<?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>IRCT20150817023666N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-03</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of oxytocin and vasopressin in reducing laparoscopic myomectomy bleeding in women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of intra-myomic injection of oxytocin and intramural vasopressin in reducing laparoscopic myomectomy bleeding in women with myoma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 60 people, 30 balls for intervention group A and 30 balls for intervention group B were placed in a lottery container and then the balls were randomly pulled out from the container without replacement, Blinding description: This is a double-blind study. The participant, the data collector, and the data analyzer are blind to the type of drug. One participant receives oxytocin and the other vasopressin, and the patient is told that he or she will receive one of these two drugs, and data is sent to the analyzer named A and B, without knowing their nature.</study_design>
      <phase>3</phase>
      <hc_freetext>Bleeding during surgery.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Prophylaxis oxytocin is diluted and injected intramyometrialy (between the myoma and the uterus) and subcapsulary. For this purpose, a 10 mg ampoule is diluted with 300 cc of normal saline and 100 cc is injected. Intervention 2: Intervention group: Vasopressin is diluted with a concentration of 0.2 U / ml and totally 4-6 units is injected intramyometrialy (between myoma and uterus) and subcapsulary.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of data like the main outcome or some others could be shared

When:
Access after 6 months after publication

To whom:
Data will be available for all researchers

Conditions:
It can be used for further research and improvement of surgery. Surgeons and gynecologists can use this data.

Where to obtain:
For receiving data please be contacted with mehdizadeh.a@iums.ac.ir

How to obtain:
Send a letter to mehdizadeh.a@iums.ac.ir to provide them with the documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abolfazl Mehdizadeh Kashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Rasoul Akram Hospital; Niayesh St.; Sattar Khan St.; Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>mehdizadeh.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abolfazl Mehdizadeh Kashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Rasoul Akram Hospital; Niayesh St.; Sattar Khan St.; Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>mehdizadeh.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 20 to 45 years
Symptomatic uterine fibroids candidate for laparoscopic surgery
No response to drug treatment</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Underlying diseases related to blood factors
Pregnancy
Women who are candidates for hysterectomy
People for whom anesthesia is harmful
A history of an adverse reaction or allergy to vasopressin, and an active cardiovascular or pulmonary disease that indicates a problem with vasopressin use.
Long QT interval
Leiomyoma located in the area of the uterus that connects to the arteries or ligaments of the uterus or cervix and is difficult to remove without hysterectomy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Prophylaxis oxytocin is diluted and injected intramyometrialy (between the myoma and the uterus) and subcapsulary. For this purpose, a 10 mg ampoule is diluted with 300 cc of normal saline and 100 cc is injected.</i_keyword>
      <i_keyword>Intervention group: Vasopressin is diluted with a concentration of 0.2 U / ml and totally 4-6 units is injected intramyometrialy (between myoma and uterus) and subcapsulary.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding during surgery. Timepoint: The volume of suctioned blood is measured during the operation, after surgery and 12 hours after the operation. Method of measurement: Measurement of blood hemoglobin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fever. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</sec_outcome>
      <sec_outcome>Infection. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</sec_outcome>
      <sec_outcome>Duration of surgery. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</sec_outcome>
      <sec_outcome>Postoperative side effects such as allergies. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</sec_outcome>
      <sec_outcome>Cardiovascular disorders. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</sec_outcome>
      <sec_outcome>Pulmonary edema. Timepoint: Before and after surgery and 12 hours after surgery. Method of measurement: Patient's file (document).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-20</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hazrat Rasoul Akram Hospital; Niayesh St.; Sattar Khan St.; Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
