<?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>IRCT20100525004025N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-15</date_registration>
      <primary_sponsor>Research deputy Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of misoprostol plus isosorbide mononitrate and misoprostol plus placebo in induction of second trimester abortion</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Misoprostol plus Isosorbide Mono Nitrate and Misoprostol plus placebo at the end of second trimester pregnancy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: If patients complete Informed consent, they are divided into two intervention groups (Misoprostol +Isosorbide Mononitrate) and the placebo group (Misoprostol + Placebo) . Patients do not know the type of drug they receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Termination of pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: In group A(control), vitamin B6, 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, misoprostol 400mcg, equivalent to two 200mcg tablets  stained with saline will be inserted . Intervention 2: In group B(case) Isosorbide Mononitrate 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, Misoprostol 400mcg stained with saline will be inserted.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mona Khorami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah University of Medical Sciences Sorkhe Lyzheh- Imam Reza Teaching hospital-Office of Women's Education</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714415333</zip>
        <telephone>+98 83 3427 6301</telephone>
        <email>saeedkhorami87@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Anisodowleh Nankali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah University of  Medical Science- Sorkhe Lyzheh- Imam Reza  Teaching Hospital-Office Of Women's Education</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714415333</zip>
        <telephone>+98 83342763018</telephone>
        <email>anankali@kums.ac.ir</email>
        <affiliation>Kermanshah university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age 22-13 weeks can be a condition for entering the study.
nulliparous  Can be a condition for entering the study.
Multiparous to parity 5 Can be a condition for entering the study.
singleton pregnancy can be a condition for entering the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with contra indication of misoprostol (active Cardiac-pulmonary disease, Placenta Previa, history of 2 or more previous cesarean section, or history of major uterine surgeries such as myomectomy and uterine reconstruction surgery)Conditions for not admitting to study.
Women with contraindication of Isosorbide mono nitrate (IMN) (sensitivity to nitrates, hypotension, hypovolemia, heart disease, significant anemia Hb below 7 gr / dl and closed angle glaucoma )Conditions for not admitting to study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy with abortive outcome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In group A(control), vitamin B6, 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, misoprostol 400mcg, equivalent to two 200mcg tablets  stained with saline will be inserted .</i_keyword>
      <i_keyword>In group B(case) Isosorbide Mononitrate 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, Misoprostol 400mcg stained with saline will be inserted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The abortion rate is 12 hours. Timepoint: 12 hours later intervention. Method of measurement: View the disposal of pregnancy products.</prim_outcome>
      <prim_outcome>The abortion rate is 24-12 hours. Timepoint: Abortion after 12 hours to 24 hours of intervention. Method of measurement: View the disposal of pregnancy products.</prim_outcome>
      <prim_outcome>Abortion rate after 24 hours. Timepoint: In the 24th hour of the intervention. Method of measurement: View the disposal of pregnancy products.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea. Timepoint: Every 4 hours after intervention   until the Disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</sec_outcome>
      <sec_outcome>Diarrhea. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</sec_outcome>
      <sec_outcome>Fever and chills. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</sec_outcome>
      <sec_outcome>Headache. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</sec_outcome>
      <sec_outcome>Heart beat. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</sec_outcome>
      <sec_outcome>Confusion. Timepoint: Every 4 hours after intervention until the disposal of pregnancy products. Method of measurement: See Symptoms of the patient.</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>Research deputy Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-14</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah, Nursing Blvd, Sorkhe Lyzheh, Imam Reza Teaching Hospital, Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
