<?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>IRCT2014010116025N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-18</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>Metformin is more effective than insulin in treating gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparing of the effectiveness of insulin and metformin in treating gestational diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>400</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15109</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>gestational diabetes.</hc_freetext>
      <i_freetext>Intervention 1: In the metformin group, the treatment will begin with 500 mg of metformin (produced by Apotex company, holding the trademark; Apo Metfromin). It will be given once or twice a day starting with meals so that within a 1 to 2 week’s time the target blood glucose is reached or to the maximum level of 2500 mg of daily dosage it will be increased. In case the treatment target is not reached through the mere consumption of metformin, three weeks (on average) after the beginning of metformin treatment, insulin will be added. If taking metformin is inhibited for the mother (if she suffers from some sort of liver, kidney disorder or sepsis) or detect intra uterin growth retardation stop the use of metformin. Intervention 2: Insulin will be used in a 0.5 to 1 unit/kg dosage dependent on the pregnancy age (in the 1st trimester: 0.5 unit/kg, 2nd trimester: 0.7 unit/kg and the 3rd trimester: 1 unit/kg). According to the Multi day injection rule, we will start with NPH and regular insulin.</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>Dr. Mojgan Rahbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 739 7863</telephone>
        <email>rahbar_mojgan@yahoo.com</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mojgan Rahbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 76 1333 2424</telephone>
        <email>rahbar_mojgan@yahoo.com</email>
        <affiliation>Hormozgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age ranging from 18 to 45; affliction with gestational diabetes according to the criteria pinpointed by Australian Diabetes in Pregnancy Society (ADIPS); pregnancy with a single embryo; 20th to 32th week of pregnancy; meeting the hospital’s common criteria concerning the beginning of insulin (after the diet intervention and physical exercises their capillary blood glucose after an overnight fast should be above 90 mg/dl or their 2hpp blood glucose measurement should be above 120.6 d.l.). Exclusion criteria: pre-pregnancy diabetes; metformin consumption; embryonic anomaly; hypertensive pregnancy disorders; pre-eclampsia; embryonic growth restriction and premature rupture.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus in pregnancy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the metformin group, the treatment will begin with 500 mg of metformin (produced by Apotex company, holding the trademark; Apo Metfromin). It will be given once or twice a day starting with meals so that within a 1 to 2 week’s time the target blood glucose is reached or to the maximum level of 2500 mg of daily dosage it will be increased. In case the treatment target is not reached through the mere consumption of metformin, three weeks (on average) after the beginning of metformin treatment, insulin will be added. If taking metformin is inhibited for the mother (if she suffers from some sort of liver, kidney disorder or sepsis) or detect intra uterin growth retardation stop the use of metformin.</i_keyword>
      <i_keyword>Insulin will be used in a 0.5 to 1 unit/kg dosage dependent on the pregnancy age (in the 1st trimester: 0.5 unit/kg, 2nd trimester: 0.7 unit/kg and the 3rd trimester: 1 unit/kg). According to the Multi day injection rule, we will start with NPH and regular insulin</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal blood glucose control. Timepoint: During pregnancy: every 2 weeks. Method of measurement: During pregnancy: every 2 weeks.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Birth weight. Timepoint: 2 hour after delivery. Method of measurement: Neonatal weight measurement.</sec_outcome>
      <sec_outcome>Birth height. Timepoint: 2 hour after delivery. Method of measurement: Baby Height gauges.</sec_outcome>
      <sec_outcome>Head circumference. Timepoint: 2 hour after delivery. Method of measurement: With using meter.</sec_outcome>
      <sec_outcome>Chest circumference. Timepoint: 2 hour after delivery. Method of measurement: With using meter.</sec_outcome>
      <sec_outcome>First minute apgar. Timepoint: One minute after delivery. Method of measurement: Apgar score.</sec_outcome>
      <sec_outcome>Fiftt minute apgar. Timepoint: Five minutes after delivery. Method of measurement: Apgar score.</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 and Technology, Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-16</approval_date>
        <contact_name>Hormozgan University of Medical Sciences</contact_name>
        <contact_address>The eastern side of Shahid Mohammadi hospital, Jomhouri Eslami Blvd Bandar Abbas  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
