<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/NCT03292939</url>
  </required_header>
  <id_info>
    <org_study_id>7880</org_study_id>
    <nct_id>NCT03292939</nct_id>
  </id_info>
  <brief_title>Progestrone and Doppler Indices</brief_title>
  <official_title>The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal&#xD;
      doppler indices&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an&#xD;
      independent investigator blinded to the treatment, before and 48 hours after the ﬁrst&#xD;
      administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria)&#xD;
      ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color&#xD;
      imaging capabilities, was used in all cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of ultrasound doppler indices.</measure>
    <time_frame>before and 48 hours after progestrone admistration</time_frame>
    <description>A complete Doppler ﬂow assessment of the maternaland fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the ﬁrst administration of progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasoundmachine,equippedwitha3.5-MHzcurvilinearabdominaltransducer with color imaging capabilities, was used in all cases.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Preterm Labor</condition>
  <arm_group>
    <arm_group_label>vaginal progestrone group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>cohort of patients who received 400mg vaginal progestrone .</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>A complete Doppler ﬂow assessment of the maternal and fetal circulation</intervention_name>
    <description>A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, 48 hours after receiving 400mg of vaginal progestrone .Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine ,equipped with a 3.5-MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.</description>
    <arm_group_label>vaginal progestrone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age: 18-33 weeks&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
          -  History of preterm labor (&lt;34 weeks)&#xD;
&#xD;
          -  At risk for preterm labor ( increased amniotic fluid volume)&#xD;
&#xD;
          -  Short cervical length (&lt;25mm) as incidental finding&#xD;
&#xD;
          -  Presenting with actual cervical changes ( dilatation and\or effacement) in current&#xD;
             pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PPROM&#xD;
&#xD;
          -  Contraindication to progesterone use&#xD;
&#xD;
          -  Diabetic patients, have glucose intolerance&#xD;
&#xD;
          -  Multiple pregnancies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr El Ainiy Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>sarah mohamed hassan</investigator_full_name>
    <investigator_title>lecturer of obstetrics and gynecology Cairo university</investigator_title>
  </responsible_party>
  <keyword>progestrone</keyword>
  <keyword>doppler indices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor, Premature</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/NCT03292939
org study id: 7880
nct id: NCT03292939
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal
      doppler indices
A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an
      independent investigator blinded to the treatment, before and 48 hours after the ﬁrst
      administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria)
      ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color
      imaging capabilities, was used in all cases.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: change of ultrasound doppler indices.
time frame: before and 48 hours after progestrone admistration
description: A complete Doppler ﬂow assessment of the maternaland fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the ﬁrst administration of progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasoundmachine,equippedwitha3.5-MHzcurvilinearabdominaltransducer with color imaging capabilities, was used in all cases.
arm group label: vaginal progestrone group
arm group type: Other
description: cohort of patients who received 400mg vaginal progestrone .
intervention type: Diagnostic Test
intervention name: A complete Doppler ﬂow assessment of the maternal and fetal circulation
description: A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, 48 hours after receiving 400mg of vaginal progestrone .Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine ,equipped with a 3.5-MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.
arm group label: vaginal progestrone group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: sarah mohamed hassan
investigator title: lecturer of obstetrics and gynecology Cairo university
mesh term: Obstetric Labor, Premature
sharing ipd: No