<?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>IRCT20110313006044N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-25</date_registration>
      <primary_sponsor>Vice-Chancellery for Research Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>Preload versus coload of ringer lactate to prevent hypotension during elective cesarean section under spinal anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of preload and coload of ringer lactate to prevent hypotension during elective cesarean section under spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization with individuals as units of randomization along with allocation concealment: 60 unclear envelopes and 60 cards with the names of the groups (A, B) will be prepared (30 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 group A or B  based on the card inside the selected envelope, Blinding description: Due to the difference in the interventions the participants cannot be blinded. However, the investigator and the outcome assessor will be unaware of patients' interventions.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypotension during cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the preload group will receive 10 ml/kg Ringer’s solution (Samen Pharmaceutical Co., Mashhad, Iran) within 15 min before the blockade. Intervention 2: Intervention group: Patients in the co-load group will receive 10 ml/kg Ringer’s solution (Samen Pharmaceutical Co., Mashhad, Iran) during the blockade.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hashem Jarineshin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhouri Eslami Blvd., Payambar Azam Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>hjarineshin@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hashem Jarineshin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhouri Eslami Blvd., Payambar Azam Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>979199155</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>hjarineshin@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-45 years
Singleton term pregnancy
Elective cesarean section
Spinal anesthesia
American Society of Anesthesiologists (ASA) class I or II</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Twin or multiple pregnancy
ASA class above II
Hypertension or cardiovascular diseases
Contraindications of spinal anesthesia
Hypersensitivity to bupivacaine
Renal disorders
Severe hemorrhage during surgery requiring blood transfusion
Uterine atony requiring hysterectomy
Block failure or incomplete block demanding extra anesthetics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I95</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypotension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the preload group will receive 10 ml/kg Ringer’s solution (Samen Pharmaceutical Co., Mashhad, Iran) within 15 min before the blockade</i_keyword>
      <i_keyword>Intervention group: Patients in the co-load group will receive 10 ml/kg Ringer’s solution (Samen Pharmaceutical Co., Mashhad, Iran) during the blockade</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal blood pressure. Timepoint: Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit. Method of measurement: Monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal mean arterial pressure. Timepoint: Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit. Method of measurement: Monitoring device.</sec_outcome>
      <sec_outcome>Maternal heart rate. Timepoint: Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit. Method of measurement: Monitoring device.</sec_outcome>
      <sec_outcome>Maternal oxygen saturation. Timepoint: Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit. Method of measurement: Monitoring device.</sec_outcome>
      <sec_outcome>Neonatal Apgar score. Timepoint: 1 and 5 min after delivery. Method of measurement: Clinical assessment.</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>2018-07-22</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Jomhouri Eslami Blvd., Shahid Mohammadi Hospital Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
