<?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>IRCT20190929044920N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-07</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vaginal hyoscine butyl bromide on  cervical ripening before hysteroscopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of vaginal hyoscine butyl bromide and vaginal misoprostol on cervical ripening before hysteroscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomly blocked with 4 person blocks, Blinding description: Medicines will be coded A, B, and the patient and the clinical caregiver (patient physician) will not be informed of the patient's assignment to the study groups. So the study will be double-blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Uterine polyp. Condition 2: endometrial hyperplasia. Condition 3: Submucousal fibroid. Condition 4: Abnormal uterine bleeding. Condition 5: Noninflammatory disorder of uterus, unspecified. Condition 6: Patients who are candidates for hysteroscopy.</hc_freetext>
      <i_freetext>Intervention 1: Hyosine Butyl Bromide Recipient: This drug will be given vaginally at a dose of 20 mg (2 tablets 10 mg) 4 hours before surgery. Intervention 2: Misoprostol recipient: This drug will be given vaginally at a dose of 200 μg 4 hours before surgery.</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 -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboubeh Borna</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ibn Abi Talib Hospital, Slamat Blvd., Persian Gulf Highway</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743111</zip>
        <telephone>+98 54 3329 5570</telephone>
        <email>dr.bornamah@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Borna</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ibn Abi Talib Hospital, Slamat Blvd., Persian Gulf Highway</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743111</zip>
        <telephone>+98 54 3329 5570</telephone>
        <email>dr.bornamah@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women candidates for hysteroscopy
Age between 18-65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction with continuing treatment process
Sensitivity to the drugs used
Asthma
Glaucoma
cardiovascular disease
Taking antihypertensive drugs
Sensitivity to prostaglandins</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N84.0</hc_code>
      <hc_code>N85.0</hc_code>
      <hc_code>D25.0</hc_code>
      <hc_code>N93.9</hc_code>
      <hc_code>N85.9</hc_code>
      <hc_code>N71.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polyp of corpus uteri</hc_keyword>
      <hc_keyword>Endometrial hyperplasia</hc_keyword>
      <hc_keyword>Submucous leiomyoma of uterus</hc_keyword>
      <hc_keyword>Abnormal uterine and vaginal bleeding, unspecified</hc_keyword>
      <hc_keyword>Noninflammatory disorder of uterus, unspecified</hc_keyword>
      <hc_keyword>Inflammatory disease of uterus, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Hyosine Butyl Bromide Recipient: This drug will be given vaginally at a dose of 20 mg (2 tablets 10 mg) 4 hours before surgery.</i_keyword>
      <i_keyword>Misoprostol recipient: This drug will be given vaginally at a dose of 200 μg 4 hours before surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of Dilator Hagar Crossings No. 5. Timepoint: After complete anesthesia. Method of measurement: Hagar Number Five Crossing.</prim_outcome>
      <prim_outcome>Duration of operation time. Timepoint: Duration of operation. Method of measurement: Stopwatch.</prim_outcome>
      <prim_outcome>Side effects. Timepoint: From medication to discharge. Method of measurement: Complete patient examination.</prim_outcome>
      <prim_outcome>Severity of pain. Timepoint: During surgery and half an hour after surgery. Method of measurement: The visual acuity scale (VAS)  zero to ten.</prim_outcome>
      <prim_outcome>Cervical dilatation rate. Timepoint: Check in operation. Method of measurement: Based on measurements by Hegar and hysteroscopes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of operation time. Timepoint: Duration of operation. Method of measurement: Stopwatch.</sec_outcome>
      <sec_outcome>Side effects. Timepoint: From medication to discharge. Method of measurement: Complete patient examination.</sec_outcome>
      <sec_outcome>Severity of pain. Timepoint: During surgery and half an hour after surgery. Method of measurement: The visual acuity scale (VAS) zero to ten.</sec_outcome>
      <sec_outcome>Cervical dilatation rate. Timepoint: Check in operation. Method of measurement: Based on measurements by Hegar and hysteroscopes.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-28</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Ali Ebn Abitaleb Hospital, Persian Gulf Expressway Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
