has been the investigator's clinical observation that glucose values may be highest during
      those first 48 hours. Another study looked at the effect of various doses of insulin on the
      degree of hyperglycemia for the first 3 days following steroid administration and showed
      increases in glucose values even in the insulin-treated. Unfortunately, some subjects in that
      study had concurrent treatment with another agent known to cause hyperglycemia.

      No standards of care exist to guide whether to monitor glucose values after steroid
      administration for fetal lung maturity. The time course of glucose elevations is not clear,
      and how often the glucose elevations reach a level that would generally warrant treatment is
      unknown. When glucose monitoring is performed, no standard exists to guide the duration or
      frequency of monitoring.

      Detecting maternal hyperglycemia is important for several reasons, including:

        1. High maternal glucose levels lead to high fetal levels and prompt a fetal response to
           the high glucose levels. Some of the pregnancies may go on to deliver while the maternal
           glucose levels are still high, resulting in a higher risk of neonatal hypoglycemia in
           the nursery and an increased risk of acidosis and injury in the brain if periods of
           distress occur during labor. By the nature of the clinical situations, most fetuses born
           in the first few days following administration of steroids will also be preterm and
           possibly already have additional factors which put them at risk for complications in
           labor and the nursery, so the hyperglycemia compounds the risk for them.

        2. The maternal hyperglycemia may complicate the maternal course at a time when the
           pregnant woman is receiving other medications to control her premature labor or
           obstetric condition that prompted the use of the steroids in the first place. Fluid
           balance and constitutional symptoms may be affected by high glucose values. Rarely,
           diabetic ketoacidosis may be precipitated in someone with no history of diabetes.
observational model: Other
time perspective: Retrospective
measure: The length of time that maternal glucose levels remain elevated after steroid administration.
time frame: 6 hours
description: Time until glucose levels return to baseline
arm group label: all patients
description: Patient receiving antenatal corticosteroid course for fetal lung maturity consisting of betamethasone or dexamethasone Women without known gestational diabetes and women with non-insulin requiring gestational diabetes (A1GDM)
intervention type: Other
intervention name: antenatal corticosteroid
description: Will look at maternal glucose level after corticosteroids
arm group label: all patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 50 Years
healthy volunteers: No
last name: Dorothea Mostello, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Dorothea Mostello, MD
investigator title: Principal Investigator
mesh term: Diabetes, Gestational
sharing ipd: No