<?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>IRCT138707081281N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-15</date_registration>
      <primary_sponsor>National institute for medical research development</primary_sponsor>
      <public_title>Comparison of various protocoles for management of gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>To compare the maternal, fetal and cost-effectiveness outcomes in 5 different screening strategies for gestational diabetes among pregnant women with ≤ 14 weeks of gestation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39500</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: At first, five provinces in the different geographical regions of north, south, east, west and center of the country including Yazd, Khorasan, south Kordestan, Golestan and Bushehr will be invited. The 5 selected cities from each province will be interred to the study. In each province, based on socioeconomic differences the cities will be divided in to two cluster: the center of province and other cities. The 5 protocol will be randomly allocated among cities in this two cluster.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Protocol A: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by one step approach with OGTT -75 g Glucose. It will be considered as GDM, if one abnormal test detect. Intervention 2: Protocol B: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by one step approach with OGTT -75 g Glucose. It will be considered as GDM, if two abnormal test detect. Intervention 3: Protocol C: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by one step approach with OGTT -75 g Glucose. It will be considered as GDM, if one abnormal test detect. Intervention 4: Protocol D: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by two step approach with OGTT -100 g Glucose. Intervention 5: Protocol E: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by two step approach with OGTT -100 g Glucose.</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>Fahimeh Ramezani Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>24 Parvaneh, Yaman Street, Velenjak, P.O.Box:19395-4763</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2500</telephone>
        <email>ramezani@endocrine.ac.ir</email>
        <affiliation>Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences  Shahid Behesht</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Ramezani Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>24 Parvaneh, Yaman Street, Velenjak, P.O.Box:19395-4763</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2500</telephone>
        <email>ramezani@endocrine.ac.ir</email>
        <affiliation>Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences  Shahid Behesht</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: All 1st trimester pregnant women who refer from health centers of selected cities among 5 provinces will recruit to the study &#13;
Exclusion criteria: Preexisting diabetes; Prior gestational diabetes; A history of stillbirth; Multifetal gestation; Asthma; Chronic hypertension; Taking corticosteroids</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus arising in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Protocol A: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by one step approach with OGTT -75 g Glucose. It will be considered as GDM, if one abnormal test detect.</i_keyword>
      <i_keyword>Protocol B: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by one step approach with OGTT -75 g Glucose. It will be considered as GDM, if two abnormal test detect.</i_keyword>
      <i_keyword>Protocol C: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by one step approach with OGTT -75 g Glucose. It will be considered as GDM, if one abnormal test detect.</i_keyword>
      <i_keyword>Protocol D: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by two step approach with OGTT -100 g Glucose.</i_keyword>
      <i_keyword>Protocol E: In this protocol, the screening test in first pregnancy trimester will be fasting blood sugar (FBS). In addition, all of women with mild gestational diabetes will not receive standard treatment. If those women do not affected by GDM in the 1th screening test, they will invite for 2ed trimester of GDM screening at 24-28 weeks of gestations by two step approach with OGTT -100 g Glucose.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cost of health services including pregnancy, delivery and neonatal period. Timepoint: After expenses in each phase. Method of measurement: View, record and receive expenses factors.</prim_outcome>
      <prim_outcome>Quality-adjusted life years (QALYs). Timepoint: pregnancy, delivery and neonatal period. Method of measurement: Quality-adjusted life years (QALYs).</prim_outcome>
      <prim_outcome>Percentage of birth weight&gt;90th percentile. Timepoint: at the time of delivery. Method of measurement: Using fetal growth curves.</prim_outcome>
      <prim_outcome>Percentage of primary cesarean section. Timepoint: at the time of delivery. Method of measurement: View and registered cases of primary cesarean.</prim_outcome>
      <prim_outcome>Percentage of neonatal hypoglycemia. Timepoint: At first hour after birth. Method of measurement: Measurment the blood glucose levels using a laboratory glucose  kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Percentage of birth weight&lt;10th percentile. Timepoint: After delivery. Method of measurement: Using fetal growth curves.</sec_outcome>
      <sec_outcome>The percentage of admission to the neonatal intensive care unit. Timepoint: neonatal period (T the time of birth until day 28 after birth). Method of measurement: Observation and record.</sec_outcome>
      <sec_outcome>Birth trauma including fracture of clavicle, brachial plexus injury. Timepoint: At the time of delivery. Method of measurement: Observation and record.</sec_outcome>
      <sec_outcome>Still birth(intra uterine death). Timepoint: delivery. Method of measurement: delivery registry.</sec_outcome>
      <sec_outcome>Preeclampsia. Timepoint: 2nd and 3rd trimesters. Method of measurement: prenatal records.</sec_outcome>
      <sec_outcome>Preterm labor. Timepoint: delivery. Method of measurement: delivery registry.</sec_outcome>
      <sec_outcome>Shoulder dystocia. Timepoint: delivery. Method of measurement: delivery registry.</sec_outcome>
      <sec_outcome>Neonatal hyperbilirubinemia. Timepoint: neonatal period. Method of measurement: blood bilirubine.</sec_outcome>
      <sec_outcome>Neonatal hypocalcaemia. Timepoint: neonatal period. Method of measurement: blood calcium.</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>National institute for medical research development</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-01</approval_date>
        <contact_name>National institute for medical research development</contact_name>
        <contact_address>no.21 West Fatemi Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
