xml: <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/NCT05986266</url>
    </required_header>
    <id_info>
      <org_study_id>Micheal Hany Monir</org_study_id>
      <nct_id>NCT05986266</nct_id>
    </id_info>
    <brief_title>Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss</brief_title>
    <official_title>Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Egymedicalpedia</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Egymedicalpedia</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from&#xD;
        myometrial cells of the uterine smooth muscle tissue. Although most are asymptomatic,&#xD;
        fibroids can often cause abnormal uterine bleeding, iron deficiency anemia, pelvic pressure&#xD;
        symptoms and pain&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Women with myomatous uteri have an increased number of blood supply which may cause excessive&#xD;
        bleeding during myomectomy. The excessive bleeding may result in blood transfusions and&#xD;
        prolonged hospital stays. A variety of methods are used to reduce bleeding during myomectomy&#xD;
        including preoperative administration of gonadotropin-releasing hormone (GnRH) agonists,&#xD;
        uterine artery tourniquet, vaginal misoprostol, intravenous tranexamic acid, intramyometrial&#xD;
        injections of bupivacaine plus adrenaline and vasopressin, chemical dissection with Mesna&#xD;
        (sodium-2-mercaptoethanesulfonate), perioperative injection of ascorbic acid, and, recently,&#xD;
        carbetocin.&#xD;
  &#xD;
        Currently, there are several strategies for the treatment of fibroids. Still, myomectomy, the&#xD;
        surgical removal of myomas, is an important treatment option for symptomatic leiomyomas,&#xD;
        especially in women who wish to preserve their uteri.This can be accomplished via laparotomy,&#xD;
        laparoscopy or hysteroscopy.&#xD;
  &#xD;
        Oxytocin is a hormone secreted from the posterior pituitary and exerts its effect on the&#xD;
        uterus by producing uterine contractions during labor and delivery. Because of this&#xD;
        contractile feature, synthetic oxytocin analogs are used in the treatment of postpartum&#xD;
        uterine atony and hemorrhage. Based on its ability to attenuate blood loss, oxytocin has been&#xD;
        evaluated in gynecologic procedures, including hysterectomies, myomectomies, and endometrial&#xD;
        resections. Although the expression of oxytocin receptors is thought to be strictly related&#xD;
        to pregnancy, their presence has been demonstrated in the leiomyomatous uterus.&#xD;
  &#xD;
        Carbetocin was first introduced to control postpartum hemorrhage, but its manageability and&#xD;
        efficacy soon made it an interesting option for gynecologic surgeons. Given its longer&#xD;
        half-life compared with oxytocin and its ample bioavailability, carbetocin could represent a&#xD;
        very useful tool during myomectomy, administered either intravenously or intramuscularly&#xD;
        Following promising reports on the effectiveness of carbetocin in reducing intraoperative&#xD;
        blood loss, hemoglobin drop, and need for postoperative blood transfusions.&#xD;
  &#xD;
        Adrenaline is a potent vasoconstrictive agent that has a high risk of cardiovascular effects&#xD;
        if an intravascular instillation is performed. The vasoconstrictive effect of adrenaline on&#xD;
        tissue lasts longer than that of vasopressin.&#xD;
  &#xD;
        Bupivacaine is a local anesthetic that causes vasodilatation at clinical doses, but lower&#xD;
        doses appear to cause vasoconstriction. Bupivacaine has shown to have a vasoconstrictive&#xD;
        activity in concentrations of ≤ 0.25%, with duration of its action between 4 and 24 h when&#xD;
        used for local infiltration. The use of a combination of bupivacaine and low dose of&#xD;
        adrenaline in order to minimize the cardiovascular effects of the latest without interfering&#xD;
        with the vasoconstrictive effects on haemostasis has been documented.&#xD;
  &#xD;
        The myometrial injection of adrenaline plus bupivacaine was one of the evaluated methods&#xD;
        showing significantly reduced blood loss and shorter duration of surgery compared to placebo&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
    <phase>Phase 1</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)</measure>
      <time_frame>First 2 hours after abdominal myomectomy</time_frame>
      <description>Compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in reducing intraoperative blood loss during abdominal myomectomy Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Side Effects Of the used drugs in the operation</measure>
      <time_frame>First 24 hours after abdominal myomectomy</time_frame>
      <description>Need for blood transfusion.&#xD;
  Duration of surgery.&#xD;
  Operative complications.&#xD;
  Post operative adverse effects such as allergy, cardiovascular disorders and pulmonary edema, etc.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">62</enrollment>
    <condition>Uterine Fibroid</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients will receive carbetocin, The optimal carbetocin dose(IV or IM) is 100 mcg. The carbetocin group will receive 100 mcg IV carbetocin (Pabal; Ferring Pharmaceuticals) in 10 mL saline solution. The anesthesiologists will administrate carbetocin slowly over 5 minutes (at a rate of 2 mL/min) to maintain hemodynamic stability.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will receive adrenalin, infiltration of the serosa and/or myometrium overlying the leiomyoma before uterine incision with a solution composed of 50 ml Bupivacaine HCL 0.25% and 0.5 mg of adrenaline.The anesthesiologist will be informed prior to the injection of the solution to ensure proper monitoring. The solution will be prepared just before the procedure. Before each infiltration, aspiration will be performed to avoid intravascular injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carbetocin</intervention_name>
      <description>To compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in decreasing intraoperative blood loss and need for blood transfusion during abdominal myomectomy.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
      <other_name>Adrenaline</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 25-50 years old.&#xD;
  &#xD;
            -  Women who will undergo abdominal myomectomy because of symptomatic stage 3-6 fibroids,&#xD;
               according to FIGO staging (Laughlin-Tommaso et al., 2017), with the number of myomas&#xD;
               not exceeding five based on the preoperative ultrasonography (US).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women with previous myomectomy.&#xD;
  &#xD;
            -  Pregnant and postmenopausal women.&#xD;
  &#xD;
            -  Women with preoperative hemoglobin concentration &lt;10 g/dL,&#xD;
  &#xD;
            -  women who are candidate for and choosing vaginal or laparoscopic myomectomy.&#xD;
  &#xD;
            -  History of preoperative embolization or hormone therapy (GnRH analogues), cervical and&#xD;
               broad ligament myoma, number of myomas more than five on preoperative US, myoma FIGO&#xD;
               stages 1,2,7 and 8 (Munro et al., 2011)&#xD;
  &#xD;
            -  Patients with allergy or contraindications to carbetocin or epinephrine, such as&#xD;
               coronary artery disease, asthma, epilepsy, migraine, kidney, and hepatic disease.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Months</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Waleed Saber, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Micheal Hany Monir, MSC</last_name>
      <phone>01279266613</phone>
      <email>Michealhany@icloud.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of medicine, Cairo University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Khaled Kholaif, Lecturer</last_name>
        <phone>01003308113</phone>
        <email>khaledkholaif@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Sherif Sameh Zaki, Assist.Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Carbetocin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986266
  org study id: Micheal Hany Monir
  nct id: NCT05986266
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from
        myometrial cells of the uterine smooth muscle tissue. Although most are asymptomatic,
        fibroids can often cause abnormal uterine bleeding, iron deficiency anemia, pelvic pressure
        symptoms and pain
  Women with myomatous uteri have an increased number of blood supply which may cause excessive
        bleeding during myomectomy. The excessive bleeding may result in blood transfusions and
        prolonged hospital stays. A variety of methods are used to reduce bleeding during myomectomy
        including preoperative administration of gonadotropin-releasing hormone (GnRH) agonists,
        uterine artery tourniquet, vaginal misoprostol, intravenous tranexamic acid, intramyometrial
        injections of bupivacaine plus adrenaline and vasopressin, chemical dissection with Mesna
        (sodium-2-mercaptoethanesulfonate), perioperative injection of ascorbic acid, and, recently,
        carbetocin.
  
        Currently, there are several strategies for the treatment of fibroids. Still, myomectomy, the
        surgical removal of myomas, is an important treatment option for symptomatic leiomyomas,
        especially in women who wish to preserve their uteri.This can be accomplished via laparotomy,
        laparoscopy or hysteroscopy.
  
        Oxytocin is a hormone secreted from the posterior pituitary and exerts its effect on the
        uterus by producing uterine contractions during labor and delivery. Because of this
        contractile feature, synthetic oxytocin analogs are used in the treatment of postpartum
        uterine atony and hemorrhage. Based on its ability to attenuate blood loss, oxytocin has been
        evaluated in gynecologic procedures, including hysterectomies, myomectomies, and endometrial
        resections. Although the expression of oxytocin receptors is thought to be strictly related
        to pregnancy, their presence has been demonstrated in the leiomyomatous uterus.
  
        Carbetocin was first introduced to control postpartum hemorrhage, but its manageability and
        efficacy soon made it an interesting option for gynecologic surgeons. Given its longer
        half-life compared with oxytocin and its ample bioavailability, carbetocin could represent a
        very useful tool during myomectomy, administered either intravenously or intramuscularly
        Following promising reports on the effectiveness of carbetocin in reducing intraoperative
        blood loss, hemoglobin drop, and need for postoperative blood transfusions.
  
        Adrenaline is a potent vasoconstrictive agent that has a high risk of cardiovascular effects
        if an intravascular instillation is performed. The vasoconstrictive effect of adrenaline on
        tissue lasts longer than that of vasopressin.
  
        Bupivacaine is a local anesthetic that causes vasodilatation at clinical doses, but lower
        doses appear to cause vasoconstriction. Bupivacaine has shown to have a vasoconstrictive
        activity in concentrations of ≤ 0.25%, with duration of its action between 4 and 24 h when
        used for local infiltration. The use of a combination of bupivacaine and low dose of
        adrenaline in order to minimize the cardiovascular effects of the latest without interfering
        with the vasoconstrictive effects on haemostasis has been documented.
  
        The myometrial injection of adrenaline plus bupivacaine was one of the evaluated methods
        showing significantly reduced blood loss and shorter duration of surgery compared to placebo
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
  time frame: First 2 hours after abdominal myomectomy
  description: Compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in reducing intraoperative blood loss during abdominal myomectomy Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.
  measure: Side Effects Of the used drugs in the operation
  time frame: First 24 hours after abdominal myomectomy
  description: Need for blood transfusion.
  Duration of surgery.
  Operative complications.
  Post operative adverse effects such as allergy, cardiovascular disorders and pulmonary edema, etc.
  arm group label: Group A
  arm group type: Active Comparator
  description: patients will receive carbetocin, The optimal carbetocin dose(IV or IM) is 100 mcg. The carbetocin group will receive 100 mcg IV carbetocin (Pabal; Ferring Pharmaceuticals) in 10 mL saline solution. The anesthesiologists will administrate carbetocin slowly over 5 minutes (at a rate of 2 mL/min) to maintain hemodynamic stability.
  arm group label: Group B
  arm group type: Experimental
  description: patients will receive adrenalin, infiltration of the serosa and/or myometrium overlying the leiomyoma before uterine incision with a solution composed of 50 ml Bupivacaine HCL 0.25% and 0.5 mg of adrenaline.The anesthesiologist will be informed prior to the injection of the solution to ensure proper monitoring. The solution will be prepared just before the procedure. Before each infiltration, aspiration will be performed to avoid intravascular injection
  intervention type: Drug
  intervention name: Carbetocin
  description: To compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in decreasing intraoperative blood loss and need for blood transfusion during abdominal myomectomy.
  arm group label: Group A
  arm group label: Group B
  other name: Adrenaline
  criteria: 
  gender: Female
  minimum age: 25 Months
  maximum age: 50 Years
  healthy volunteers: No
  last name: Waleed Saber, Professor
  role: Study Chair
  affiliation: Cairo University
  last name: Micheal Hany Monir, MSC
  phone: 01279266613
  email: Michealhany@icloud.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Leiomyoma
  mesh term: Carbetocin
  sharing ipd: Undecided