<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/NCT03815344</url>
  </required_header>
  <id_info>
    <org_study_id>2017-03-09</org_study_id>
    <nct_id>NCT03815344</nct_id>
  </id_info>
  <brief_title>Combined Vaginal Misoprostol and Perivascular Vasopressin</brief_title>
  <official_title>A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maimonides Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maimonides Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood&#xD;
      vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and&#xD;
      thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at&#xD;
      as an additional method to decrease operative blood loss given its ability to increase&#xD;
      uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough&#xD;
      to warrant treatment in 20-50% of reproductive age women, including abnormal uterine&#xD;
      bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is&#xD;
      standard of care for symptomatic uterine fibroids, women desiring future child bearing&#xD;
      require removal of the fibroids alone via uterine myomectomy, with re-construction of the&#xD;
      uterus after removal. A well established risk to such a procedure is the operative blood&#xD;
      loss, which can be quite significant due to the increased blood supply fibroids accumulate.&#xD;
      Several interventions have been looked at as potential methods to help decrease operative&#xD;
      blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts&#xD;
      blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and&#xD;
      thereby resulting in less bleeding with removal. A known potential side effect of vasopressin&#xD;
      is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently&#xD;
      injected into the large vessels of the uterus. This limits the amount that can be safely used&#xD;
      in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease&#xD;
      operative blood loss given its ability to increase uterine muscle tone, which therefore&#xD;
      constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used&#xD;
      during surgery, the associated potential risks limit the amount that can be safely&#xD;
      administered. However, the addition Misoprostol, with a relatively safe side effect profile,&#xD;
      can further improve control of the blood supply and decrease operative blood loss.&#xD;
      Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories.&#xD;
      While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or&#xD;
      sublingual routes, the effect is maintained for a longer period of time, and is more&#xD;
      conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged&#xD;
      operative time associated with minimally invasive techniques when compared to traditional&#xD;
      open approaches. This study aims to determine whether using vaginal Misoprostol in&#xD;
      combination with Vasopressin is more effective at decreasing operative blood loss during&#xD;
      robotic assisted laparoscopic myomectomy than Vasopressin alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 26, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative Blood Loss</measure>
    <time_frame>0 hours up to 24 hours</time_frame>
    <description>The amount of blood loss during robotic assisted laparoscopic myomectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Operative Time</measure>
    <time_frame>0 hours up to 24 hours</time_frame>
    <description>Total time of the robotic assisted laparoscopic myomectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>0 hours up to 24 hours</time_frame>
    <description>Side Effect profile for Misoprostol Use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Leiomyoma</condition>
  <condition>Laparoscopy</condition>
  <condition>Uterine Myomectomy</condition>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-Vaginal Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard</intervention_name>
    <description>20 units diluted in 100mL of Normal Saline injected laparoscopic needle</description>
    <arm_group_label>Standard-Vaginal Misoprostol</arm_group_label>
    <other_name>Perivascular vasopresssin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard-vaginal misoprostol</intervention_name>
    <description>20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg</description>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_label>Standard-Vaginal Misoprostol</arm_group_label>
    <other_name>perivascular vasopresssin-vaginal misprostol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted&#xD;
             laparoscopic myomectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of adverse reaction or allergy to Vasopressin.&#xD;
&#xD;
          2. History of adverse reaction or allergy to Misoprostol.&#xD;
&#xD;
          3. Medical contraindication to use of Vasopressin or Misoprostol&#xD;
&#xD;
          4. Suspicion of possible reproductive cancer with contraindication of morcellation of&#xD;
             uterine tissue.&#xD;
&#xD;
          5. Significant medical condition or laboratory result that in the opinion of the&#xD;
             Investigator indicate an increased vulnerability to study subject which exposes the&#xD;
             subject to an unreasonable risk as a result of participating.&#xD;
&#xD;
          6. Any clinically significant even or condition uncovered during the surgery, such as&#xD;
             excessive bleeding or decompensation, that might render the subject medically unstable&#xD;
             to continue the study or complicate the subject's intraoperative or postoperative&#xD;
             course.&#xD;
&#xD;
          7. Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedram Bral, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maimonides Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary Ann H Son, M.D.</last_name>
    <phone>718 741 7100</phone>
    <email>sonmaryann@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pedram Bral, M.D.</last_name>
    <phone>718 741 7100</phone>
    <email>pbral@maimonidesmed.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Ann H Son, M.D.</last_name>
      <phone>718-741-7100</phone>
      <email>sonmaryann@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sara Meeder</last_name>
      <phone>718 283 7253</phone>
      <email>smeeder@maimonidesmed.org</email>
    </contact_backup>
    <investigator>
      <last_name>Lily N Shamsnia, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mary Ann H Son, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pedram Bral, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.fda.gov/Drugs/DrugSafety/default.htm</url>
    <description>FDA website</description>
  </link>
  <results_reference>
    <citation>Iavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4.</citation>
    <PMID>26041328</PMID>
  </results_reference>
  <results_reference>
    <citation>Kalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9.</citation>
    <PMID>21485725</PMID>
  </results_reference>
  <results_reference>
    <citation>Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.</citation>
    <PMID>7026295</PMID>
  </results_reference>
  <results_reference>
    <citation>Cohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30.</citation>
    <PMID>27362908</PMID>
  </results_reference>
  <results_reference>
    <citation>Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.</citation>
    <PMID>25125317</PMID>
  </results_reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>May 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>December 10, 2019</last_update_submitted>
  <last_update_submitted_qc>December 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maimonides Medical Center</investigator_affiliation>
    <investigator_full_name>Pedram Bral</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Robot-assisted</keyword>
  <keyword>Laparoscopic</keyword>
  <keyword>vasopressin</keyword>
  <keyword>misoprostol</keyword>
  <keyword>blood loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>December 11, 2019</submitted>
    <returned>December 26, 2019</returned>
  </pending_results>
  <!-- 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/NCT03815344
org study id: 2017-03-09
nct id: NCT03815344
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood
      vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and
      thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at
      as an additional method to decrease operative blood loss given its ability to increase
      uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough
      to warrant treatment in 20-50% of reproductive age women, including abnormal uterine
      bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is
      standard of care for symptomatic uterine fibroids, women desiring future child bearing
      require removal of the fibroids alone via uterine myomectomy, with re-construction of the
      uterus after removal. A well established risk to such a procedure is the operative blood
      loss, which can be quite significant due to the increased blood supply fibroids accumulate.
      Several interventions have been looked at as potential methods to help decrease operative
      blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts
      blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and
      thereby resulting in less bleeding with removal. A known potential side effect of vasopressin
      is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently
      injected into the large vessels of the uterus. This limits the amount that can be safely used
      in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease
      operative blood loss given its ability to increase uterine muscle tone, which therefore
      constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used
      during surgery, the associated potential risks limit the amount that can be safely
      administered. However, the addition Misoprostol, with a relatively safe side effect profile,
      can further improve control of the blood supply and decrease operative blood loss.
      Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories.
      While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or
      sublingual routes, the effect is maintained for a longer period of time, and is more
      conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged
      operative time associated with minimally invasive techniques when compared to traditional
      open approaches. This study aims to determine whether using vaginal Misoprostol in
      combination with Vasopressin is more effective at decreasing operative blood loss during
      robotic assisted laparoscopic myomectomy than Vasopressin alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Operative Blood Loss
time frame: 0 hours up to 24 hours
description: The amount of blood loss during robotic assisted laparoscopic myomectomy
measure: Total Operative Time
time frame: 0 hours up to 24 hours
description: Total time of the robotic assisted laparoscopic myomectomy
measure: Side Effects
time frame: 0 hours up to 24 hours
description: Side Effect profile for Misoprostol Use
arm group label: Standard
arm group type: Active Comparator
description: Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.
arm group label: Standard-Vaginal Misoprostol
arm group type: Experimental
description: Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .
intervention type: Drug
intervention name: Standard
description: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle
arm group label: Standard-Vaginal Misoprostol
other name: Perivascular vasopresssin
intervention type: Drug
intervention name: Standard-vaginal misoprostol
description: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
arm group label: Standard
arm group label: Standard-Vaginal Misoprostol
other name: perivascular vasopresssin-vaginal misprostol
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pedram Bral, M.D.
role: Principal Investigator
affiliation: Maimonides Medical Center
last name: Mary Ann H Son, M.D.
phone: 718 741 7100
email: sonmaryann@gmail.com
last name: Pedram Bral, M.D.
phone: 718 741 7100
email: pbral@maimonidesmed.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
url: https://www.fda.gov/Drugs/DrugSafety/default.htm
description: FDA website
citation: Iavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4.
PMID: 26041328
citation: Kalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9.
PMID: 21485725
citation: Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.
PMID: 7026295
citation: Cohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30.
PMID: 27362908
citation: Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
PMID: 25125317
responsible party type: Principal Investigator
investigator affiliation: Maimonides Medical Center
investigator full name: Pedram Bral
investigator title: Principal Investigator
mesh term: Leiomyoma
mesh term: Misoprostol
sharing ipd: No
ipd description: IPD will not be shared.
submitted: December 11, 2019
returned: December 26, 2019