<?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>IRCT201602213027N35</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-13</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of intravenous dextrose 5% on delivery</public_title>
      <acronym></acronym>
      <scientific_title>Comparing parenteral 5% dextrose, ringer and oral intake on the duration of labor stages in nulliparous women: A double- blinded randomized, controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>201</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3005</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: 5% dextrose injection experimental group serum: serum administered dextrose 5% at a speed of 125 ml per hour in nulliparous women with vaginal delivery. Intervention 2: The intervention group injected Ringer: Ringer prescribed speed of 125 ml per hour in nulliparous women with vaginal delivery. Intervention 3: The control group received only oral liquid.</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>Fatemeh Ahadi Yulgunlu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Streat - City chaharborg</address>
        <city>chaharborg</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 4532 2868</telephone>
        <email>fatemehahadi8@gmail.com</email>
        <affiliation>Farzane Shahmohammadi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahime Sehhatie Shaffaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>blinding of Medical and Sciences University, Southern Shriati Streat, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3477 0648</telephone>
        <email>sehhatief@tbzmed.ac.ir</email>
        <affiliation>Medical and sciences of tabriz universcity</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being nulliparous, ages 18-35, gestational age (38-41 weeks), singleton pregnancy with cephalic presentation, onset of first stage of labor and 3-4 cm dilated, spontaneous onset of labor, maternal first trimester body mass index 18.5 &lt;BMI&lt;24.9 kg/m2, normal maternal pelvis (according to the experts and the researchers examinations), clinical and ultrasound prediction of no fetal macrosomia (weight more than 4.5 kg). Exclusion criteria: women with labor induction (indications of induction of labor such as prolonged rupture of membranes (over 18 h), gestational hypertension, nonreassuring fetal status, diabetes or preeclampsia), high risk pregnancies (gestational diabetes, preeclampsia, heart or kidney diseases, IUGR, detachment or placenta praevia,. ..) evidence of chorioamnionitis (maternal fever over 38oc) and fetal distress (abnormal NST), intrauterine fetal death, use of epidural</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>O80-O84</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>5% dextrose injection experimental group serum: serum administered dextrose 5% at a speed of 125 ml per hour in nulliparous women with vaginal delivery</i_keyword>
      <i_keyword>The intervention group injected Ringer: Ringer prescribed speed of 125 ml per hour in nulliparous women with vaginal delivery</i_keyword>
      <i_keyword>The control group received only oral liquid</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total of first stage of delivery. Timepoint: Since intervention to full dilatation. Method of measurement: Timer.</prim_outcome>
      <prim_outcome>Total of Second stage of delivery. Timepoint: Full Dilatation to delivery. Method of measurement: Timer.</prim_outcome>
      <prim_outcome>Total of Third stage of delivery. Timepoint: From birth to Exit placenta. Method of measurement: Timer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal outcomes (delivery type, frequency of use of oxytocin, the frequency of prolonged labor). Timepoint: Start deliveries until the end of maternity. Method of measurement: check list.</sec_outcome>
      <sec_outcome>Neonatal outcome (Apgar score). Timepoint: Immediately after delivery. Method of measurement: check list.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-18</approval_date>
        <contact_name>tabriz universityof medical sciences</contact_name>
        <contact_address>Central building, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
