<?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>IRCT138706061113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-03-27</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences, Zahravi drug company</primary_sponsor>
      <public_title>The effect of omega3 supplementation in preeclampsia in pregnant women at risk in Qazvin</public_title>
      <acronym></acronym>
      <scientific_title>The effect of omega3 supplementation in preeclampsia in pregnant women at risk in Qazvin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/145</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Omega-3, 1gram for 24 weeks. Intervention 2: Placebo for 24 weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>     Background :Identification of factors preventing from preeclampsia in high risk pregnant women is a significant importance.Omega-3 supplementation may reduce the risk of preeclampsia.&lt;br /&gt;&#13;
Objective : In this research was assessed the effects of Omega-3 supplementation,on high risk pregnancy for preeclampsia in Qazvin city.&lt;br /&gt;&#13;
Methods:This single-blind randomized clinical trial was conducted in Qazvin city. The sample was 100 high risk pregnant women for preeclampsia(between 14-18weeks of gestation). 50were assigned to Omega-3 group and 50 to the placebo group.Women were assigned to daily supplementation with 1000mg omega-3 or placebo until delivery.Then preeclampsia and pregnancy outcome's were assessed in two groups.After employing data were recoeded and analyzed statistically using t-test,X2,mannwhitney and fisher exact test.&lt;br /&gt;&#13;
findings :There were significant differences between the Omega-3 and Placebo groups in the rate(p=0.015) and intensity(P=0.01) of preeclampsia.The correlation was found  between the Omega-3 group and outcome of  pregnancy (birth weight and Apgar score)( P=0.000,p=0.002).&lt;br /&gt;&#13;
Conclusion :Our results suggest that supplementation with Omega-3 during pregnancy reduced the risk of preeclampsia in high risk pregnant womenThus it seems necessary to promot educational nutritiant programs for pregnant women .&lt;br /&gt;&#13;
      Keywords : high risk pregnancy,preeclampsia,fatty acids with long chins of omega3</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>Fatemeh Ranjkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>p.o.box: 34197-59811, nursing and midwifery faculty, Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 28 1377 4540</telephone>
        <email>franjkesh@qums.ac.ir</email>
        <affiliation>nursing and midwifery school</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ranjkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>p.o.box: 34197-59811, nursing and midwifery faculty, Qazvin University of Medical Sciences</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 28 1377 4540</telephone>
        <email>franjkesh@qums.ac.ir</email>
        <affiliation>nursing and midwifery school</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: pregnant women whose gestational age is between 14 to 18 weeks and are ready to cooperate, being high risk for preeclampsia (first gravidy, under the age of 20 and over 40, a history of preeclampsia during the previous gravidy or immediate member of family, BMI more than 29, history of twin fetuses); &#13;
Inclusion criteria: consumption of Aspirin, Calcium, anticoagulants, allergy to omega3 or fish, presence digestive diseases which need to treatment,</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>014</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational [pregnancy-induced] hypertension with significant proteinuria</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Omega-3, 1gram for 24 weeks</i_keyword>
      <i_keyword>Placebo for 24 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hypertention. Timepoint: Every 4 hours. Method of measurement: determination of BP by the auscullatory method.</prim_outcome>
      <prim_outcome>Proteinuria. Timepoint: daily. Method of measurement: Urine Protein.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of liver enzymes. Timepoint: daily. Method of measurement: laboratory.</sec_outcome>
      <sec_outcome>Headache. Timepoint: Every 4 hours. Method of measurement: Asking from patients.</sec_outcome>
      <sec_outcome>Thrombocytopenia. Timepoint: daily. Method of measurement: laboratory.</sec_outcome>
      <sec_outcome>Abdominal pain. Timepoint: Every 4 hours. Method of measurement: Asking from pateints.</sec_outcome>
      <sec_outcome>Vision problems. Timepoint: Every 4 hours. Method of measurement: Asking from patients.</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>Qazvin University of Medical Sciences, Zahravi drug company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-09-21</approval_date>
        <contact_name>Qazvin University of Medical Sciences, Deputy for research</contact_name>
        <contact_address>Deputy for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd. Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
