<?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>IRCT201406022892N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Islamic Azad University of Karaj Branch</primary_sponsor>
      <public_title>The effect of educational intervention on quality of life in pregnant women with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of self care education on   quality of life of women with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2779</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes mellitus in pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: In interventional group: The first and third groups, patients with a family member who help the most in his life are companied in four 45-minute sessions weekly for a month's in self care education program. In each session in a maximum 6 patients and 6 person helping the patient will attend. At the end of each self care education session will be provided booklet or pamphlet (the total of two booklets and four pamphlets), to the patients depending on the treatment. Educational pamphlets and booklets containing all of the above training sessions, so patient it should be remembered and used. Self care education program is prepared by reading books and articles, according to the educational needs and literacy of patients. Teaching methods will be consisting of direct methods (combination of face-to-face, lectures, group discussions and the use of educational films) and indirect methods (pamphlets and educational booklets). Implementation of this education will be done by Internal Medicine (Dialectologist), dietitian and research assistant. Patients will be followed in the two months after the training sessions, by telephone counseling every two weeks by a researcher individually and refer them to the end of each month to sampling centers for verbal question and answer session. Intervention 2: In control group:&#13;
In second and fourth group (control) patients received routine prenatal visits by Diabetologist and gynecologist or obstetrics for getting all necessary care routine but not get any self care education like as intervention group.</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>Zahra Mehdizadeh Tourzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of Medical Sciences, Nursing and Midwifery Faculty, Katouiezadeh Street, 45 Meters Golshahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3445 5635</telephone>
        <email>z_mehdizadeh_t@yahoo.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mani Mirfeizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, Islamic Azad University, Karaj Branch, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 26 3445 5635</telephone>
        <email>mani@kiau.ac.ir</email>
        <affiliation>Islamic Azad University Karaj Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Pregnant women with diagnosis of gestational diabetes and singleton pregnancies; disease is diagnosed by a specialist physician ; not suffering from any physical or mental diseases condition according to his medical records and statements ; No alcohol, smoking and drugs ; Wanted pregnancies ; Less than one month from the time of diagnosis of gestational diabetes is made ; Pregnant women with gestational diabetes are treated with human insulin (not analog); Maternal gestational age 20-24 weeks at the time of study entrance ; Pregnant women before and during the study has not followed a specific exercise program.&#13;
 Exclusion criteria: Mother is suffering from diagnosed diabetes before pregnancy; Multiple pregnancies; Patients are component medical or paramedical groups.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>024.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus arising in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In interventional group: The first and third groups, patients with a family member who help the most in his life are companied in four 45-minute sessions weekly for a month's in self care education program. In each session in a maximum 6 patients and 6 person helping the patient will attend. At the end of each self care education session will be provided booklet or pamphlet (the total of two booklets and four pamphlets), to the patients depending on the treatment. Educational pamphlets and booklets containing all of the above training sessions, so patient it should be remembered and used. Self care education program is prepared by reading books and articles, according to the educational needs and literacy of patients. Teaching methods will be consisting of direct methods (combination of face-to-face, lectures, group discussions and the use of educational films) and indirect methods (pamphlets and educational booklets). Implementation of this education will be done by Internal Medicine (Dialectologist), dietitian and research assistant. Patients will be followed in the two months after the training sessions, by telephone counseling every two weeks by a researcher individually and refer them to the end of each month to sampling centers for verbal question and answer session.</i_keyword>
      <i_keyword>In control group:&#13;
In second and fourth group (control) patients received routine prenatal visits by Diabetologist and gynecologist or obstetrics for getting all necessary care routine but not get any self care education like as intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Baseline (pre-intervention) and after three months. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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, Islamic Azad University of Karaj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-12</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University Karaj Branch</contact_name>
        <contact_address>Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj Karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
