<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20110530006640N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Intrauterine Instillation of Tranexamic Acid on Postoperative Hemoglobin in Hysteroscopic Myomectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53490</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, we will use the block randomization method that will be designed by the epidemiologist using STATA software, version 13. The number of blocks is considered to be 6. The random allocation list will be only available to the operation room nurse. To conceal the random allocation process, 70 treatment cards written in order, will be placed in sealed envelopes. When the surgeon determines the patient's eligibility, the nurse opens the envelope related to the type of intervention and determines the type of media that should be used for the patient according to the contents of the envelope and provides it to the surgeon's assistant, who has no role in conducting the research, Blinding description: Occasionally, normal saline is used at room temperature as a distending medium in this surgery, which will also be used in the control group. In the intervention group, 0.5 g of tranexamic acid ampoule per 1000 cc of distending medium will be dissolved and used. The surgeon is not aware of the presence of tranexamic acid in the distending medium and immediately after the surgery will record study variables without knowing the type of medium used; Therefore, the surgeon, the patient, and the outcome assessor (the surgeon) are not aware of the type of media and intervention. Also, for data analysis, a statistician who is separate from the study process and is unaware of all the processes will perform analyses. Also, a statistical expert who is not aware of the type of interventions will analyze the data.</study_design>
      <phase>3</phase>
      <hc_freetext>Submucous leiomyoma of uterus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, tranexamic acid ampoule with a dose of 0.5 g per 1000 cc of normal saline distending medium will be used (considering that the injection dose is 1 gram and can be repeated every 6 to 8 hours and can be used in electrolyte solutions according to the manufacturer's instructions). (Manufactured by Caspian Tamin Pharmaceutical). Intervention 2: Control group: In the control group, according to the routine, only normal saline will be used as distending medium.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No decision has been made yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Venus Chegini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Women 's Hospital, Rashid Ave, Resalat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7771 9922</telephone>
        <email>venus_chegini@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zahra Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Women 's Hospital, Rashid Ave, Resalat Highway,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>00219877719922</telephone>
        <email>asgariza@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with one submucosal myoma
Myoma should be completely in the endometrial cavity or extending less than 50% into the myometrium (type 0 and 1, based on FIGO's classification)
Myoma size less than 4 cm in the largest diameter confirmed by accurate transvaginal ultrasound
Candidates for hysteroscopy and myomectomy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pelvic infections
History of uterine or cervical cancer; Hematological, cardiovascular, thromboembolic, hepatic, and renal disorders; or Thromboembolic events
Taking anticoagulant agents
Uterine septum, or uterine disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Submucous leiomyoma of uterus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, tranexamic acid ampoule with a dose of 0.5 g per 1000 cc of normal saline distending medium will be used (considering that the injection dose is 1 gram and can be repeated every 6 to 8 hours and can be used in electrolyte solutions according to the manufacturer's instructions). (Manufactured by Caspian Tamin Pharmaceutical)</i_keyword>
      <i_keyword>Control group: In the control group, according to the routine, only normal saline will be used as distending medium.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemoglobin Level. Timepoint: Once before surgery and once 24 hours after surgery. Method of measurement: Blood Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of bleeding. Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Surgeon's field of view. Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Duration of surgery. Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>The amount of medium used. Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Complications during surgery (Uterine perforation). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Completing myomectomy. Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Rare side effects of Tranexamic Acid (Pulmonary embolism). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Rare side effects of Tranexamic Acid (Headache). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Rare side effects of Tranexamic Acid (abdominal cramps). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Rare side effects of Tranexamic Acid (Weakness). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Rare side effects of Tranexamic Acid (Back Pain). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Rare side effects of Tranexamic Acid (Cramps and Muscle Spasms). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Complications during surgery (Thermal injury). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Complications during surgery (Overload of distention media). Timepoint: Immediately after surgery. Method of measurement: Checklist.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-20</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
