<?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>IRCT20220502054722N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-26</date_registration>
      <primary_sponsor>Vice-Chancellery for Research, Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>Metoclopramide versus ondansetron for preventing nausea and vomiting after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Metoclopramide and ondansetron for preventing nausea and vomiting after cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65020</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization with individuals as units of randomization along with allocation concealment: 150 opaque envelopes and 150 cards with the names of the groups (A, B, C) will be prepared (50 cards for each group). The cards will be put into the envelopes, and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled, and one will randomly be selected. The patient will be allocated to groups A, B, or C based on the card inside the selected envelope, Blinding description: Metoclopramide, ondansetron, and normal saline have the same color, and an identical volume of these drugs (10 ml) will be administered. These drugs will be prepared in similar vials by an individual uninvolved in the study. Therefore, the patients, the caregivers, the investigator, and the outcome assessor will be unaware of the injected drug for each patient.</study_design>
      <phase>3</phase>
      <hc_freetext>Post-operative nausea and vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 5 minutes before spinal anesthesia, intravenous metoclopramide 10 mg/2 ml (DarouPakhsh Co., Iran) diluted with 8 ml normal saline will be injected within 2 minutes. Intervention 2: Intervention group 2: 5 minutes before spinal anesthesia, intravenous ondansetron 4 mg/2 ml (Exir Co., Iran) diluted with 8 ml normal saline will be injected within 2 minutes. Intervention 3: Control group: 5 min before spinal anesthesia, 10 ml normal saline (placebo) will be injected within 2 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasan Movahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Hormozgan, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 7000</telephone>
        <email>20goodlife2020@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Movahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Hormozgan, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 7000</telephone>
        <email>20goodlife2020@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18-40 years old
ASA class I and II
Term and singleton pregnancy
Candidacy for elective cesarean section</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Contraindications of spinal anesthesia
History of postoperative nausea and vomiting
History of severe motion sickness
Gestational hypertension
History of opioid abuse
Preeclampsia
History of taking antiemetics one week before surgery
Less than six hours fasting before surgery
Emergency cesarean section</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea with vomiting, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 5 minutes before spinal anesthesia, intravenous metoclopramide 10 mg/2 ml (DarouPakhsh Co., Iran) diluted with 8 ml normal saline will be injected within 2 minutes</i_keyword>
      <i_keyword>Intervention group 2: 5 minutes before spinal anesthesia, intravenous ondansetron 4 mg/2 ml (Exir Co., Iran) diluted with 8 ml normal saline will be injected within 2 minutes</i_keyword>
      <i_keyword>Control group: 5 min before spinal anesthesia, 10 ml normal saline (placebo) will be injected within 2 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative nausea and vomiting. Timepoint: At 1, 2, 4, and 6 hours after surgery. Method of measurement: Number of episodes and severity using a visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypotension. Timepoint: Before surgery and at 1, 2, 4, and 6 hours after surgery. Method of measurement: Using a standard sphygmomanometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before surgery and at 1, 2, 4, and 6 hours after surgery. Method of measurement: Using a standard sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before surgery and at 1, 2, 4, and 6 hours after surgery. Method of measurement: Counting the heart 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-Chancellery for Research, Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-23</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, in front of Kargaran Sports Complex, Imam Hossein Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
