<?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>IRCT20100701004281N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Fish Oil Supplement on Pregnancy Outcome in Women with a History of High-risk Pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Fish Oil Supplement on Pregnancy Outcome in Women with a History of High-risk Pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In order to assign patients to two groups of intervention and control, block randomization method with the size of four random blocks was used and randomization sequence was performed in the central committee.The sequence of randomization using web-based randomization is done through the following site:
https://www.Randomization.com, Blinding description: In this study, participants were unaware of the study group they were in (intervention or control).
Also, the evaluation of the study results (pregnancy outcomes) was performed by a person outside the research team.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Increase of blood pressure during current pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Soft capsule of 1000 mg salmon oil (Omega 3), without mercury, containing essential fatty acids (fish oil and flaxseed oil) made in Iran, Zahravi Pharmaceutical Company, each capsule of which contains 180 mg of eicosapentaenoic acid and 120 mg Ducosahexaenoic acid, and from the 16th week to the end of pregnancy, one capsule a day was given and it was recommended to be taken orally with food and water; Routine pregnancy care was also provided for this group. Intervention 2: Control group: No intervention was performed and they only received routine pregnancy care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is not further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Kiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, School of nursing and Midwifery, 7 Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>kiani.m89@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Robabeh Taheripanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 10, Second Floor, Green Building, at the beginning of Zafar, Dr. Shariati St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 21 2222 3327</telephone>
        <email>info@taheripanah.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian race
Age between 18 and 40 years
Second pregnancy and after that
History of problems such as preterm delivery; intrauterine growth retardation; preeclampsia; induced gestational hypertension in previous pregnancy
The first visit to a medical center before the 16th week of pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Threat of miscarriage and placental abruption (bleeding) in the current pregnancy
Cervical cerclage
Having cardiovascular disease; kidney disease and lack of urinary tract infections; polyhydramnios; chronic lung disease; liver disease; hepatitis of any type; hyper and hypothyroidism; overt diabetes or gestational diabetes in previous pregnancies; diagnosis or suspicion of severe fetal abnormalities or hydrops in the current pregnancy
Substance abuse, alcohol and smoking; regular consumption of fish oil or nonsteroidal anti-inflammatory agents or other medications
Allergy to fish products
Lack of desire to take pill and irregular visit</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pre-existing hypertension complicating pregnancy, childbirth and the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Soft capsule of 1000 mg salmon oil (Omega 3), without mercury, containing essential fatty acids (fish oil and flaxseed oil) made in Iran, Zahravi Pharmaceutical Company, each capsule of which contains 180 mg of eicosapentaenoic acid and 120 mg Ducosahexaenoic acid, and from the 16th week to the end of pregnancy, one capsule a day was given and it was recommended to be taken orally with food and water; Routine pregnancy care was also provided for this group</i_keyword>
      <i_keyword>Control group: No intervention was performed and they only received routine pregnancy care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Newborn Weight. Timepoint: At birth time. Method of measurement: By means of newborns scale into gram.</prim_outcome>
      <prim_outcome>Apgar score in the first and fifth minutes. Timepoint: At birth time. Method of measurement: Observation and physical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Childbirth before 37 weeks. Timepoint: At the time of hospitalization. Method of measurement: Estimation of gestational age.</sec_outcome>
      <sec_outcome>Increase of blood pressure. Timepoint: From the 16th week of pregnancy on prenatal visits. Method of measurement: By Blood pressure control device.</sec_outcome>
      <sec_outcome>Mode of delivery. Timepoint: at birth time. Method of measurement: observation.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-06</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Highway, Yemen St., Shahid Arabi St., next to Ayatollah Taleghani Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
