<?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>IRCT20180210038681N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-01</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dexamethasone and endonestrone premedication on the incidence of nausea and vomiting after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effects of Dexamethasone and Ondansetron on nausea and vomiting in cesarean section under spinal anesthesia by Bupivacaine (Marcaine)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29582</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples were selected purposefully and were assigned to the study groups using the stratified randomized blocks. nullipara/multi para pregnancy is considered as strata in this study, Blinding description: The Anesthesiologist was not aware of the type of drug used to prevent nausea and vomiting. The information was provided as a checklist and given to the inquirer who was not informed about the type of drugs for the patients. The incidence of nausea and vomiting in the patient was recorded 0 , 2 and 6 hours later in the PACU.</study_design>
      <phase>3</phase>
      <hc_freetext>nausea and vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (1) used single bolus dose  of Dexamethasone (8 mg ) simultaneously with prep and drep, after spinal anesthesia with bupivacaine (0.5% ) and spinal needle 25 gauge. Intervention 2: Intervention group (2) used single bolus dose of ondansetrone (4 mg ) simultaneously with prep and drep, after spinal anesthesia with bupivacaine (0.5% ) and spinal needle 25 gauge.</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:
The patients are divided into two groups A and B, and personal information of the patients remains confidential with the researcher.

When:
After completing the study, the information is presented in an article and immediately available to the public.

To whom:
The results are publicly available after printing and publication.

Conditions:
An analysis of the data delivered is authorized by the written permission of the persons in the article.

Where to obtain:
After publication of the article, people can submit articles by visiting Khorramabad University of Medical Sciences or through their respective websites.

How to obtain:
Immediately after referring to the Khorramabad University of Medical Sciences or the relevant websites, the article is available to the referring.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jahanbahsh rezanejadei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedicine and Nutriton Campus, Next to the social security hospital, eastern Goldasht</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819789741</zip>
        <telephone>+98 66 3342 0030</telephone>
        <email>rezanezhdi.j@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jahanbakhsh Razanejadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedicine and Nutriton Campus, Next to the social security hospital, eastern Goldasht</address>
        <city>khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819789741</zip>
        <telephone>+98 66 3340 6099</telephone>
        <email>rezanezhadi.j@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients who have attended for elective cesarean section
In the ASA class one and two
being in fertility age
Patients with normal, mild or moderate stress, anxiety and depression level
Patients who will undergo spinal anesthesia with bupivacaine 0.5%</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients suffering from pregnancy toxicity ( eclampsia- preclampsia) or history of motion sickness, history of meniere disease, and migraine
BMI greater than 40
history of PONV( post opreative neusea and vomiting )
severe or very severe level  Stress , anxiety and depression
Cigarette smoking and  opoid drug consumption
Patients that donot to cooperate
Patients who  undergo spinal anesthesia with  lidocaine 5%
Patients who  receive atropine during opreation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group (1) used single bolus dose  of Dexamethasone (8 mg ) simultaneously with prep and drep, after spinal anesthesia with bupivacaine (0.5% ) and spinal needle 25 gauge.</i_keyword>
      <i_keyword>Intervention group (2) used single bolus dose of ondansetrone (4 mg ) simultaneously with prep and drep, after spinal anesthesia with bupivacaine (0.5% ) and spinal needle 25 gauge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea. Timepoint: In PACU (at 0 oclock) and 2 oclock and after 6 oclock, the incidence of nausea and vomiting in the patient. Method of measurement: VAS ( Visual analog scale ).</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: At PACU (at the begining) and 2 hours and 6 hours later. Method of measurement: Interview with patient.</prim_outcome>
      <prim_outcome>Stress, depression and anxiety. Timepoint: In the recovery before surgery. Method of measurement: Depression‚ Anxiety‚ Stress Scale (DASS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-31</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Haj Karim Asali charity Hospital, at the begining of Felestin alley, Doctor Shariati Avenue Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
