<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/NCT02245191</url>
  </required_header>
  <id_info>
    <org_study_id>VASPRES-3</org_study_id>
    <nct_id>NCT02245191</nct_id>
  </id_info>
  <brief_title>Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation</brief_title>
  <official_title>Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation in Patients With Preeclampsia Under Spinal Anesthesia for Cesarean</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>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a prospective clinical trial with random distribution that intends to investigate&#xD;
      maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean&#xD;
      delivery in patients with pre-eclampsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to&#xD;
      avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and&#xD;
      promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable&#xD;
      for mother and child when referring to the side effects, including hypotension. The choice of&#xD;
      the best vasopressor in this context is approaching to a resolution, favoring phenylephrine&#xD;
      use. However, studies on high-risk pregnancies are still required, such as uteroplacental&#xD;
      insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this&#xD;
      study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol&#xD;
      on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with&#xD;
      preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be&#xD;
      recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol,&#xD;
      making a total of three groups with 20 patients each. Variables to be analyzed are uterine&#xD;
      arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral&#xD;
      artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean&#xD;
      arterial blood pressure and maternal peripheral vascular resistance. These variables will be&#xD;
      recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent&#xD;
      and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after&#xD;
      vasopressor bolus. Averages will be calculated in these intervals and then compared to the&#xD;
      alteration caused by spinal anesthesia and the return to basal levels after drug&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.</measure>
    <time_frame>One year</time_frame>
    <description>The main purpose of this study is evaluate if one of related drugs (ephedrine, phenylephrine or metaraminol) is superior than others to keep the maternal cardiac output, uteroplacental and fetal cerebral bloodflow despite the hemodynamic changes that is peculiar after spinal anesthesia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Ephedrine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will receive ephedrine after spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phenylephrine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will receive Phenylephrine after spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metaraminol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will receive Metaraminol after spinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ephedrine</intervention_name>
    <description>5mg after Spinal Anesthesia</description>
    <arm_group_label>Ephedrine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>100mcg after Spinal Anesthesia</description>
    <arm_group_label>Phenylephrine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metaraminol</intervention_name>
    <description>200mcg Metaraminol after Spinal Anesthesia</description>
    <arm_group_label>Metaraminol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preeclampsia patients&#xD;
&#xD;
          -  After 34 weeks pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients' refusal&#xD;
&#xD;
          -  Obstetric Emergency&#xD;
&#xD;
          -  Contraindications to spinal anesthesia&#xD;
&#xD;
          -  Obesity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Bliacheriene, MD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto do Coracao</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vasopressor</keyword>
  <keyword>Cesarian delivery</keyword>
  <keyword>Hypotension</keyword>
  <keyword>Maternal cardiac output</keyword>
  <keyword>Uteroplacental blood flow</keyword>
  <keyword>Cerebral fetal blood flow</keyword>
  <keyword>Preeclampsia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Ephedrine</mesh_term>
    <mesh_term>Metaraminol</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/NCT02245191
org study id: VASPRES-3
nct id: NCT02245191
lead sponsor: 
has dmc: Yes
It is a prospective clinical trial with random distribution that intends to investigate
      maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean
      delivery in patients with pre-eclampsia.
Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to
      avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and
      promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable
      for mother and child when referring to the side effects, including hypotension. The choice of
      the best vasopressor in this context is approaching to a resolution, favoring phenylephrine
      use. However, studies on high-risk pregnancies are still required, such as uteroplacental
      insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this
      study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol
      on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with
      preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be
      recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol,
      making a total of three groups with 20 patients each. Variables to be analyzed are uterine
      arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral
      artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean
      arterial blood pressure and maternal peripheral vascular resistance. These variables will be
      recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent
      and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after
      vasopressor bolus. Averages will be calculated in these intervals and then compared to the
      alteration caused by spinal anesthesia and the return to basal levels after drug
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.
time frame: One year
description: The main purpose of this study is evaluate if one of related drugs (ephedrine, phenylephrine or metaraminol) is superior than others to keep the maternal cardiac output, uteroplacental and fetal cerebral bloodflow despite the hemodynamic changes that is peculiar after spinal anesthesia.
measure: Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia
time frame: One year
measure: Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.
time frame: One year
measure: Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use
time frame: One year
arm group label: Ephedrine Group
arm group type: Experimental
description: Patients who will receive ephedrine after spinal anesthesia
arm group label: Phenylephrine Group
arm group type: Experimental
description: Patients who will receive Phenylephrine after spinal anesthesia
arm group label: Metaraminol
arm group type: Experimental
description: Patients who will receive Metaraminol after spinal anesthesia
intervention type: Drug
intervention name: Ephedrine
description: 5mg after Spinal Anesthesia
arm group label: Ephedrine Group
intervention type: Drug
intervention name: Phenylephrine
description: 100mcg after Spinal Anesthesia
arm group label: Phenylephrine Group
intervention type: Drug
intervention name: Metaraminol
description: 200mcg Metaraminol after Spinal Anesthesia
arm group label: Metaraminol
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fernando Bliacheriene, MD
role: Study Director
affiliation: Instituto do Coracao
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Ephedrine
mesh term: Metaraminol