<?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>IRCT201702282624N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-03</date_registration>
      <primary_sponsor>Vice chancellor for research ,Iran University of Medical Sciences.</primary_sponsor>
      <public_title>Induction of labor with 3 different methods.</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between induction of labor with 3 methods of titrated oral misoprostol, constant dose of oral misoprostol and folly catheter with extra amniotic saline infusion (EASI), in women with unfavorable cervix.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2427</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Delivery. Condition 2: Outcome of delivery.</hc_freetext>
      <i_freetext>Intervention 1: In oral titrared misoprostol group:&#13;
200µg misoprostol tablet will be solved in 200 milliliter of water (this solution is stable in the room temperature and contains 1µg misoprostol in 1mlit of solution). First, 20 milt (20µg) of misoprostol will be administered hourly for 4 hours. Then in spite of not having good contractions, 40 milt (40µg) of misoprostol solution will be administered every 1 hour for 4 doses and will be repeated after 4 hours with 60mlit (60µg) of misoprostol solution for a maximum of 4 doses (in total 480µg). Intervention 2: In oral misoprostol group, 50µg misoprostol will be  administered and women will be followed up to 4 hours. FHR and uterine contractions will be checked hourly. In the cases of not having suitable contractions after 4 hours, another 50 µg of misoprostol will be  administered every 4 hours until obtaining good contractions or up to maximum 6 doses (300 µg totals). Then the women  will be   followed up to delivery. Intervention 3: In the EASI group, folly catheter of number 18 was introduced through cervical canal and was filled with 30mlit distilled water and was fixed above the internal cervical OS, and was connected to normal saline solution. The normal saline was entered the uterus with the rate of 30 drops per minute. After expulsion of folly catheter, oxytocin was started in the amount of 25 milliunits per minute and was increased every 15 minutes up to 40 milliunits 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 Road.</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 Road.</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 : maternal age between 18-40 years old; gestational age of more than 37 weeks ; singleton, cephalic presentation, intact membrane and Bishop Score of less than 6. Exclusion criteria : any sign of fetal distress;  placenta previa and any vaginal bleeding of more than bloody show; history of any surgery on uterus including cesarean section; known uterine anomaly; intra uterine fetal death, and known hypersensitivity to misoprostol.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00-O99</hc_code>
      <hc_code>Z37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy, childbirth and the puerperium</hc_keyword>
      <hc_keyword>Outcome of delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In oral titrared misoprostol group:&#13;
200µg misoprostol tablet will be solved in 200 milliliter of water (this solution is stable in the room temperature and contains 1µg misoprostol in 1mlit of solution). First, 20 milt (20µg) of misoprostol will be administered hourly for 4 hours. Then in spite of not having good contractions, 40 milt (40µg) of misoprostol solution will be administered every 1 hour for 4 doses and will be repeated after 4 hours with 60mlit (60µg) of misoprostol solution for a maximum of 4 doses (in total 480µg).</i_keyword>
      <i_keyword>In oral misoprostol group, 50µg misoprostol will be  administered and women will be followed up to 4 hours. FHR and uterine contractions will be checked hourly. In the cases of not having suitable contractions after 4 hours, another 50 µg of misoprostol will be  administered every 4 hours until obtaining good contractions or up to maximum 6 doses (300 µg totals). Then the women  will be   followed up to delivery.</i_keyword>
      <i_keyword>In the EASI group, folly catheter of number 18 was introduced through cervical canal and was filled with 30mlit distilled water and was fixed above the internal cervical OS, and was connected to normal saline solution. The normal saline was entered the uterus with the rate of 30 drops per minute. After expulsion of folly catheter, oxytocin was started in the amount of 25 milliunits per minute and was increased every 15 minutes up to 40 milliunits per minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delivery during the first 24 hours after intervention. Timepoint: 24 hours. Method of measurement: Data sheets.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of the stages of labor. Timepoint: 1 hour. Method of measurement: Data sheets.</sec_outcome>
      <sec_outcome>The adverse effects in mothers. Timepoint: each hour. Method of measurement: Data sheets.</sec_outcome>
      <sec_outcome>The adverse effects in neonates. Timepoint: After birth up to 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>2013-09-23</approval_date>
        <contact_name>Ethics committee 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>
