<?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>IRCT20170417033491N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-09</date_registration>
      <primary_sponsor>Gerash University of Medical Sciences</primary_sponsor>
      <public_title>Study the  effect of Bupivacaine 0.5% ,  Lidocaine 5%,  Pethidine  , Lidocaine 5% &amp;  intratecal on the incidence of decrease blood pressure, nausea and vomiting for elective caesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Bupivacaine 0.5% , Lidocaine 5% ,  Pethidine , Lidocaine 5%  &amp; intratecal  on the incidence of decrease  blood pressure , nausea and vometing for elective caesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25819</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple allocation by Statistical software, Blinding description: The patients will be blind to the kind of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Caesarean Section.</hc_freetext>
      <i_freetext>Intervention 1: Patients in group one received lidocaine 5% - pethedine (60 mg lidocaine 5% -15 mg pethedine as local anesthetic. Intervention 2: Patients in group two received 75 mg lidocaine 5% as local anesthetic. Intervention 3: Patients in group three received 15 bupivacaine 0.5 % as local anesthetic.</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:
Data will be coded without the names of the participants.

When:
Start the access period 6 months after publishing the results

To whom:
The published article for this study will be accessible to everyone, but other information will only be available to the sponsoring organization.

Conditions:
The published paper for this study will be accessible to everyone, but other information will only be available to the sponsoring organization

Where to obtain:
Visit the Research Deputy of the Gerash University of Medical Sciences.

How to obtain:
Visit the Research Deputy of the University of Medical Sciences. The vice chancellor will refer the applicant to the researcher if the applicant agrees.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jalal Saem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>58666 – 74417</zip>
        <telephone>+98 71 5244 8108</telephone>
        <email>saemj@sums.ac.ir</email>
        <affiliation>Gerash University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jalal Saem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>58666 – 74417</zip>
        <telephone>+98 71 5244 8108</telephone>
        <email>saemj@sums.ac.ir</email>
        <affiliation>Gerash University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 45 - 18 years
Term pregnancy (42-37 weeks)
Willingness to participate in the study
NPO (Nil Per Os)
ASA I
Elective caesarean section</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Operation duration more than 80 minutes
Using ritodrine or other beta tocolytic
Fetal abnormalities or pregnancy complications
Failure in performing spinal
Low level of blocks (block level lower than T8)
Stomachache; metabolic diseases; hypertension; nausea and vomiting before surgery
Any underlying diseases
Complications during surgery
Arterial or venous disease in lower extremities
Defects in the immune system and gestational diabetes
Smoking
Alcoholism and opium addiction
Malnutrition
Anemi</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O.82.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery by elective caesarean section</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in group one received lidocaine 5% - pethedine (60 mg lidocaine 5% -15 mg pethedine as local anesthetic.</i_keyword>
      <i_keyword>Patients in group two received 75 mg lidocaine 5% as local anesthetic.</i_keyword>
      <i_keyword>Patients in group three received 15 bupivacaine 0.5 % as local anesthetic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people who have nausea and vomiting during surgery. Timepoint: During surgery and then until the end of the recovery. Method of measurement: Observasion.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Measure and record pulse rate, mean, systolic and diastolic blood pressure immediately after the block (during surgery) every 3 to 15 minutes and then every 5 minutes until the end of the recovery. Method of measurement: Automatic sphygmomanometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Itching. Timepoint: Every 3 to 15 minutes and then every 5 minutes until the end of the recovery. Method of measurement: Observasion.</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>Gerash University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-02</approval_date>
        <contact_name>Ethics committee of Gerash University of Medical Sciences</contact_name>
        <contact_address>Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran Gerash Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
