<?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>IRCT20220203053929N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparative effect of nitroglycerin and misoprostol on cervical ripening before hysteroscopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of nitroglycerin and misoprostol on cervical ripening before hysteroscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61758</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization/In this study, with a sample size of 84 individuals, 42 balls for the misoprostol intervention group and 42 balls for the nitroglycerin group were placed in a lottery container and then the balls were randomly removed from the container without replacement and the sequence created was recorded, Blinding description: Outcome assessors and data analysts will not have information on how to assign groups to patients in groups A and B.  We divide the outcome assessor and the patient data analyzer into A and.  B know and do not know the nature of groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Cervical ripening before hysteroscopy.</hc_freetext>
      <i_freetext>Intervention group: nitroglycerin is used in post fornix vaginal for cervical ripening in nuli Gravid women who are candidate for hysteroscopy. In this double-blind clinical trial on 84 women in the age range of 20 to 60 years who were randomly divided into two groups of 42 people in 6-block blocks.  Two types of intervention are considered.  The first intervention group (42 patients) Pearl nitroglycerin 0.4 mg in the recovery room one to half an hour before the operation up to a maximum of 3 pearls every 5 minutes with the permission of the anesthesiologist will be implanted vaginally in the posterior cervical fornix and  For the second intervention group (42 patients), a misoprostol 200 microgram tablet is inserted in the posterior fornix 4 to 6 hours before surgery and the rate of cervical ipening is evaluated with calibrated dilators in both groups. The amount of bleeding and pain before surgery in two  Groups are compared.</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:
Comparative effect of nitroglycerin and mesoprostol in cervical ripening

When:
8months

To whom:
Cosultant Processors

Conditions:
Cervical ripening before hysteroscopy /based on relative information in proposal can be conducted

Where to obtain:
Melika.ansarin@gmail.com

How to obtain:
The implementation process of the project in Rasool Akram Hospital is eight months and after that it will be published as an article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahla mirgaloo bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No344, entrance 3 block7 phase2 Ekbatan town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1396813733</zip>
        <telephone>+98 21 4465 7764</telephone>
        <email>Melika.ansarin@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla mirgaloo bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No344, entrance 3 block7 phase2 Ekbatan town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1396813733</zip>
        <telephone>+98 21 4465 7764</telephone>
        <email>Melika.ansarin@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>: Conscious patient satisfaction, hysteroscopic women, lack of nitroglycerin sensitivity, without cardiovascular disease lack of existence of severe bleeding, as well as unstable status</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Systolic blood pressure less than ‌100 mm Hg, intravascular volume reduction, valvular heart disease, severe bleeding, multiparous (NVD 2 ≥ Gravid,) impossibility of using nitroglycerin based on anesthesiologist's sensitivity to any food preservative)  Use of hypertension or cardiac drugs for cerebral hemorrhage, anemia, glaucoma, hyperthyroidism, heart problems, heart failure, liver and kidney disease, hypotension and dissatisfaction with continuing the company</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: nitroglycerin is used in post fornix vaginal for cervical ripening in nuli Gravid women who are candidate for hysteroscopy. In this double-blind clinical trial on 84 women in the age range of 20 to 60 years who were randomly divided into two groups of 42 people in 6-block blocks.  Two types of intervention are considered.  The first intervention group (42 patients) Pearl nitroglycerin 0.4 mg in the recovery room one to half an hour before the operation up to a maximum of 3 pearls every 5 minutes with the permission of the anesthesiologist will be implanted vaginally in the posterior cervical fornix and  For the second intervention group (42 patients), a misoprostol 200 microgram tablet is inserted in the posterior fornix 4 to 6 hours before surgery and the rate of cervical ipening is evaluated with calibrated dilators in both groups. The amount of bleeding and pain before surgery in two  Groups are compared</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical ripening, bleeding measurment, gravidity, parity, abortion number andside Effects like vomiting, hypotension, dizziness, stomach pain, diarehea, fever. Timepoint: Before hysteroscopy and after using Medicine اand Side Effects after using. Method of measurement: Cervical dilation with measured dilator, bleeding Mount :pad percentage, pain score, weight :kg, gravidity :pregnancy count/parity:living birth delivery, sideeffect like diarehea, flushinv, hypotension, dizziness, headache, fever, nausea اند vomiting.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain score and Mount of bleeding and dilation after hysteroscopy. Timepoint: Before hysteroscopy and after medications. Method of measurement: Pad percentage, pain score، measurment of dilation with measured dilator bouji.</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>2022-03-26</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Science</contact_name>
        <contact_address>No344, block7, 2nd phase, Ekbatan town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
