<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/NCT03251794</url>
  </required_header>
  <id_info>
    <org_study_id>FAGE</org_study_id>
    <nct_id>NCT03251794</nct_id>
  </id_info>
  <brief_title>Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor</brief_title>
  <official_title>Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor</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>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>
      Preterm birth continues to be a major public health problem with lasting family and societal&#xD;
      repercussions. Despite tremendous research effort, prevention strategies have failed, and the&#xD;
      prevalence of preterm birth in the United States reached 12.3% in 2003.&#xD;
&#xD;
      Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at &lt; 37 weeks'&#xD;
      gestation. The rate of prematurity increases dramatically with the number of fetuses -&#xD;
      singletons 10%; twins 54.9%; and triplets 93.6%&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">April 18, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the volume of adrenal gland</measure>
    <time_frame>5 minutes</time_frame>
    <description>measurement by three dimensional ultrasound</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Preterm Labor</condition>
  <arm_group>
    <arm_group_label>threatened preterm labor</arm_group_label>
    <description>women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>three dimensional ultrasound</intervention_name>
    <description>evaluation of the suprarenal glands</description>
    <arm_group_label>threatened preterm labor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>color Doppler</intervention_name>
    <description>Doppler evaluation of the suprarenal artery</description>
    <arm_group_label>threatened preterm labor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women with threatened preterm labor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. singleton fetus less than 37 weeks of gestation&#xD;
&#xD;
          2. women diagnosed to having Threatened preterm labor.&#xD;
&#xD;
               1. presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )&#xD;
&#xD;
               2. cervical effacement &lt;80 %&#xD;
&#xD;
               3. cervical dilatation &lt;1 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. suspected fetal growth restriction,&#xD;
&#xD;
          2. maternal medical complications,&#xD;
&#xD;
          3. presence of fetal heart rate abnormalities at enrollment.&#xD;
&#xD;
          4. Preterm Premature rupture of membranes&#xD;
&#xD;
          5. Placenta previa&#xD;
&#xD;
          6. Lower urinary tract infection or genital infection&#xD;
&#xD;
          7. Fetal congenital anomaly&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</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>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03251794
org study id: FAGE
nct id: NCT03251794
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Preterm birth continues to be a major public health problem with lasting family and societal
      repercussions. Despite tremendous research effort, prevention strategies have failed, and the
      prevalence of preterm birth in the United States reached 12.3% in 2003.

      Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks'
      gestation. The rate of prematurity increases dramatically with the number of fetuses -
      singletons 10%; twins 54.9%; and triplets 93.6%
observational model: Cohort
time perspective: Prospective
measure: the volume of adrenal gland
time frame: 5 minutes
description: measurement by three dimensional ultrasound
arm group label: threatened preterm labor
description: women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix
intervention type: Diagnostic Test
intervention name: three dimensional ultrasound
description: evaluation of the suprarenal glands
arm group label: threatened preterm labor
intervention type: Diagnostic Test
intervention name: color Doppler
description: Doppler evaluation of the suprarenal artery
arm group label: threatened preterm labor
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: principal investigator
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
sharing ipd: Undecided