<?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>IRCT20120915010841N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-23</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Determination of effective drug in prevention of post spinal  hypotension in C/S</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Intravenous bolus Phenylephrine and Ephedrine for prevention of postspinal Hypotension during Cesarean section.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29134</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the randomization method is used as a 4-blocks.  In this way, according to the sample size, 20 blocks of four are identified, and in each of these blocks of four, two of each group will be written in the form of letters A or B. This means that two A and two B are written in each block, although the order of the writing of the four letters A and B will be different in each block. The periodic numbers table will then be used to determine the order of block selection, Blinding description: Ephedrine (10 mg) and phenylephrine (100 μg) in the same volumes (1 ml) are prepared in the same syringes by the anesthetist nurse according to the list of patients entered into the study (based on the four blocks) and then administered intravenously after spinal anesthesia. . Therefore, the anesthetist,  the patient and the person evaluating the outcome (anesthetist) are not familiar with the type of prescribed medication.</study_design>
      <phase>2-3</phase>
      <hc_freetext>post spinal anaesthesia hypotension.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group : In this  group immediately after the spinal anesthesia, 10 mg  (1ml)  of ephedrine which is a vaoconstrictor for prevetion of hypotension  is injected intravenously. Intervention 2: Second intervention group :  In this  group immediately after the spinal anesthesia, 100 ug (1ml)  of ephedrine which is a vaoconstrictor for prevetion of hypotension is injected intravenously.</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 Because the study is not finished yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Manouchehrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemieh Hospital, Pasdaran Street.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517789971</zip>
        <telephone>+98 81 3827 7012</telephone>
        <email>manouchehrian@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Manouchehrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemieh Hospital,  Pasdaran Street.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517789971</zip>
        <telephone>+98 81 3827 7012</telephone>
        <email>manouchehrian@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ASA CLASS 1(Healthy Patients)
18-45 aged pregnant patients for C/S</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiac disease
Renal disease
History of hypertensive disease
Diabetes
Eclampsia &amp;pre eclampsia
Multiple pregnancy
C/S for meconium or fetal distress
Contraindications for spinal anesthesia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O74.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of spinal and epidural anaesthesia during labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group : In this  group immediately after the spinal anesthesia, 10 mg  (1ml)  of ephedrine which is a vaoconstrictor for prevetion of hypotension  is injected intravenously.</i_keyword>
      <i_keyword>Second intervention group :  In this  group immediately after the spinal anesthesia, 100 ug (1ml)  of ephedrine which is a vaoconstrictor for prevetion of hypotension is injected intravenously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after  spinal anesthesia. Method of measurement: Automatic non-invasive blood pressure device.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after  spinal anesthesia. Method of measurement: Automatic non-invasive blood pressure device.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after  spinal anesthesia. Method of measurement: Automatic non-invasive blood pressure device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after  spinal anesthesia. Method of measurement: Pulse oximetry device.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after  spinal anesthesia. Method of measurement: Pulse oximetry device.</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: During surgery. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Apgar Score of neonate. Timepoint: The first and fifth minutes after birth. Method of measurement: Examination  and calculation on Apgar score.</sec_outcome>
      <sec_outcome>The amount of ephedrine have been consumed. Timepoint: during surgery. Method of measurement: The amount of ephedrine have been consumed by mg.</sec_outcome>
      <sec_outcome>The amount of atropine have been consumed. Timepoint: during surgery. Method of measurement: The amount of atropine have been consumed by mg.</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>Hamedan University of Medical Sciences, vice chancellor of research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-25</approval_date>
        <contact_name>Ethics committee of Hamadan university of Medical Sciences</contact_name>
        <contact_address>Fahmide Street Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
