<?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>IRCT2012090410743N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-30</date_registration>
      <primary_sponsor>Vice-chancellor for research -Jahrom University of Medical Science</primary_sponsor>
      <public_title>Meperidine effect on intraoperative and postoperative shivering of caesarean section under spinal anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Study of low dose intrathecal meperidine on intra- and post-operative shivering in caesarean section under spinal anesthesia:a prospective double-blind, randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11158</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: 10 mg bupivacaine 0.5% and 10 mg meperidine by Spinal Anesthesia (group BP, n=35). Intervention 2: placebo (10 mg bupivacaine 0.5% and normal saline, (group B, n=35) by spinal Anesthesia.</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>Hasan Zabetian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom University of Medical Sciences</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 79 1334 0405</telephone>
        <email>h_zabetian@yahoo.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Yasin Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahhari Ave, Student Research Committee, Faculty of Medicine, Jahrom University of Medical Sciences, Jahrom, I.R.Iran</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 79 1334 0405</telephone>
        <email>yasinkarami@gmail.com</email>
        <affiliation>Jahrom university of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: parturients [ASA physical status I or II]; age between 18 - 40 years old. &#13;
exclusion criteria: sever preeclampsia; contraindication to local anesthesia and caesarean section surgery; diabetes; preoperative body temperature&gt;38ᴏC (fever); allergy to the study medications (meperidine and bupivacaine); ASA III; drug addiction; height &lt;152 cm; Raynaud’s syndrome; hypo or hyperthyroidism; BMI less than 19; BMI high than 25;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O29.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of spinal and epidural anaesthesia during pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>10 mg bupivacaine 0.5% and 10 mg meperidine by Spinal Anesthesia (group BP, n=35)</i_keyword>
      <i_keyword>placebo (10 mg bupivacaine 0.5% and normal saline, (group B, n=35) by spinal Anesthesia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shivering incidence. Timepoint: Spinal Anesthesia to recovery room. Method of measurement: Crossley and Mahajan Scale.</prim_outcome>
      <prim_outcome>Shivering Intensity. Timepoint: Spinal Anesthesia to recovery room. Method of measurement: Crossley and Mahajan Scale.</prim_outcome>
      <prim_outcome>Systolic Blood Pressure. Timepoint: Start to end Of Surgery. Method of measurement: mmHg.</prim_outcome>
      <prim_outcome>Central Core Tempreture. Timepoint: Start to end Of Surgery. Method of measurement: Celcious.</prim_outcome>
      <prim_outcome>BMI. Timepoint: Start of Study. Method of measurement: KG/M2.</prim_outcome>
      <prim_outcome>APGAR Score. Timepoint: Post birth. Method of measurement: APGAR Scale.</prim_outcome>
      <prim_outcome>Highest block Segment. Timepoint: each 5 minutes during first 30 minutes of post Spinal anesthesia. Method of measurement: Pinprick.</prim_outcome>
      <prim_outcome>Diastolic Blood pressure. Timepoint: Start to end Of Surgery. Method of measurement: mmHg.</prim_outcome>
      <prim_outcome>Basic heart rate. Timepoint: Start to end Of Surgery. Method of measurement: beats per min.</prim_outcome>
      <prim_outcome>Basic peripheral oxygen saturation. Timepoint: Start to end Of Surgery. Method of measurement: Percent.</prim_outcome>
      <prim_outcome>Surgery Duration. Timepoint: Start to end Of Surgery. Method of measurement: Minute.</prim_outcome>
      <prim_outcome>Time to reach highest block. Timepoint: Anesthesia onset. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Sensory Level. Timepoint: Anesthesia onset. Method of measurement: Range.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea And Vomitting. Timepoint: Post operation. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Pruritus. Timepoint: Post operation. Method of measurement: Patient feel.</sec_outcome>
      <sec_outcome>Respiratory distress. Timepoint: During and Post operation. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Hypotension. Timepoint: During and Post operation. Method of measurement: mmHg.</sec_outcome>
      <sec_outcome>Bradycardia. Timepoint: During and Post operation. Method of measurement: Beat per minute.</sec_outcome>
      <sec_outcome>Tachycardia. Timepoint: During and Post operation. Method of measurement: Beat per minute.</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 -Jahrom University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-08-04</approval_date>
        <contact_name>Jahrom University of Medical Sciences ethics Committee</contact_name>
        <contact_address>Ostad Motahhari Street, site of  Paradise jahrom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
