<?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>IRCT20220102053602N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-16</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Effectiveness of Oral and Vaginal Misoprostol Administration for Cervical Ripening in Women Before Operative Hysteroscopy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Effectiveness of Oral and Vaginal Misoprostol Administration for Cervical Ripening in Women Before Operative Hysteroscopy: A Double-Blind Randomized Placebo Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To perform randomization in the samples, we use the block method with six blocks.
From the following blocks, we first select one at random and divide the samples into 3 groups according to the order.
(A for the vaginal group and B for the oral group and C for the placebo group)
C	C	B	B	A	A	1

A	C	C	B	B	A	2

A	A	C	C	B	B	3

B	A	A	C	C	B	4

B	B	A	A	C	C	5

C	A	A	B	B	C	6, Blinding description: All patients and physicians evaluating the interventions designed in the study or the consequences after the procedure (gynecology assistant and gynecological laparoscopic surgery fellowship) will not be aware of the group in which the patient is being examined. All interventions in all three groups will be designed similarly and the process will be the same on all samples in all groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Cervical Ripening.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Misoprostol 400 micrograms tablets vaginally (2 pieces 200 micrograms, Samisaz pharmaceutical company, Iran ) and B6 tablets orally (2 pieces, Aminpharma  company, Iran ). Intervention 2: Intervention group: B6 tablets vaginally (2 pieces) and misoprostol 400 mg tablets orally (2 pieces of 200 micrograms). Intervention 3: Control group: B6 tablets orally and B6 tablets vaginally (two each).</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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
Start of access period 6 months after printing results

To whom:
It will be available to researchers working in academic and scientific institutions.

Conditions:
Use of data to complete the research process on the effects of oral and vaginal misoprostol on cervical preparation in hysteroscopic women

Where to obtain:
Contact the author of the article responsible for the research project data.

How to obtain:
Contact the author of the article responsible for the research project data.Specify the type of results requested.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Atefeh Mehralitabar Firoozjah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Shast Kola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3220 2565</telephone>
        <email>atefehfiroz@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Atefeh Mehralitabar Firoozjah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Shast Kola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3220 2565</telephone>
        <email>atefehfiroz@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Based on the indications for hysteroscopy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Contraindications for anti-prostaglandin drugs (asthma, or glaucoma)
Women who are contraindicated for hysteroscopy (pregnancy, inflammatory bowel disease, malignancy)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N93.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal uterine and vaginal bleeding, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Misoprostol 400 micrograms tablets vaginally (2 pieces 200 micrograms, Samisaz pharmaceutical company, Iran ) and B6 tablets orally (2 pieces, Aminpharma  company, Iran )</i_keyword>
      <i_keyword>Intervention group: B6 tablets vaginally (2 pieces) and misoprostol 400 mg tablets orally (2 pieces of 200 micrograms)</i_keyword>
      <i_keyword>Control group: B6 tablets orally and B6 tablets vaginally (two each)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical Ripening. Timepoint: 12 Hours. Method of measurement: Hegar dilator.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-03</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
