<?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>IRCT2013040912958N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-06-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Misoprostol in therapeutic abortion</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison of vaginal and sub-lingual misoprestol for induction of therapeutic abortion at 12- 20 weeks gestational age  2012-13</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>480</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12938</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Therapeutic abortion.</hc_freetext>
      <i_freetext>Intervention 1: In group A, patients received 400 mg of  sub-lingual misoprestol every 6 hours to induce  abortion and administration was discontinued in cases of severe contraction. Intervention 2: Group B, received  400 mg of vaginal tablet of misoprestol,  placing in the vagina every 6 hours and treatment carried on until delivery of fetus or induction of severe contractures.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazila Mesbah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr.Ali Shariati Hospital, North Karegar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 8490 2414</telephone>
        <email>nazila.mesbah@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazila Mesbah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr.Ali Shariati, North Karegar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 8490 2414</telephone>
        <email>nazila.mesbah@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :&#13;
 All pregnant women with gestational age between 12 and 20 weeks who have medical indications for pregnancy termination 20-40 years old including fetal indications like structural or chromosomal fetal abnormalities, PROM, intrauterine fetal death or maternal indication such as pregnant women with hemoglobin less than 10 mg.  &#13;
Exclusion Criteria:&#13;
 pregnant women with any type of allergic reaction to misoprestol,&#13;
 pregnant women high risk for rupture of uterine,&#13;
 history of classic uterine incision or T-shaped incision, &#13;
women with a history of extensive surgery on the fundus of the uterus, pregnant women with IUD,&#13;
 women with certain medical conditions such as severe anemia, clotting disorders or taking anticoagulant medication, active liver disease, glaucoma, uncontrolled seizure disorders, adrenal disease or disorder that requires treatment with glucocorticoids such as tracheobronchial asthma, &#13;
Smoking more than 20 cigarettes per day,&#13;
 gynecologic abnormalities confirmed by ultrasound, mitral stenosis,&#13;
 sickle cell anemia,&#13;
 diastolic blood pressure more than 90 mm Hg, systolic pressure less than 90 mmHg, &#13;
history of thromboembolism and liver disease, hemolytic disorders and a history of two cesareans.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Therapeutic Abortion</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>In group A, patients received 400 mg of  sub-lingual misoprestol every 6 hours to induce  abortion and administration was discontinued in cases of severe contraction.</i_keyword>
      <i_keyword>Group B, received  400 mg of vaginal tablet of misoprestol,  placing in the vagina every 6 hours and treatment carried on until delivery of fetus or induction of severe contractures.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complete evacuation of products of conception. Timepoint: 24-48 h. Method of measurement: Questinaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulse rate. Timepoint: 24 and 48 hr. Method of measurement: examination.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: 24 and 48 hr. Method of measurement: examination.</sec_outcome>
      <sec_outcome>Uterine contraction. Timepoint: 24 and 48 hr. Method of measurement: examination.</sec_outcome>
      <sec_outcome>Mean induction to delivery time. Timepoint: 24 and 48 hr. Method of measurement: Questionaire.</sec_outcome>
      <sec_outcome>Occurrence of side effects. Timepoint: 24 and 48 hr. Method of measurement: Questionaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-26</approval_date>
        <contact_name>Ethics Committee, Faculty of Medicine</contact_name>
        <contact_address>Faculty of Medicine, Tehran University of Medical Sciences and Health Care Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
