<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/NCT02209545</url>
  </required_header>
  <id_info>
    <org_study_id>STU00091259</org_study_id>
    <nct_id>NCT02209545</nct_id>
  </id_info>
  <brief_title>Misoprostol for Reduction of Blood Loss During Fibroid Surgery</brief_title>
  <official_title>Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research work is to assess the impact of a single preoperative dose of buccal&#xD;
      misoprostol in reducing blood loss during abdominal fibroid surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care&#xD;
      center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under&#xD;
      the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity.&#xD;
      Intra-operative blood loss will be compared between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was prematurely closed due to low enrollment rates.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2022</completion_date>
  <primary_completion_date type="Actual">July 2022</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated Intra-operative Blood Loss</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Procedure</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Intra-operative time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Inpatient Hospitalization</measure>
    <time_frame>Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively</time_frame>
    <description>Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Blood Transfusion</measure>
    <time_frame>From time of surgery completion through discharge from hospital, an expected average period of 3 days</time_frame>
    <description>Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Fibroids</condition>
  <arm_group>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
    <arm_group_label>Misoprostol</arm_group_label>
    <other_name>Cytotec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Vitamin B6 (pyridoxine)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting for abdominal myomectomy with documented uterine fibroids on&#xD;
             pelvic imaging (pelvic ultrasound or MRI) within in last 12 months&#xD;
&#xD;
          -  Age ≥ 18 years and ≤ 50 years&#xD;
&#xD;
          -  Pre-operative hemoglobin &gt;8 g/dl&#xD;
&#xD;
          -  Willing to have buccal administration of misoprostol or a placebo at least one hour&#xD;
             pre-procedure.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          -  Admissible medical/surgical history&#xD;
&#xD;
          -  Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills&#xD;
&#xD;
          -  Intraoperative use of vasopressin and uterine tourniquet is permissible&#xD;
&#xD;
          -  Can have had prior Cesarean delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had a prior abdominal myomectomy&#xD;
&#xD;
          -  Post-menopausal women&#xD;
&#xD;
          -  Patients with known bleeding/clotting disorders&#xD;
&#xD;
          -  Patients with a history of gynecologic malignancy&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to misoprostol&#xD;
&#xD;
          -  Any cases converted to abdominal hysterectomy or other additional elective surgical&#xD;
             procedures performed at time of abdominal myomectomy will be excluded from data&#xD;
             analysis&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdy Milad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University, Northwestern Memorial Hopsital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University, Prentice Women's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>July 12, 2023</results_first_submitted>
  <results_first_submitted_qc>August 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2023</results_first_posted>
  <last_update_submitted>August 12, 2023</last_update_submitted>
  <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Magdy Milad, MD</investigator_full_name>
    <investigator_title>Professor in Obstetrics and Gynecology, Reproductive Endo &amp; Infertility</investigator_title>
  </responsible_party>
  <keyword>fibroids, leiomyomata, blood loss, misoprostol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyridoxine</mesh_term>
    <mesh_term>Vitamin B 6</mesh_term>
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT02209545/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT02209545/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Forty-seven patients enrolled in the study by signing the informed consent form. However, due to the premature closure, not all participants had the opportunity to undergo the intended intervention. Of these, 39 participants successfully completed the intervention, while 8 participants could not undergo the intervention as planned.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Misoprostol</title>
          <description>13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Misoprostol</title>
          <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Estimated Intra-operative Blood Loss</title>
        <description>Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.</description>
        <time_frame>Intra-operative</time_frame>
        <population>No data was collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Intra-operative Blood Loss</title>
          <description>Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.</description>
          <population>No data was collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Procedure</title>
        <description>Intra-operative time</description>
        <time_frame>Intra-operative</time_frame>
        <population>No data was collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Procedure</title>
          <description>Intra-operative time</description>
          <population>No data was collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Inpatient Hospitalization</title>
        <description>Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.</description>
        <time_frame>Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively</time_frame>
        <population>No data was collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Inpatient Hospitalization</title>
          <description>Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.</description>
          <population>No data was collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Blood Transfusion</title>
        <description>Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).</description>
        <time_frame>From time of surgery completion through discharge from hospital, an expected average period of 3 days</time_frame>
        <population>No data was collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Misoprostol</title>
            <description>13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Blood Transfusion</title>
          <description>Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).</description>
          <population>No data was collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored through study completion, an average of 7 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Misoprostol</title>
          <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.&#xD;
Misoprostol: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.&#xD;
Placebo: 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Magdy Milad</name_or_title>
      <organization>Northwestern Medicine</organization>
      <phone>3126946447</phone>
      <email>mmilad@nm.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02209545
org study id: STU00091259
nct id: NCT02209545
lead sponsor: 
has dmc: No
The aim of this research work is to assess the impact of a single preoperative dose of buccal
      misoprostol in reducing blood loss during abdominal fibroid surgery.
This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care
      center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under
      the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity.
      Intra-operative blood loss will be compared between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Estimated Intra-operative Blood Loss
time frame: Intra-operative
description: Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.
measure: Duration of Procedure
time frame: Intra-operative
description: Intra-operative time
measure: Length of Inpatient Hospitalization
time frame: Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively
description: Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.
measure: Post-operative Blood Transfusion
time frame: From time of surgery completion through discharge from hospital, an expected average period of 3 days
description: Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).
arm group label: Misoprostol
arm group type: Experimental
description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
arm group label: Placebo
arm group type: Placebo Comparator
description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
intervention type: Drug
intervention name: Misoprostol
description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
arm group label: Misoprostol
other name: Cytotec
intervention type: Drug
intervention name: Placebo
description: 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
arm group label: Placebo
other name: Vitamin B6 (pyridoxine)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Magdy Milad, MD
role: Principal Investigator
affiliation: Northwestern University, Northwestern Memorial Hopsital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Magdy Milad, MD
investigator title: Professor in Obstetrics and Gynecology, Reproductive Endo & Infertility
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Hemorrhage
mesh term: Pyridoxine
mesh term: Vitamin B 6
mesh term: Misoprostol
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 