<?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>IRCT201204079399N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-15</date_registration>
      <primary_sponsor>Vice chancellor for research  ,Kashan University of Medical Sciences</primary_sponsor>
      <public_title>A placebo-controlled clinical trial to assess efficacy of tranexamic acid in reducing   hemorrhage after vaginal  delivery</public_title>
      <acronym></acronym>
      <scientific_title>A placebo-controlled clinical trial to assess efficacy of tranexamic acid in reducing   hemorrhage after vaginal  delivery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>postpartum hemorrhage.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group , 1gram of tranexamic acid diluted in 20ml Dextrose 5%  will be administered intravenously  soon after neonatal delivery.  Blood pressure, pulse rate will be checked, 1 hour and 2 hours  after delivery. Hemoglobin levels will be measured promptly at the time of admission and also 24 hours after delivery.The studied parturients will be evaluated 24 hours after normal vaginal delivery in terms of drug induced complications . Maternal outcomes such as need to transfusion , surgery ,hysterectomy or death if occur  will be documented . Intervention 2: In the control group , 20ml Dextrose 5%  and placebo(normal saline) will be administered intravenously  soon after neonatal delivery.    Blood pressure, pulse rate will  be checked, 1 hour and 2 hours after delivery.Hemoglobin levels  will be measured promptly at the time of admission and also 24 hours after delivery. The studied parturients will be evaluated 24 hours after normal vaginal delivery in terms of drug induced complications .  Maternal outcomes such as need to transfusion , surgery ,hysterectomy or death if occur  will  be documented .</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Fereshteh Heidari Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences 5th km of Ghotberavandi blvd.  Kashan  Iran</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/88141</zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>heidarifereshteh@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mansureh Samimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital  5th km of Ghotberavandi blvd.  Kashan  Iran</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/88141</zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>m_samimi@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- inclusion criteria:&#13;
   - women with term, singleton pregnancy  candidate for the first vaginal delivery&#13;
      -No history of sever medical complications involving the heart,brain ,kidney&#13;
   - No history of allergy to tranexamic acid&#13;
   -No history of visual problem&#13;
   -No history of sever pregnancy complications such as preeclampsia&#13;
   -No history of thromboembolic events&#13;
&#13;
 2- exclusion criteria:&#13;
   -patient avoidance&#13;
   -placenta abruption</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>072.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Haemorrhage following delivery of placenta</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the experimental group , 1gram of tranexamic acid diluted in 20ml Dextrose 5%  will be administered intravenously  soon after neonatal delivery.  Blood pressure, pulse rate will be checked, 1 hour and 2 hours  after delivery. Hemoglobin levels will be measured promptly at the time of admission and also 24 hours after delivery.The studied parturients will be evaluated 24 hours after normal vaginal delivery in terms of drug induced complications . Maternal outcomes such as need to transfusion , surgery ,hysterectomy or death if occur  will be documented .</i_keyword>
      <i_keyword>In the control group , 20ml Dextrose 5%  and placebo(normal saline) will be administered intravenously  soon after neonatal delivery.    Blood pressure, pulse rate will  be checked, 1 hour and 2 hours after delivery.Hemoglobin levels  will be measured promptly at the time of admission and also 24 hours after delivery. The studied parturients will be evaluated 24 hours after normal vaginal delivery in terms of drug induced complications .  Maternal outcomes such as need to transfusion , surgery ,hysterectomy or death if occur  will  be documented .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemoglobin. Timepoint: Before and 24 hours after delivery. Method of measurement: laboratory.</prim_outcome>
      <prim_outcome>Maternal death. Timepoint: During 24 hours after delivery. Method of measurement: outcome form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood transfusion. Timepoint: 24 hours after delivery. Method of measurement: outcome form.</sec_outcome>
      <sec_outcome>Thromboembolic events in mother. Timepoint: 24  hours after delivery. Method of measurement: physical exam.</sec_outcome>
      <sec_outcome>Surgical intervention. Timepoint: 24 hours after delivery. Method of measurement: outcome form.</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 chancellor for research  ,Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-30</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences   5th km of ghotberavandi blvd.  Kashan  Iran Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
