<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/NCT02973230</url>
  </required_header>
  <id_info>
    <org_study_id>fcabarVEGF1</org_study_id>
    <nct_id>NCT02973230</nct_id>
  </id_info>
  <brief_title>Serum VEGF as a Tubal Pregnancy Marker</brief_title>
  <official_title>Serum Vascular Endothelial Growth Factor (VEGF) As a Marker for Tubal Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <brief_summary>
    <textblock>
      The aim of the present study was (i) to evaluate whether a single measurement of VEGF would&#xD;
      allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii)&#xD;
      to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each subgroup.&#xD;
&#xD;
      Ninety patients were selected from a population of women presenting to the Hospital das&#xD;
      Clínicas of the University of São Paulo Medical School from October 2006 until September 2007&#xD;
      and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy (defined&#xD;
      as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a embryo&#xD;
      greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence of&#xD;
      intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels in 48&#xD;
      hours); all tubal pregnancies were surgically treated and were histologically confirmed, they&#xD;
      did not receive any methotrexate treatment before operation; (iii) normal intrauterine&#xD;
      pregnancy (intrauterine gestational sac, embryo vitality confirmed).&#xD;
&#xD;
      Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of&#xD;
      blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations).&#xD;
      Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at&#xD;
      room temperature for 2-6 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <completion_date type="Actual">September 2007</completion_date>
  <primary_completion_date type="Actual">September 2007</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>VEGF serum concentration</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Pregnancy, Ectopic</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dosage of VEGF serum concentration</intervention_name>
    <description>Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at room temperature for 2-6 hours.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria were:&#xD;
&#xD;
          -  women that had a positive hCG test and presented with either abdominal pain or vaginal&#xD;
             bleeding; all pregnancies were singletons, spontaneously conceived, with accurate&#xD;
             assessments of their gestational age (42 - 56 days from the first day of the last&#xD;
             menstrual period). A detailed informed consent was obtained from each patient before&#xD;
             the inclusion.&#xD;
&#xD;
        Exclusion Criteria was:&#xD;
&#xD;
          -  non-ampullar tubal pregnancy (surgically confirmed).&#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>University of Sao Paulo - School of Medicine - General Hospital</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Fábio Roberto Cabar</investigator_full_name>
    <investigator_title>MD; MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>Pregnancy, Ectopic</keyword>
  <keyword>Vascular Endothelial Growth Factor A</keyword>
  <keyword>Pregnancy, Tubal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Tubal</mesh_term>
    <mesh_term>Pregnancy, Ectopic</mesh_term>
    <mesh_term>Cardiac Complexes, Premature</mesh_term>
  </condition_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/NCT02973230
org study id: fcabarVEGF1
nct id: NCT02973230
lead sponsor: 
The aim of the present study was (i) to evaluate whether a single measurement of VEGF would
      allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii)
      to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each subgroup.

      Ninety patients were selected from a population of women presenting to the Hospital das
      Clínicas of the University of São Paulo Medical School from October 2006 until September 2007
      and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy (defined
      as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a embryo
      greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence of
      intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels in 48
      hours); all tubal pregnancies were surgically treated and were histologically confirmed, they
      did not receive any methotrexate treatment before operation; (iii) normal intrauterine
      pregnancy (intrauterine gestational sac, embryo vitality confirmed).

      Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of
      blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations).
      Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at
      room temperature for 2-6 hours.
measure: VEGF serum concentration
time frame: One year
intervention type: Other
intervention name: Dosage of VEGF serum concentration
description: Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at room temperature for 2-6 hours.
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Fábio Roberto Cabar
investigator title: MD; MSc, PhD
mesh term: Pregnancy, Tubal
mesh term: Pregnancy, Ectopic
mesh term: Cardiac Complexes, Premature