<?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>IRCT2016092729902N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-08</date_registration>
      <primary_sponsor>Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences</primary_sponsor>
      <public_title>The effect of low trans fatty acid diet on adverse pregnancy outcomes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of low Trans Fatty Acid content diet on adverse pregnancy outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>800</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23919</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Intervention (dietary pattern with trans fatty acids&lt;1%) and control through blocked randomization in block sizes of four and six and with an allocation ratio of 1:1. To conceal the allocation, the type of intervention (dietary pattern with trans fatty acids&lt;1% or routine diet) was written on paper and placed into sequentially numbered opaque envelopes. The researcher opened the envelopes sequentially when a participant entered into the study, and, depending on the type of group written on the paper in the envelope, the participants were allocated to the relevant group. Blocking was done by a person not involved in the sampling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: preeclampsia. Condition 2: Low birth weight. Condition 3: Gestational diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake. we replaced mono- and polyunsaturated fatty acids with free of trans fatty acids in dietary pattern, such as olive oil, fish, nuts, and low fat (1.5%) dairy products, and participants were forbidden to consume the food rich of trans fatty acids such as any kind of fast foods, processed meat, and deep fried foods. Intervention 2: women received individualized dietary pattern without any focus on trans fatty acid content. women were allowed to consume any kind of dairy products and oil for cooking and routine dietary recommendation were advised.</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:
Low trans fatty acid and gestational diabetes mellitus
Low trans fatty acid and preeclampsia
Low trans fatty acid and low birth weight

When:
2018

To whom:
Public

Conditions:
No criteria need

Where to obtain:
Physicians
Midwifes
Health care giver

How to obtain:
No processes need

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seideh Hanieh Alamolhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1155673970</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>alamolhoda.h@gmail.com</email>
        <affiliation>Shahid Beheshti University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seideh Hanieh Alamolhoda</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1155673970</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>alamolhoda.h@gmail.com</email>
        <affiliation>Shahid Beheshti University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women aged 18-35 years.
Pregnant women who are less than 7 weeks pregnant.
Pregnant women with singleton pregnancies.
Pre pregnancy body mass index 19-25 kg/m2
Pregnant women who have a pre-pregnancy body mass index of 19-25 kg / m2.
Pregnant women who are literate.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnose fetal abnormalities in the current pregnancy.
Pregnant women with severe nausea and vomiting during pregnancy.
Pregnant women who smoke.
Pregnant women who drink alcohol.
Pregnant women who are addicted to drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O14</hc_code>
      <hc_code>P05.18</hc_code>
      <hc_code>O24.41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pre-eclampsia</hc_keyword>
      <hc_keyword>Newborn small for gestational age, 2000-2499 grams</hc_keyword>
      <hc_keyword>Gestational diabetes mellitus in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake. we replaced mono- and polyunsaturated fatty acids with free of trans fatty acids in dietary pattern, such as olive oil, fish, nuts, and low fat (1.5%) dairy products, and participants were forbidden to consume the food rich of trans fatty acids such as any kind of fast foods, processed meat, and deep fried foods.</i_keyword>
      <i_keyword>women received individualized dietary pattern without any focus on trans fatty acid content. women were allowed to consume any kind of dairy products and oil for cooking and routine dietary recommendation were advised.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preeclampsia. Timepoint: 28 weeks of pregnancy. Method of measurement: Midwifery questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gestational diabetes. Timepoint: 28 weeks of pregnancy. Method of measurement: Midwifery questionnaire.</sec_outcome>
      <sec_outcome>Low birth weight. Timepoint: At birth time. Method of measurement: Measurement with weight of Mark Seka.</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 Of Research, Shahid Beheshti University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-17</approval_date>
        <contact_name>Ethics Committee Of Shahid Beheshti University Of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
