<?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>IRCT201012185414N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-08-24</date_registration>
      <primary_sponsor>Vice chancellor for research, Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of  Labetalol versus Hydralazin in control of Hypertension in preeclamptic patients and the out come of their pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  Labetalol versus Hydralazin in control of Hypertension in preeclamptic patients and the out come of their pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>190</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5811</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Hydralazin prescription in a 5 mg dose as first dose and blood pressure control after 20 minutes by first degree resident and repeat the same dose every 20 minutes up to 3 doses. Intervention 2: Labetalol prescription in a 20 mg dose as first dose and blood pressure control after 20 minutes by first degree resident and repeat the complimentary doses as 40 mg and 80 mg every 20 minutes up to 3 doses.</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.Zohreh Tabasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shabihkhani Hospital, Beheshti avenue</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 36144460180</telephone>
        <email>tabasi_z @kaums.ac.ir; narges_oghbaee@yahoo.com</email>
        <affiliation>Kashan University of Medical Sience</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Zohreh Tabasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shabihkhani Hospital, Beheshti avenue</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 36144460180</telephone>
        <email>tabasi_z@kaums.ac.ir; narges_oghbaee@yahoo.com</email>
        <affiliation>Kashan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Every pregnant woman by gestational age 20  to 42  weeks with a BP&gt;160/105, singleton, estimated fetal weight &lt; 4500 g&#13;
 Exclusion criteria: &#13;
1. History of basic chronic diseases ,including chronic HTN, hyperthyroidism, arrhythmia&#13;
 2. Non cephalic presentation, macrosomia, thick meconium, previous history of caesarian section or uterine rupture which abdicate the option of NVD of patients. 3. History of long infertility, stillbirth, anomalous child, every reason for high risk pregnancy.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>016-010</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ادم, پروتئینوری و اختلالات فشار خون در حاملگی, وضع حمل و نفاس</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Hydralazin prescription in a 5 mg dose as first dose and blood pressure control after 20 minutes by first degree resident and repeat the same dose every 20 minutes up to 3 doses</i_keyword>
      <i_keyword>Labetalol prescription in a 20 mg dose as first dose and blood pressure control after 20 minutes by first degree resident and repeat the complimentary doses as 40 mg and 80 mg every 20 minutes up to 3 doses</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hydralazin effect on control of Hypertension. Timepoint: 20minuts. Method of measurement: Mercurial Barometer.</prim_outcome>
      <prim_outcome>Labetalol effect on control of Hypertension. Timepoint: 20 minutes. Method of measurement: Mercurial Barometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal pulse rate control. Timepoint: 20minutes. Method of measurement: Maternal pulse rate control.</sec_outcome>
      <sec_outcome>Average decreased amount of systolic blood pressure after Hydralazin administration. Timepoint: 20 minutes. Method of measurement: Mercurial Barometer.</sec_outcome>
      <sec_outcome>Average decreased amount of diastolic blood pressure after Hydralazin administration. Timepoint: 20 minutes. Method of measurement: Mercurial Barometer.</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>2010-11-24</approval_date>
        <contact_name>Kashan University of Medical Science; Ethics committee</contact_name>
        <contact_address>Pezeshk blvd,  Ghotbe Ravandi blvd, Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
