<?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>IRCT201403242624N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-09</date_registration>
      <primary_sponsor>Vice chancellor for research ,Iran University of Medical Sciences.</primary_sponsor>
      <public_title>Labor induction</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between the effect of oral titrated solution of misoprostol and intravenous oxitocine for labor induction in term pregnancies.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2418</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: cervical ripening. Condition 2: induction of labor. Condition 3: medical induction of labour. Condition 4: Delivery.</hc_freetext>
      <i_freetext>Intervention 1: administration of oral titrated solution of misoprostol.   200 microgram misoprostol will be solved in 200 mili liter water, and 20 cc of this solution will be prescribed every 2 hours. ( maximum 60 micro gram). Intervention 2: infusion of 2.5 mili units oxitocine per minute that will be doubled every 15 minutes. Maximum dose of oxitocine is 60 mili units per minute.</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>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi avenue, Molavi Cross.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5563 3244</telephone>
        <email>maryamkashanian@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Kashanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi avenue, Molavi Cross.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></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>Inclusion criteria: age between 20-40 year old; reliable gestational age between 40-42 weeks; singleton pregnancy with cephalic presentation; BISHOP Score of more than 5; favorable pelvis.&#13;
Exclusion criteria: parity of more than 3, blood pressure equal or more than 160/110 mmHg; abnormal NST and any sign of fetal distress; urine protein of  more than 2 gram in 24 hours;    suspicious for HELLP syndrome; poly hydramnios; probable macrosomia; any vaginal bleeding; history of any surgery on uterus; prostaglandin use during present pregnancy and beginning of spontaneous uterine contractions.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O30</hc_code>
      <hc_code>O61</hc_code>
      <hc_code>O61.0</hc_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal care related to the fetus and amniotic cavity and possible delivery problems</hc_keyword>
      <hc_keyword>Complications of labour and delivery.</hc_keyword>
      <hc_keyword>Failed medical induction of labour</hc_keyword>
      <hc_keyword>Delivery</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>administration of oral titrated solution of misoprostol.   200 microgram misoprostol will be solved in 200 mili liter water, and 20 cc of this solution will be prescribed every 2 hours. ( maximum 60 micro gram).</i_keyword>
      <i_keyword>infusion of 2.5 mili units oxitocine per minute that will be doubled every 15 minutes. Maximum dose of oxitocine is 60 mili units per minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of deliveries during the first 24 hours. Timepoint: 24 hours. Method of measurement: Data sheets.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rout of delivery. Timepoint: ---. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>Uterine hyperstimulation. Timepoint: every 30 minutes. Method of measurement: monitoring of uterine contractions- tocography.</sec_outcome>
      <sec_outcome>Fetal distress. Timepoint: every 15 minutes. Method of measurement: fetal heart rate monitoring with tococardiography.</sec_outcome>
      <sec_outcome>Neonatal Apgar Score. Timepoint: minute 1 and 5. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>Number of deliveries during 6-12-18 hours from the beginning of induction. Timepoint: 6-12-18 hours from the beginning of induction. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>Duration of stage 1 , 2 and 3 of labor. Timepoint: end of stage 1 , 2 and 3 of labor. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>Interval between the beginning of induction up to the beginning of suitable contractions( 3 forceful contractions during 10 minutes). Timepoint: every 30 minutes. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>Indications for cesarean deliveries. Timepoint: during cesarean deliveries. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>NICU admission. Timepoint: After birth up to discharge. Method of measurement: data sheets.</sec_outcome>
      <sec_outcome>Duration of hospital stay for mother and baby. Timepoint: admission , discharge. 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>Vice chancellor for research ,Iran University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-28</approval_date>
        <contact_name>Ethic comittee of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat highway, Chamran Cross Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
