<?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>IRCT2015102824753N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of self-care package on glycemic control and self efficacy in pregnant diabetic Women</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of  effectiveness of self-care package in pregnant diabetic women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>280</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20826</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: To randomize, block randomization method is used.</study_design>
      <phase>2</phase>
      <hc_freetext>Pregnancy Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will be trained based on an approved schedule and curriculum which is the result of a qualitative study with nominal group. Intervention can be as follows: educational program is delivered within six training sessions which are held every five days in the diabetes center. Training method will be group work. At most, eight pregnant women will participate in each session.Training include: face to face education by the use of slideshows, movie and an educational package in the form of a book. Insulin injection is taught by using a human body moulage. Relaxation training and appropriate pregnancy exercises will be taught to reduce stress in the participants in one session. Regarding the related topics, different methods of giving lecture, having a question-and-answer session and group discussion will be used. All the topics will be done by a trained researcher, and if necessary the patients is referred to a specialist (nutritionist, endocrinologist…). To becommitted to Supportive Self- Management Education (SSME), we consider a contact number for patients. Definitive component of intervention will be determined after the second stage of the researcher’s Thesis. Intervention 2: The Control group will be received  routine care of Clinic.</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>Mitra Kolivand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HafteTir Square, Faculty of Nursing and Midwifery, Shahroud, IRAN  Islamic Repub Of</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 232332394063</telephone>
        <email>mkolivand@shmu.ac.ir; mitrakolivand@kums.ac.ir; mitrakolivand@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Afsaneh Keramat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HafteTir Square, Shahroud University of Medical Sciences, Shahroud, IRAN</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 2332 3940</telephone>
        <email>keramat1@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being pregnant; having diabetes (gestational or overt) confirmed by reliable tests according to the Health Ministry guideline; being able to read and write in Persian; being able to answer the questionnaire independently and sign the consent letter; having no visual or hearing impairment or mental illnesses which needs medication or psychiatrist continuous care; and having no previous experience of participation in any diabetes self care training programs; not being addicted to alcohol; cigarette or drugs; gestational diabetes has been diagnosed not more than a month; gestational age should not be more than 28 weeks; the patient should not experience any intensive stressful events during the study.&#13;
  Exclusion criteria: refusing from cooperation in the study; being absent for two or more educational sessions; occurrence of high-risk pregnancy complications such as vaginal bleeding; preeclampsia; preterm labor; admission in hospital due to any reason; multiple pregnancy; the patient should not be a member of medical and paramedical staff.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.0, O24</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pre-existing diabetes mellitus, insulin-dependent, Pre-existing diabetes mellitus, non-insulin-dependent, Diabetes mellitus arising in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will be trained based on an approved schedule and curriculum which is the result of a qualitative study with nominal group. Intervention can be as follows: educational program is delivered within six training sessions which are held every five days in the diabetes center. Training method will be group work. At most, eight pregnant women will participate in each session.Training include: face to face education by the use of slideshows, movie and an educational package in the form of a book. Insulin injection is taught by using a human body moulage. Relaxation training and appropriate pregnancy exercises will be taught to reduce stress in the participants in one session. Regarding the related topics, different methods of giving lecture, having a question-and-answer session and group discussion will be used. All the topics will be done by a trained researcher, and if necessary the patients is referred to a specialist (nutritionist, endocrinologist…). To becommitted to Supportive Self- Management Education (SSME), we consider a contact number for patients. Definitive component of intervention will be determined after the second stage of the researcher’s Thesis.</i_keyword>
      <i_keyword>The Control group will be received  routine care of Clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy. Timepoint: baseline (pre-intervention) and one month after intervention. Method of measurement: by use of self-efficacy questionare of Stanford University.</prim_outcome>
      <prim_outcome>Blood sugar. Timepoint: baseline (pre-intervention) and one month after intervention. Method of measurement: level of fast blood sugar,and 2 hour post prandial.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal and neonatal results. Timepoint: in and after delivery. Method of measurement: Determining Apgar score, neonatal birth weight, method of delivery and neonatal admission.</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, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-13</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, HafteTirSquare, Shahroud, IRAN Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
