<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/NCT01697098</url>
  </required_header>
  <id_info>
    <org_study_id>Dexa WHH</org_study_id>
    <nct_id>NCT01697098</nct_id>
  </id_info>
  <brief_title>Dexamethasone for Preterm Labour</brief_title>
  <acronym>PTL</acronym>
  <official_title>Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators sought to determine whether the incidence of neonatal respiratory distress&#xD;
      syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of&#xD;
      dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The administration of glucocorticoids to accelerate fetal lung maturity in patients with&#xD;
      preterm delivery plays an important role for obstetrics and neonatal care. Many studies have&#xD;
      shown that maternal administration of glucocorticoids has a significant beneficial effect in&#xD;
      decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34&#xD;
      weeks of gestation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>respiratory distress syndrome (RDS)</measure>
    <time_frame>6 month</time_frame>
    <description>determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of dexamethasone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perinatal mortality</measure>
    <time_frame>6 month</time_frame>
    <description>Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Neonatal intensive care</measure>
    <time_frame>6 month</time_frame>
    <description>Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Prematurity</condition>
  <arm_group>
    <arm_group_label>12 hours Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those patient will be given 12 hours dexamethasone after randomization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>24 hours Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those patient will be give 24 hours dexamethasone after randomization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone 24 hours</intervention_name>
    <arm_group_label>24 hours Dexamethasone</arm_group_label>
    <other_name>glucocorticoids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone 12</intervention_name>
    <arm_group_label>12 hours Dexamethasone</arm_group_label>
    <other_name>glucocorticoids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patient with threatened or established preterm labor between 28 - 34 weeks&#xD;
             attended to our emergency unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergent obstetric conditions like:&#xD;
&#xD;
               -  Antepartum hemorrhage in severe attack&#xD;
&#xD;
               -  Antepartum eclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Women Health Hospital</investigator_title>
  </responsible_party>
  <keyword>Dexamethasone</keyword>
  <keyword>preterm labour</keyword>
  <keyword>respiratory distress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Glucocorticoids</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01697098
org study id: Dexa WHH
nct id: NCT01697098
lead sponsor: 
has dmc: Yes
The investigators sought to determine whether the incidence of neonatal respiratory distress
      syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of
      dexamethasone.
The administration of glucocorticoids to accelerate fetal lung maturity in patients with
      preterm delivery plays an important role for obstetrics and neonatal care. Many studies have
      shown that maternal administration of glucocorticoids has a significant beneficial effect in
      decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34
      weeks of gestation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: respiratory distress syndrome (RDS)
time frame: 6 month
description: determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of dexamethasone.
measure: Perinatal mortality
time frame: 6 month
description: Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.
measure: Neonatal intensive care
time frame: 6 month
description: Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.
arm group label: 12 hours Dexamethasone
arm group type: Experimental
description: Those patient will be given 12 hours dexamethasone after randomization
arm group label: 24 hours Dexamethasone
arm group type: Experimental
description: Those patient will be give 24 hours dexamethasone after randomization
intervention type: Drug
intervention name: Dexamethasone 24 hours
arm group label: 24 hours Dexamethasone
other name: glucocorticoids
intervention type: Drug
intervention name: Dexamethasone 12
arm group label: 12 hours Dexamethasone
other name: glucocorticoids
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Women Health Hospital
mesh term: Premature Birth
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Glucocorticoids
mesh term: BB 1101