<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/NCT01700478</url>
  </required_header>
  <id_info>
    <org_study_id>MV-001</org_study_id>
    <nct_id>NCT01700478</nct_id>
  </id_info>
  <brief_title>Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy</brief_title>
  <official_title>A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of the West Indies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of the West Indies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was done to determine if the use of a combination of preoperative rectal&#xD;
      misoprostol 400µg used with intraoperative perivascular vasopressin is better than&#xD;
      perivascular vasopressin used alone to decrease bleeding at myomectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus.&#xD;
      This procedure can be associated with significant blood loss which can result in significant&#xD;
      morbidity and mortality. The drug misoprostol which has been been use in the treatment of&#xD;
      postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective&#xD;
      myomectomy at the University hospital of the West Indies and from the private practice of the&#xD;
      participating doctors who were invited to participate in the study. Patients were randomized&#xD;
      to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before&#xD;
      surgery. Twenty five patients received misoprostol and twenty patients did not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2005</start_date>
  <completion_date type="Actual">April 2005</completion_date>
  <primary_completion_date type="Actual">April 2005</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood loss in millilitres</measure>
    <time_frame>At the time of surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>A change in hemoglobin grams per decilitre</measure>
    <time_frame>At baseline and 24hours after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Misoprostol + vasopressin, Vasopressin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Misoprostol 400ug given rectally one hour before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol + vasopressin</intervention_name>
    <description>400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.</description>
    <arm_group_label>Misoprostol + vasopressin, Vasopressin</arm_group_label>
    <other_name>Cytotec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressin</intervention_name>
    <description>Vasopressin was used in all patients during surgery.</description>
    <arm_group_label>Misoprostol + vasopressin, Vasopressin</arm_group_label>
    <other_name>Anti-diuretic hormone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with symptomatic fibroids who desire future fertility and or who wish to&#xD;
             maintain their uterus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have had previous myomectomy or previous pelvic surgery.&#xD;
&#xD;
          -  patients who are severely anemic or who have significant medical conditions such as&#xD;
             cardiac or pulmonary disease.&#xD;
&#xD;
          -  patients who refuse to participate or give consent to the procedures. Patients with a&#xD;
             known allergy to any of the study drugs.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharifa K Frederick, dM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of the West Indies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of the West Indies</name>
      <address>
        <city>Kingston</city>
        <country>Jamaica</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jamaica</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>February 7, 2013</last_update_submitted>
  <last_update_submitted_qc>February 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of the West Indies</investigator_affiliation>
    <investigator_full_name>Dr Sharifa Frederick</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Myomectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Diuretics</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/NCT01700478
org study id: MV-001
nct id: NCT01700478
lead sponsor: 
has dmc: No
This study was done to determine if the use of a combination of preoperative rectal
      misoprostol 400µg used with intraoperative perivascular vasopressin is better than
      perivascular vasopressin used alone to decrease bleeding at myomectomy.
A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus.
      This procedure can be associated with significant blood loss which can result in significant
      morbidity and mortality. The drug misoprostol which has been been use in the treatment of
      postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective
      myomectomy at the University hospital of the West Indies and from the private practice of the
      participating doctors who were invited to participate in the study. Patients were randomized
      to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before
      surgery. Twenty five patients received misoprostol and twenty patients did not.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Blood loss in millilitres
time frame: At the time of surgery
measure: A change in hemoglobin grams per decilitre
time frame: At baseline and 24hours after surgery
arm group label: Misoprostol + vasopressin, Vasopressin
arm group type: Experimental
description: Misoprostol 400ug given rectally one hour before surgery.
intervention type: Drug
intervention name: Misoprostol + vasopressin
description: 400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
arm group label: Misoprostol + vasopressin, Vasopressin
other name: Cytotec
intervention type: Drug
intervention name: Vasopressin
description: Vasopressin was used in all patients during surgery.
arm group label: Misoprostol + vasopressin, Vasopressin
other name: Anti-diuretic hormone
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharifa K Frederick, dM
role: Principal Investigator
affiliation: University Hospital of the West Indies
facility: 
country: Jamaica
responsible party type: Principal Investigator
investigator affiliation: University Hospital of the West Indies
investigator full name: Dr Sharifa Frederick
investigator title: Doctor
mesh term: Hemorrhage
mesh term: Vasopressins
mesh term: Arginine Vasopressin
mesh term: Misoprostol
mesh term: Diuretics