<?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>IRCT20091023002624N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of isosorbide mononitrate on cervical ripening</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of isosorbide mononitrate on cervical ripening in outpatient pregnant women with unfavorable cervix.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>142</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible women were randomly assigned into two groups of drug and placebo. Randomization was performed using sealed envelopes and participants were divided in four blocks; A, B, C, D. Groups A and C received drug and groups B and D received placebo, Blinding description: Researcher, patients and outcome assessors, were not aware of the groups to which participants were allocated.  The placebo was completely similar to isosorbide mononitrate in shape, taste and smell, and was made by the same manufacturer.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Cervical ripening in pregnancy. Condition 2: Prolonged pregnancy. Condition 3: Failed medical induction of labour.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Two capsules of 50 mg isosorbide-5-mononitrate were inserted in the posterior vaginal fornix in two consecutive days (50 mg per day). Intervention 2: Control group: Two capsules of placebo, were inserted in the posterior vaginal fornix by the researcher in two consecutive days (50 mg per day).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi Ave., Molavi Cross.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1168743514</zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamkashanian@yahoo.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi AVE., Molavi Cross.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1168743514</zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamkashanian@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant
Gestational age of 39 - 41 weeks
Intact membrane
Bishop Score &lt; 6
Singleton
Cephalic presentation
Maternal age between 18- 40 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Anti-hypertensive therapy
Fetal death
Known hypersensitivity to isosorbide mononitrate
Aortic stenosis
Obstructive myocardial hypertrophy
Systolic blood pressure&lt; 95 mm Hg
Cardiovascular collapse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O34.4</hc_code>
      <hc_code>O48.1</hc_code>
      <hc_code>O61.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal care for other abnormalities of cervix</hc_keyword>
      <hc_keyword>Prolonged pregnancy</hc_keyword>
      <hc_keyword>Failed medical induction of labor</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>Intervention group: Two capsules of 50 mg isosorbide-5-mononitrate were inserted in the posterior vaginal fornix in two consecutive days (50 mg per day).</i_keyword>
      <i_keyword>Control group: Two capsules of placebo, were inserted in the posterior vaginal fornix by the researcher in two consecutive days (50 mg per day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bishop scores 48 hours after intervention. Timepoint: 48 hours after intervention. Method of measurement: Vaginal examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequency of vaginal delivery. Timepoint: At birth. Method of measurement: Data sheets.</sec_outcome>
      <sec_outcome>Gestational age at the onset of spontaneous labor. Timepoint: Onset of spontaneous labor. Method of measurement: Data sheets.</sec_outcome>
      <sec_outcome>Interval between intervention to delivery. Timepoint: At delivery. Method of measurement: Data sheets.</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>2016-05-09</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway, Chamran Highway Cross. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
