<?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>IRCT20170408033280N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-12</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of intravenous Propofol, Dexamethasone and Ondansetron in preventing nausea and vomiting after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the prophylactic effect of intravenous Propofol, Dexamethasone and Ondansetron on post operative nausea and vomiting in elective cesarean section under spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into intervention and control groups using Random allocation computer software.By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients allocated into four groups according computer generated numbers, Blinding description: This study was a double-blind clinical trial. participants and researcher were unaware about the patient belonged to the interventions  or a control groups. The drugs were injected by an anesthesiologist (other than the lead researcher) who was unaware of the content of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Nausea and vomiting after cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group 1: Received 0.05 Mg/kg of Ondansetron from Kaspian-Farma company ( Iran country) after the fetus leaves and umbilical cord clamp by the surgeon. Intervention 2: Intervention group: group 2: Received 0.1 Mg/kg of Dexamethasone from Shimi-Daru company ( Iran country) after the fetus leaves and umbilical cord clamp by the surgeon. Intervention 3: Intervention group: group 3:  Received 0.2 Mg/kg of Propofol from Tehran-Shimi company (Iran country) after the fetus leaves and umbilical cord clamp by the surgeon. Intervention 4: Control group: Normal saline.</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 results of the study will be published as an article.

When:
After publishing the article

To whom:
Researchers

Conditions:
As published article

Where to obtain:
Corresponding author

How to obtain:
by email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ebrahim Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari Hospital; Kashani street; Urmia; Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3198 8293</telephone>
        <email>ehassani@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ebrahim Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahi Motahhari Hospital; Kashani street; Urmia; Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3198 8293</telephone>
        <email>ehassani@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women under cesarean section
Age group 15-35 years old
American Society of Anesthesiologists classification system I and II (ASA II and ASA II)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a history of anti depression drugs consumption
Gastrointestinal disorders
Motion sickness
Weight &gt;100 Kg
Having a history of other surgeries
Patients with preeclampsia and eclampsia during pregnancy
Taking anti-nausea and vomiting medications 24 hours before cesarean section</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</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>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group 1: Received 0.05 Mg/kg of Ondansetron from Kaspian-Farma company ( Iran country) after the fetus leaves and umbilical cord clamp by the surgeon.</i_keyword>
      <i_keyword>Intervention group: group 2: Received 0.1 Mg/kg of Dexamethasone from Shimi-Daru company ( Iran country) after the fetus leaves and umbilical cord clamp by the surgeon.</i_keyword>
      <i_keyword>Intervention group: group 3:  Received 0.2 Mg/kg of Propofol from Tehran-Shimi company (Iran country) after the fetus leaves and umbilical cord clamp by the surgeon.</i_keyword>
      <i_keyword>Control group: Normal saline</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea. Timepoint: Recovery and six hours after surgery. Method of measurement: Asking the patient.</prim_outcome>
      <prim_outcome>Vomoting. Timepoint: Recovery and six hours after surgery. Method of measurement: Push out stomach contents from the mouth.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-19</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences, Resalat Street, Jahad Ave, Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
