<?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>IRCT2012100811020N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-02-18</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences, Deputy of Research</primary_sponsor>
      <public_title>Effect of different methods of remifentanil administration in labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Incremental Bolus and Infusion Administration of Remifentanil on Labor Pain and Length of Delivery Time in Women During Labor.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11381</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Single spontaneous delivery.</hc_freetext>
      <i_freetext>Intervention 1: If the intensity of pain reaches to 7 or more (based on verbal numeric grading criteria) in group A, remifentanil (in method of incremental infusion) will be prescribed from 0.025 microgram per kg of body weight of the patients in minute and If needed its dose gradually increases to 0.05, 0.075, and 0.1. &#13;
For  preparing, 1 mg remifentani is diluted into 100 ml of normal saline in solution (concentration of 10 micrograms per milliliter). Intervention 2: If the intensity of pain reaches to 7 or more (based on verbal numeric grading criteria) in group B, remifentanil (in method of incremental bolus) will be prescribed in dose of  0.25 microgram per kg, and If needed another bolus will be received in dose of 0.5 microgram per kg. lockout time between two boluses was 4 minutes. For  preparing, 1 mg remifentani is diluted into 100 ml of normal saline in solution (concentration of 10 micrograms.</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 Khooshide</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash women's hospital, Baghdarnia Avenue, shahid Bagheri highway, Resalat highway, Tehranpars</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7788 3288</telephone>
        <email>khooshide@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Khooshide</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash women's hospital, Baghdarnia avenue, shahid bagheri highway, Resalat highway, Tehranpars</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7788 3196</telephone>
        <email>khooshide@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: primigravid healthy parturient with 37-42 weeks of pregnancy; in active stage of labor (uterine contraction 3 per 10 minutes, lasting for 30 to 40 seconds and cervical dilation &gt;=3 cm); with vertex presentation.   Exclusion criteria: parturient with positive history of preeclampsia; using psychiatric drugs; using opioid and alcohol; antenatal hemorrhage; fetal distress; BMI&gt;30 or &lt;20; multi tone and requesting for epidural analgesia.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>cases with minimal or no assistance, with or without episiotomy</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>If the intensity of pain reaches to 7 or more (based on verbal numeric grading criteria) in group A, remifentanil (in method of incremental infusion) will be prescribed from 0.025 microgram per kg of body weight of the patients in minute and If needed its dose gradually increases to 0.05, 0.075, and 0.1. &#13;
For  preparing, 1 mg remifentani is diluted into 100 ml of normal saline in solution (concentration of 10 micrograms per milliliter).</i_keyword>
      <i_keyword>If the intensity of pain reaches to 7 or more (based on verbal numeric grading criteria) in group B, remifentanil (in method of incremental bolus) will be prescribed in dose of  0.25 microgram per kg, and If needed another bolus will be received in dose of 0.5 microgram per kg. lockout time between two boluses was 4 minutes. For  preparing, 1 mg remifentani is diluted into 100 ml of normal saline in solution (concentration of 10 micrograms.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of uterine contractions pain. Timepoint: Every 15 minutes from the onset of active phase of labor to delivery. Method of measurement: verbal numeric rating scale (VNRS).</prim_outcome>
      <prim_outcome>First stage of labour duration. Timepoint: every 15 minutes in first stage of labour from 4 cm dilation up to 10 cm,  and in second stage from 10 cm dilation up to delivery. Method of measurement: Time by minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Grading of sedation. Timepoint: every 15 minutes. Method of measurement: Modified Observer's Assessment of Alertness.</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>Zahedan University of Medical Sciences, Deputy of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-11-07</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Zahedan University of Medical Sciences, Dr Hesabi Sq. Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
