<?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>IRCT20210816052206N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-29</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigation and comparison of the effect of two different marcaine temperatures on shivering during and after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Investigation and comparison of the effect of two different marcaine temperatures on shivering during and after cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58301</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using Random allocationation software version 1.0 under Windows, we generate a random sequence by a simple random allocation method, Blinding description: In order to perform random allocation between the two groups, random alloction software version 1 was used under Windows. First, a sequence of random numbers from 1 to 64 with letters A, B (intervention and control) was prepared by the software. The first eligible participant The number 1 and the last person take the number 64 and it is determined based on the list of the type of treatment of the person. In order for the random allocation to be blind, the random allocation list is given to another person who is not involved in the research.</study_design>
      <phase>3</phase>
      <hc_freetext>Shivering during and after cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Women candidates for cesarean section in the age range of 20 to 38 years with GA36 up to 40 weeks under anesthesia with marcaine stored in the refrigerator. Intervention 2: Control group: Women candidates for cesarean section in the age range of 20 to 38 years with GA36 up to 40 weeks under anesthesia with marcaine stored at operating room temperature.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
This study will not have any side effects for the participants in the project

When:
Upon completion of data collection

To whom:
همه گروه های پزشکی

Conditions:
In order to achieve the optimal temperature to reduce chills and after cesarean section and prevent unwanted complications

Where to obtain:
Samples collected from women candidates for cesarean section, which will finally be handed over to the archives of Shahid Sadoughi Hospital in Yazd

How to obtain:
Request, approval and delivery from the archives of Shahid Sadoughi Hospital in Yazd

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marjan Chalabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ایران یزد میدان کاج خیابان ایثار خیابان بهاران کوچه بهاران ۱۴ پلاک ۱۴</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916885346</zip>
        <telephone>+98 35 3823 1328</telephone>
        <email>Marjan.Chalabi1614@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan chalabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ایران یزد میدان کاج خیابان ایثار خیابان بهاران کوچه بهاران ۱۴ پلاک ۱۴</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916885346</zip>
        <telephone>+98 35 3823 1328</telephone>
        <email>marjan.chalabi1614@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women candidates for cesarean section in the age range of 20 to 38 years with GA 36 to 40 weeks.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with local anesthesia, hypersensitivity to amide local anesthesia, history of headache and severe preeclampsia.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R00–R99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Women candidates for cesarean section in the age range of 20 to 38 years with GA36 up to 40 weeks under anesthesia with marcaine stored in the refrigerator</i_keyword>
      <i_keyword>Control group: Women candidates for cesarean section in the age range of 20 to 38 years with GA36 up to 40 weeks under anesthesia with marcaine stored at operating room temperature</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shivering. Timepoint: During cesarean section until the end of the patient's recovery time. Method of measurement: Specific shivering scale for neuraxial anesthesia as defined by Grassley and Mahagan 0: No chills, 1: No muscle activity is visible but there is flexibility or contraction of peripheral arteries or both 2: Muscle activity in only one muscle group 3: Moderate muscle activity in more than one muscle group but no overall vibration 4: Activity Intense muscles that involve the whole body.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Central body temperature. Timepoint: Every 5 minutes from the beginning of cesarean section for the first 20 minutes, then every 10 minutes to 30 minutes, and finally every 15 minutes until the end of the recovery time. Method of measurement: OMRON brand tympanic thermometer.</sec_outcome>
      <sec_outcome>Sensory block surface. Timepoint: Every 5 minutes from the start of cesarean section for the first 20 minutes and then every 10 minutes to 30 minutes. Method of measurement: PINPRICK test.</sec_outcome>
      <sec_outcome>Hemodynamic variables. Timepoint: Every 5 minutes from the beginning of cesarean section for the first 20 minutes, then every 10 minutes to 30 minutes, and finally every 15 minutes until the end of the recovery time. Method of measurement: Blood pressure and heart rate monitor.</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: 5 minutes after the start of cesarean section until the end of the recovery time. Method of measurement: Sick symptoms.</sec_outcome>
      <sec_outcome>Need an analgesic supplement. Timepoint: 5 minutes after the start of cesarean section until the end of the recovery time. Method of measurement: Request the patient to receive an analgesic supplement according to the symptoms.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-09</approval_date>
        <contact_name>IR.SSU.MEDICINE.REC.</contact_name>
        <contact_address>Alam Square, Shohadaye gomnam Boulevard,Shahis sadoughi University of medical Science, Yazd , Iran YAZD Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
