<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/NCT03788863</url>
  </required_header>
  <id_info>
    <org_study_id>20638</org_study_id>
    <nct_id>NCT03788863</nct_id>
  </id_info>
  <brief_title>A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis</brief_title>
  <official_title>Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>LEO Pharma</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>
      Glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the&#xD;
      blood, and reduce inflammation. By applying a statistical technique for combining the&#xD;
      findings from a systematic literature review (meta analysis), researchers want to learn more&#xD;
      about the relationship of the risk to develop a separation in the roof of the mouth (cleft&#xD;
      palate) in newborns and contact with glucocorticoids during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2018</start_date>
  <completion_date type="Actual">November 29, 2018</completion_date>
  <primary_completion_date type="Actual">November 29, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of any type of orofacial cleft</measure>
    <time_frame>Retrospective analysis from 1-Jan-1997 to 25-Jun-2018</time_frame>
    <description>Meta-analysis will be conducted with 18 observational studies. Oral clefts are defined as diagnosis of cleft lip with or without cleft palate or isolated cleft palate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Potency (mild, moderate, potent, very potent) of glucocorticosteroids</measure>
    <time_frame>Retrospective analysis from 1-Jan-1997 to 25-Jun-2018</time_frame>
    <description>Potency of glucocorticoid&#xD;
Mild&#xD;
Moderate&#xD;
Potent&#xD;
Very potent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Route of administration of glucocorticosteroids</measure>
    <time_frame>Retrospective analysis from 1-Jan-1997 to 25-Jun-2018</time_frame>
    <description>Route of administration:&#xD;
Topical&#xD;
Systemic&#xD;
Any other form of use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of orofacial cleft</measure>
    <time_frame>Retrospective analysis from 1-Jan-1997 to 25-Jun-2018</time_frame>
    <description>Types of orofacial cleft&#xD;
Cleft lip (CP)&#xD;
Cleft lip with or without palate (CLP)&#xD;
Cleft palate (CP)&#xD;
Orofacial cleft (OC)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">99999</enrollment>
  <condition>Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development</condition>
  <arm_group>
    <arm_group_label>Pregnant women exposed to glucocorticoids</arm_group_label>
    <description>Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-exposed pregnant women</arm_group_label>
    <description>Women not using any glucocorticoid or corticosteroid or steroids during pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diflucortolone valerate (BAY866146)</intervention_name>
    <description>Follow clinical administration</description>
    <arm_group_label>Pregnant women exposed to glucocorticoids</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early&#xD;
        pregnancy or first trimester of pregnancy irrespective of mode of administration identified&#xD;
        through a systematic review of articles published up to 25 June 2018 by pre-specified&#xD;
        inclusion and exclusion criteria. In total 18 observational studies have been selected for&#xD;
        this meta-analysis with sample size for individual studies ranging from 106 to 832,636&#xD;
        patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Population: Pregnant women&#xD;
&#xD;
          -  Intervention: Any glucocorticoid or corticosteroid or steroids use irrespective of&#xD;
             mode of administration&#xD;
&#xD;
          -  Comparator: Any/none&#xD;
&#xD;
          -  Outcomes: Incidence/ risk of cleft lip/palate in infants&#xD;
&#xD;
          -  Study Design:&#xD;
&#xD;
               -  Meta-analysis and systematic literature reviews&#xD;
&#xD;
               -  Observational studies (such as cohort study, case-control study, registries data)&#xD;
&#xD;
               -  Clinical trials - Phase IIb, III, and IV&#xD;
&#xD;
               -  Conference abstracts/posters&#xD;
&#xD;
          -  Time period: No time period restriction&#xD;
&#xD;
          -  Geography: No geography restriction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Population: Nonpregnant women&#xD;
&#xD;
          -  Intervention: Drugs other than glucocorticoid or corticosteroid or steroid&#xD;
&#xD;
          -  Outcomes: Incidence/ risk of cleft lip/palate in infants&#xD;
&#xD;
          -  Study Design:&#xD;
&#xD;
               -  Animal Study&#xD;
&#xD;
               -  In vitro studies&#xD;
&#xD;
               -  Editorial, letters, comment&#xD;
&#xD;
               -  Clinical trials - Phase I or preclinical&#xD;
&#xD;
               -  Case reports, case series&#xD;
&#xD;
               -  Reviews&#xD;
&#xD;
          -  Studies focusing on:&#xD;
&#xD;
               -  Diagnosis and surgical procedure for cleft repair&#xD;
&#xD;
               -  Impact of Increased internal corticosteroids due to stress&#xD;
&#xD;
               -  The relationship between genetic mutations and cleft patients&#xD;
&#xD;
               -  Adverse events for other drugs&#xD;
&#xD;
               -  Safety profiles of glucocorticoid or corticosteroid&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diflucortolone</mesh_term>
    <mesh_term>Diflucortolone valerate</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/NCT03788863
org study id: 20638
nct id: NCT03788863
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the
      blood, and reduce inflammation. By applying a statistical technique for combining the
      findings from a systematic literature review (meta analysis), researchers want to learn more
      about the relationship of the risk to develop a separation in the roof of the mouth (cleft
      palate) in newborns and contact with glucocorticoids during pregnancy.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of any type of orofacial cleft
time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
description: Meta-analysis will be conducted with 18 observational studies. Oral clefts are defined as diagnosis of cleft lip with or without cleft palate or isolated cleft palate.
measure: Potency (mild, moderate, potent, very potent) of glucocorticosteroids
time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
description: Potency of glucocorticoid
Mild
Moderate
Potent
Very potent
measure: Route of administration of glucocorticosteroids
time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
description: Route of administration:
Topical
Systemic
Any other form of use
measure: Types of orofacial cleft
time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
description: Types of orofacial cleft
Cleft lip (CP)
Cleft lip with or without palate (CLP)
Cleft palate (CP)
Orofacial cleft (OC)
arm group label: Pregnant women exposed to glucocorticoids
description: Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy
arm group label: Non-exposed pregnant women
description: Women not using any glucocorticoid or corticosteroid or steroids during pregnancy
intervention type: Drug
intervention name: Diflucortolone valerate (BAY866146)
description: Follow clinical administration
arm group label: Pregnant women exposed to glucocorticoids
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Diflucortolone
mesh term: Diflucortolone valerate