<?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>IRCT2013031812840N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-12</date_registration>
      <primary_sponsor>Research Council of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of training on outcomes of  gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>A Comparison of two teaching methods on pregnancy outcomes in discharge of patients with gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12865</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: first initial questionnaire is completed by the researcher. In intervention group 1 in 2 sessions that every session takes 40 minutes in the form of individual or in groups,face to face training will be given in the case of gestational diabetes that the 30 minutes of lecture and 10 minutes will be allotted for questions and answers.Subjects that will be taught in the first sessions  include: definition of gestational diabetes, its causes, symptoms, those at risk, control and treatment of gestational diabetes include training on glycemic control, and subjects that will be taught in the second sessions include: Nutrition, physical activity and exercise, insulin, pregnancy follow-up.Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported. Intervention 2: Intervention 2: first initial questionnaire is completed by the researcher. In intervention group 2, the booklet contains all the study material provided to the intervention group 1 will be distributed by the patient. Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported. Intervention 3: Control group: first initial questionnaire is completed by the researcher. Patients in the control group would receive routine care hospital. Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.</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>Fateme Rahimikian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>F_rahimikian@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Rahimikian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>F_rahimikian@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery, Tehran 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>Inclusion criteria:&#13;
1.Gestational age of 28-36 weeks. &#13;
2.Hospitalized due to high blood sugar or gestational diabetes.&#13;
3. Failure to attend training classes on diabetes before study entry.&#13;
4. Literacy in reading and writing.&#13;
5. Lack of having any known physical or mental condition that makes training impossible.&#13;
Exclusion criteria:&#13;
1.absence in one of the training sessions.&#13;
2. Lack of desire to continue working with research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</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 arrising in pregnanncy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: first initial questionnaire is completed by the researcher. In intervention group 1 in 2 sessions that every session takes 40 minutes in the form of individual or in groups,face to face training will be given in the case of gestational diabetes that the 30 minutes of lecture and 10 minutes will be allotted for questions and answers.Subjects that will be taught in the first sessions  include: definition of gestational diabetes, its causes, symptoms, those at risk, control and treatment of gestational diabetes include training on glycemic control, and subjects that will be taught in the second sessions include: Nutrition, physical activity and exercise, insulin, pregnancy follow-up.Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.</i_keyword>
      <i_keyword>Intervention 2: first initial questionnaire is completed by the researcher. In intervention group 2, the booklet contains all the study material provided to the intervention group 1 will be distributed by the patient. Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.</i_keyword>
      <i_keyword>Control group: first initial questionnaire is completed by the researcher. Patients in the control group would receive routine care hospital. Immediately to 1 month postpartum, patients will be followed up by the researcher by telephone and record sheet which includes pregnancy outcomes associated with maternal hospitalizations or hospitalization due to maternal gestational diabetes, the number of hospitalizations, number of days of hospitalization, type of delivery, pregnancy-related outcomes such as infant birth weight, gestational age at birth, the first and fifth Apgar score will be complete.Also stillbirth cases will be reported.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal and fetal outcome of gestational diabetes. Timepoint: Immediately to 1 month postpartum. Method of measurement: Self-made recording sheet.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce costs and improve infant after delivery. Timepoint: Immediately to 1 month postpartum. Method of measurement: Self-made recording sheet.</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>Research Council of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-13</approval_date>
        <contact_name>School of Nursing and Midwifery, Tehran University of Medical Sciences</contact_name>
        <contact_address>Tohid square Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
